MDx-Chex for BCP is intended for use as an external positive and negative assayed control to monitor the performance of the qualitative detection of Gram-positive bacteria and associated antimicrobial resistance genes, by the Diasorin LIAISON PLEX Gram-Positive Blood Culture assay on the LIAISON PLEX System. The MDx-Chex BCP Positive and Negative Controls are composed of a buffered solution with stabilized erythrocytes and leukocytes in a matrix of blood culture media components. Positive Control: Gram-positive bacteria: Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensis, Streptococcus agalactiae, Streptococcus anginosus group, Streptococcus pneumoniae, Streptococcus pyogenes, Enterococcus faecalis, Enterococcus faecium; genus: Bacillus spp., Listeria spp., Staphylococcus spp., Streptococcus spp.; antimicrobial resistance genes: mecA/mecC, vanA, and vanB. Negative Control: buffered solution only. This product is not intended to replace manufacturer controls provided with the device.
Device Story
MDx-Chex for BCP is a ready-to-use liquid quality control kit; contains two controls (positive and negative) for the Diasorin LIAISON PLEX Gram-Positive Blood Culture assay. Positive control contains stabilized human erythrocytes, leukocytes, inactivated Gram-positive bacteria, and resistance genes in a simulated blood culture media matrix; negative control contains buffered solution only. Used by laboratory technicians to monitor assay performance, including lysis, nucleic acid isolation, purification, inhibitor removal, DNA hybridization, and detection. Processed like a patient sample on the LIAISON PLEX system. Output is a qualitative result (detected/not detected) for specific pathogens and resistance genes. Helps ensure system accuracy, operator proficiency, and equipment installation verification. Benefits patient care by providing confidence in the reliability of clinical diagnostic results for blood culture assays.
Clinical Evidence
No clinical data. Bench testing only. Precision evaluated at one site (60 results) and reproducibility at three sites (90 results per control type). Combined reproducibility percent agreement was 99% (89/90) for positive controls and 98% (88/90) for negative controls. Matrix effect study confirmed performance in MDx-Chex matrix compared to clinical blood culture matrix (100% agreement). Stability testing supports 365-day shelf-life at 2-25°C.
Technological Characteristics
Ready-to-use liquid control; contains stabilized human erythrocytes, leukocytes, and inactivated bacteria/components in simulated blood culture media. Monitors lysis, nucleic acid isolation/purification, DNA hybridization, and detection. No energy source; standalone material. Sterilization not specified. Software algorithm is inherent to the LIAISON PLEX system, not the control material.
Indications for Use
Indicated for use by trained laboratory professionals as an external positive and negative assayed control to monitor the performance of the qualitative detection of Gram-positive bacteria and associated antimicrobial resistance genes in blood culture samples using the DiaSorin LIAISON PLEX Gram-Positive Blood Culture assay.
Regulatory Classification
Identification
An assayed quality control material for clinical microbiology assays is a device indicated for use in a test system to estimate test precision or to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. This type of device consists of single or multiple microbiological analytes intended for use with either qualitative or quantitative assays.
Special Controls
An assayed quality control material for clinical microbiology assays must comply with the following special controls: (1) Premarket notification submissions must include detailed device description documentation and information concerning the composition of the quality control material, including, as appropriate: (i) Analyte concentration; Expected values: (ii) Analyte source: (iii) (iv) Base matrix; (v) Added components; (vi) Safety and handling information; and, (vii) Detailed instructions for use. (2) Premarket notification submissions must include detailed documentation, including line data as well as detailed study protocols and a statistical analysis plan used to establish performance, including: (i) Description of the process for value assignment and validation. (ii) Description of the protocol(s) used to establish stability. (iii) Line data establishing precision/reproducibility. (iv) Where applicable, assessment of matrix effects and any significant differences between the quality control material and typical patient samples in terms of conditions known to cause analytical error or affect assay performance. (v) Where applicable, identify or define traceability or relationship to a domestic or international standard reference material and/or method. (vi) Where applicable, detailed documentation related to studies for surrogate controls. (3) Premarket notification submissions must include an adequate mitigation (e.g., realtime stability program) to the risk of false results due to potential modifications to the assays specified in the device's 21 CFR 809.10 compliant labeling. (4) Your 21 CFR 809.10 compliant labeling must include the following: (i) The intended use in your 21 CFR 809.10(a)(2) and 21 CFR 809.10(b)(2) compliant labeling must include the following: (A) Assayed control material analyte(s); (B) Whether the material is intended for quantitative or qualitative assays: (C) Stating if the material is a surrogate control; (D)The system(s), instrument(s), or test(s) for which the quality control material is intended. (ii) The intended use in your 21 CFR 809.10(a)(2) and 21 CFR 809.10(b)(2) compliant labeling must include the following statement: "This product is not intended to replace manufacturer controls provided with the device." (iii)A limiting statement that reads "Quality control materials should be used in accordance with local, state, federal regulations, and accreditation requirements."
