Multichem ID-G is intended for use as a qualitative positive quality control serum to monitor the precision of laboratory testing procedures for Anti-HBc IgG, Anti-HCV IgG, HBsAg, Anti-Treponema pallidum IgG, and Anti-HIV 1 IgG detected by the Roche cobas heterogeneous immunoassay systems. These products are not intended to replace manufacturer’s recommended controls provided in their package insert. Quality Control materials should be used in accordance with local, state, federal regulations, and accreditation requirements. Multichem ID-GNeg is intended for use as a qualitative negative quality control serum to monitor the precision of laboratory testing procedures for Anti-HBc IgG, Anti-HCV IgG, HBsAg, Anti-Treponema pallidum IgG, and Anti-HIV 1 IgG detected by the Roche cobas heterogeneous immunoassay systems. These products are not intended to replace manufacturer’s recommended controls provided in their package insert. Quality Control materials should be used in accordance with local, state, federal regulations, and accreditation requirements.
Device Story
Multichem ID-G and Multichem ID-GNeg are liquid quality control (QC) materials derived from human plasma; used to monitor precision of Roche cobas immunoassay systems. Multichem ID-G is spiked with specific analytes (HBsAg, anti-HIV-1 IgG, anti-HCV IgG, anti-HBc IgG, anti-Treponema pallidum IgG) to target specifications; Multichem ID-GNeg contains no such analytes. Used in clinical laboratories by technicians/operators; processed alongside patient samples. Healthcare providers compare observed QC results against established target ranges to verify assay performance; ensures reliability of patient test results. Benefits include standardized monitoring of assay precision, reducing risk of erroneous clinical decisions due to instrument or reagent drift.
Clinical Evidence
Bench testing only. Precision and reproducibility evaluated using Roche cobas e 801 analyzers across multiple sites and lots. Precision study (20 days, 2 replicates/run, 2 runs/day) and reproducibility study (150 replicates total) demonstrated acceptable performance metrics (SD and %CV) for all analytes. Stability studies support 11-month shelf-life and 90-day open-vial stability at 2-8°C.
Technological Characteristics
Liquid human plasma-based controls. Analytes: HBsAg, anti-HIV-1 IgG, anti-HCV IgG, anti-HBc IgG, anti-Treponema pallidum IgG. Storage: 2-8°C. Shelf-life: 11 months. Open-vial stability: 30 days. Compatible with Roche cobas e 402 and e 801 systems.
Indications for Use
Indicated for use as qualitative positive and negative quality control serum to monitor precision of laboratory testing procedures for Anti-HBc IgG, Anti-HCV IgG, HBsAg, Anti-Treponema pallidum IgG, and Anti-HIV 1 IgG on Roche cobas heterogeneous immunoassay systems.
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
K242492
B Applicant