*Classification.* Class II (special controls). The special controls for this device are:(1) Premarket notification submissions must include detailed device description documentation and information concerning the composition of the quality control material, including, as appropriate:
(i) Analyte concentration;
(ii) Expected values;
(iii) Analyte source;
(iv) Base matrix;
(v) Added components;
(vi) Safety and handling information; and
(vii) Detailed instructions for use.
(2) Premarket notification submissions must include detailed documentation, including line data as well as detailed study protocols and a statistical analysis plan used to establish performance, including:
(i) Description of the process for value assignment and validation.
(ii) Description of the protocol(s) used to establish stability.
(iii) Line data establishing precision/reproducibility.
(iv) Where applicable, assessment of matrix effects and any significant differences between the quality control material and typical patient samples in terms of conditions known to cause analytical error or affect assay performance.
(v) Where applicable, identify or define traceability or relationship to a domestic or international standard reference material and/or method.
(vi) Where applicable, detailed documentation related to studies for surrogate controls.
(3) Premarket notification submissions must include an adequate mitigation (e.g., real-time stability program) to the risk of false results due to potential modifications to the assays specified in the device's 21 CFR 809.10 compliant labeling.
(4) Your 21 CFR 809.10 compliant labeling must include the following:
(i) The intended use of your 21 CFR 809.10(a)(2) and (b)(2) compliant labeling must include the following:
(A) Assayed control material analyte(s);
(B) Whether the material is intended for quantitative or qualitative assays;
(C) Stating if the material is a surrogate control; and
(D) The system(s), instrument(s), or test(s) for which the quality control material is intended.
(ii) The intended use in your 21 CFR 809.10(a)(2) and (b)(2) compliant labeling must include the following statement: “This product is not intended to replace manufacturer controls provided with the device.”
(iii) A limiting statement that reads “Quality control materials should be used in accordance with local, state, federal regulations, and accreditation requirements.”
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FDA U.S. FOOD & DRUG ADMINISTRATION
# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
ASSAY ONLY
## I Background Information:
A 510(k) Number
K260041
B Applicant
Streck, LLC
C Proprietary and Established Names
MDx-Chex for BCP
D Regulatory Information
| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| PMN | Class II | 21 CFR 866.3920 - Assayed Quality Control Material For Clinical Microbiology Assays | MI - Microbiology |
## II Submission/Device Overview:
A Purpose for Submission:
To obtain a substantial equivalence determination for the MDx-Chex for BCP.
B Measurand:
Multi-analyte external quality control materials for microbiology NAAT assays.
C Type of Test:
QC materials to monitor the performance of the DiaSorin LIAISON PLEX Gram-Positive Blood Culture assay on the LIAISON PLEX System.
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
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K260041 - Page 2 of 8
## III Intended Use/Indications for Use:
### A Intended Use(s):
See Indications for Use below.
### B Indication(s) for Use:
MDx-Chex for BCP is intended for use as an external positive and negative assayed control to monitor the performance of the qualitative detection of Gram-positive bacteria and associated antimicrobial resistance genes, by the Diasorin LIAISON PLEX Gram-Positive Blood Culture assay on the LIAISON PLEX System. The MDx-Chex BCP Positive and Negative Controls are composed of a buffered solution with stabilized erythrocytes and leukocytes in a matrix of blood culture media components. Positive Control: Gram-positive bacteria: *Staphylococcus aureus*, *Staphylococcus epidermidis*, *Staphylococcus lugdunensis*, *Streptococcus agalactiae*, *Streptococcus anginosus* group, *Streptococcus pneumoniae*, *Streptococcus pyogenes*, *Enterococcus faecalis*, *Enterococcus faecium*; genus: *Bacillus* spp., *Listeria* spp., *Staphylococcus* spp., *Streptococcus* spp.; antimicrobial resistance genes: mecA/mecC, vanA, and vanB. Negative Control: buffered solution only. This product is not intended to replace manufacturer controls provided with the device.
### C Special Conditions for Use Statement(s):
Rx - For Prescription Use Only
### D Special Instrument Requirements:
DiaSorin LIAISON PLEX System.
## IV Device/System Characteristics:
### A Device Description:
MDx-Chex for BCP is a cellular-based external quality control containing stabilized blood components (erythrocytes and leukocytes), simulated blood culture media, and inactivated microorganisms. The control simulates positive and negative blood culture samples and is processed in "control mode" per the assay IFU. Use of full-process cellular controls enables evaluation of the entire analytical workflow for sample-to-result tests, including lysis, nucleic acid isolation/purification, hybridization, detection, and analysis, and provides assessment of the impact of inhibitors and pre-analytical variables. The device is intended to be used by trained laboratory professionals.
#### Kit configurations
MDx-Chex for BCP is packaged in a chipboard box containing a 10-hole insert. Each package contains five (5) Positive Control vials and five (5) Negative Control vials. Each control kit is
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supplied with 5 violet-capped $0.5\mathrm{mL}$ microtubes, each containing $300\mu \mathrm{L}$ of the Positive Control formulation, and 5 white-capped $0.5\mathrm{mL}$ microtubes, each containing $300\mu \mathrm{L}$ of the Negative Control formulation. Each tube contains enough reagent for 1 test.
MDx-Chex for BCP Verification Kit is packaged in the same chipboard box and contains a 20-hole insert. Each package contains ten (10) Positive Sample vials and ten (10) Negative Sample vials. Each packaged verification kit is supplied with 10 violet-capped $0.5\mathrm{mL}$ microtubes, each containing $300\mu \mathrm{L}$ of the Positive Control formulation, and 10 white-capped $0.5\mathrm{mL}$ microtubes, each containing $300\mu \mathrm{L}$ of the Negative Control formulation.
| Catalog Number | Product Name | Kit Configuration |
| --- | --- | --- |
| 250084 | MDx-Chex for BCP | (5) Positive Control vials and (5) Negative Control vials |
| 250087 | MDx-Chex for BCP Verification Kit | (10) Positive Sample vials and (10) Negative Sample vials |
The analyte composition for the Control set is described in Table 1, below.
Table 1: MDx-Chex for BCP Positive Control and Negative Control Results Summary.
| Gram-Positive Bacteria* | | |
| --- | --- | --- |
| Target | Positive Control | Negative Control |
| Staphylococcus aureus | Detected | Not Detected |
| Staphylococcus epidermidis | Detected | Not Detected |
| Staphylococcus lugdunensis | Detected | Not Detected |
| Streptococcus agalactiae | Detected | Not Detected |
| Streptococcus anginosus group | Detected | Not Detected |
| Streptococcus pneumoniae | Detected | Not Detected |
| Streptococcus pyogenes | Detected | Not Detected |
| Enterococcus faecalis | Detected | Not Detected |
| Enterococcus faecium | Detected | Not Detected |
| Bacillus spp. | Detected | Not Detected |
| Listeria spp. | Detected | Not Detected |
| Staphylococcus spp. | Detected | Not Detected |
| Streptococcus spp | Detected | Not Detected |
| Antimicrobial Resistance Genes* | | |
| mecA/mecC | Detected | Not Detected |
| VanA | Detected | Not Detected |
| VanB | Detected | Not Detected |
*All Bacteria analytes are sourced from ATCC, American Type Culture Collection
# B Principle of Operation:
Not applicable.
K260041 - Page 3 of 8
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V Substantial Equivalence Information:
A Predicate Device Name(s):
MDx-Chex for BC-GP
B Predicate 510(k) Number(s):
K231221
C Comparison with Predicate:
| Device & Predicate Device(s): | K260041 | K231221 |
| --- | --- | --- |
| Device Trade Name | MDx-Chex for BCP | MDx-Chex for BC-GP |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | MDx-Chex for BCP is intended for use as an external positive and negative assayed control to monitor the performance of the qualitative detection of Gram-positive bacteria and associated antimicrobial resistance genes, by the Diasorin LIAISON PLEX Gram-Positive Blood Culture assay on the LIAISON PLEX System. The MDx-Chex BCP Positive and Negative Controls are composed of a buffered solution with stabilized erythrocytes and leukocytes in a matrix of blood culture media components. Positive Control: Gram-positive bacteria: Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensis, Streptococcus agalactiae, Streptococcus anginosus group, Streptococcus pneumoniae, Streptococcus pyogenes, Enterococcus faecalis, Enterococcus faecium; genus: Bacillus spp., Listeria spp., Staphylococcus spp., Streptococcus spp.; antimicrobial resistance genes: mecA/mecC, vanA, and vanB. Negative Control: buffered solution only. This product is not | MDx-Chex for BC-GP is intended for use as an external positive and negative assayed control to monitor the performance of the qualitative detection of Gram-positive bacteria and associated antimicrobial resistance genes, by the Luminex VERIGENE ® Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) on Luminex VERIGENE ® systems. The MDx-Chex for BC-GP Positive and Negative Controls are composed of a buffered solution with stabilized erythrocytes and leukocytes in a matrix of blood culture media components. Positive Control: Gram-positive bacteria: Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensis, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, Enterococcus faecalis, Enterococcus faecium, Streptococcus anginosus; Species: Staphylococcus spp., Streptococcus spp., Listeria spp.; antimicrobial resistance genes: mecA, vanA, vanB. Negative Control: buffered solution only. This product is not intended to replace manufacturer controls provided with the device. |
K260041 - Page 4 of 8
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| | intended to replace manufacturer controls provided with the device. | |
| --- | --- | --- |
| Physical Format | Ready-to-Use Liquid | Same |
| Indications for Use | Process like patient sample | Same |
| Composition | MDx-Chex for BCP contains stabilized human leukocytes and erythrocytes, and the inactivated bacteria and bacteria components in simulated blood culture media as identified on table 1 above. | Same |
| Assay Steps Monitored | Lysis, nucleic acid isolation/purification/inhibitor removal, DNA hybridization, detection, identification/data reporting | Same |
| General Device Characteristic Differences | | |
| Number of targets monitored in one assay | Multiple, 16 Targets | Multiple, 15 Targets |
VI Standards/Guidance Documents Referenced:
Special Controls under 21 CFR 866.3920
ISO 15223-1:2021. Symbols to be used with information to be supplied by the manufacturer.
ISO 14971:2019. Medical Devices-Application of risk management to medical devices.
CLSI EP05-A3. Evaluation of Precision of Quantitative Measurement Procedures
VII Performance Characteristics (if/when applicable):
A Analytical Performance:
1. Precision/Reproducibility:
A. Single-site precision.
Within-laboratory precision was evaluated at one site, using three lots of positive and negative QC material, over 20 days, producing a total of 60 results per control type. Samples were prepared according to the MDx-Chex for BCP Instructions for Use (IFU) and tested using at least three Liaison PLEX BCP test cartridges on at least two DiaSorin LIAISON PLEX systems by at least two operators. The results from the initial run were
K260041 - Page 5 of 8
{5}
analyzed as percent agreement between the observed and expected value (positive or negative) for each run, with one or more discordant analyte rendering “unexpected” result for the entire run. The results are summarized in Table 2 below.
Table 2. Single-site precision of MDx-Chex for Blood Culture GP QC material.
| Category | Observed / Expected Results | Percent Agreement | 95% Confidence Interval |
| --- | --- | --- | --- |
| MDx-Chex for Blood Culture GP Positive Control | 59/60 | 98% | 91%-100% |
| MDx-Chex for Blood Culture GP Negative Control | 60/60 | 100% | 94%-100% |
B. Multisite reproducibility.
Reproducibility was evaluated at three sites using three lots (one lot per site) of positive and negative QC material at each site and 10 samples per lot per control type, producing a total of 30 results per site per control type. Samples were prepared according to the MDx-Chex for BCP IFU and analyzed with the DiaSorin LIAISON PLEX BCP assay and DiaSorin LIAISON PLEX systems. The results from the initial run were analyzed as percent agreement between the observed and expected value (positive or negative) for each run, with one or more discordant analyte rendering “unexpected” result for the entire run. The results are summarized in Table 3 below.
Table 3. Multisite reproducibility of MDx-Chex for Blood Culture GP QC material.
| Category | Site #1 | | Site #2 | | Site #3 | | Combined Percent Agreement (observed/expected) | 95% Confidence Interval |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | Observed/Expected Results | Percent Agreement | Observed/Expected Results | Percent Agreement | Observed/Expected Results | Percent Agreement | | |
| MDx-Chex for BCP Positive Control | 29/30 | 97% | 30/30 | 100% | 30/30 | 100% | 99% (89/90) | 94% - 100% |
| MDx-Chex for BCP Negative Control | 30/30 | 100% | 29/30 | 97% | 29/30 | 97% | 98% (88/90) | 92% - 100% |
2. Linearity:
N/A
3. Analytical Specificity/Interference:
N/A
4. Assay Reportable Range:
N/A
K260041 - Page 6 of 8
{6}
5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):
## Closed-Vial Stability.
Closed-Vial Stability was evaluated using three lots of QC material, two conditions (storage temperature 2-8°C or 20-25°C), and 20 samples for each combination of lot, condition, and QC type. The results demonstrated at least 90% agreement with the expected outcomes, and supported a claimed shelf-life of 365 days when stored at 2-25°C.
## Shipping Stability.
Shipping Stability was evaluated using one lot of QC material, two conditions (simulated shipping during summer or winter), and 20-25 samples for each QC type. Samples were stored at 2-8°C or 20-25°C prior to shipping simulation, exposed to extreme temperature profiles (summer: between 22°C and 40°C; winter: between -10°C and -22°C) for five days, then returned to their respective storage temperatures for seven days. Samples were tested within the 75-day close-vial stability testing period. The results demonstrated at least 90% agreement with the expected outcomes. Additional stability assessment may be performed at end-of-shelf-life to confirm product shelf-life claim after exposure to extreme shipping temperatures.
6. Detection Limit:
N/A
7. Assay Cut-Off:
N/A
## B Comparison Studies:
1. Method Comparison with Predicate Device:
N/A
2. Matrix Effect:
To evaluate the effect of the simulated blood culture matrix on the performance of the DiaSorin LIAISON PLEX BCP assay, one lot of Staphylococcus aureus (4,000,000 cells/mL final concentration) was spiked into MDx-Chex for BCP matrix and into BD BACTEC Plus Aerobic/F culture medium supplemented with negative whole blood to simulate a clinical sample. The simulated samples were tested in triplicate using DiaSorin LIAISON PLEX BCP assay. Additionally, non-spiked simulated samples were tested in triplicate using BCP assay serving as negative controls. The results are summarized in Table 4 below.
Table 4. Matrix effect on results of MDx-Chex for Blood Culture GP QC material.
| Matrix type | Observed/Expected results | Percent Agreement | 95% Confidence Interval |
| --- | --- | --- | --- |
| MDx-Chex for BCP Matrix + Staphylococcus aureus | 3/3 | 100% | 29% - 100% |
K260041 - Page 7 of 8
{7}
| Clinical Matrix + Staphylococcus aureus | 3/3 | 100% | 29% - 100% |
| --- | --- | --- | --- |
| MDx-Chex for BCP Matrix | 3/3 | 100% | 29% - 100% |
| Clinical Matrix | 3/3 | 100% | 29% - 100% |
C Clinical Studies:
1. Clinical Sensitivity:
N/A
2. Clinical Specificity:
N/A
3. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):
N/A
D Clinical Cut-Off:
N/A
E Expected Values/Reference Range:
The expected values for each analyte are either “detected” or “not detected”. Refer to section IV.A. Device Description, Table 1.
VIII Proposed Labeling:
The labeling supports the finding of substantial equivalence for this device.
IX Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
K260041 - Page 8 of 8
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Learn the FDA Browser
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
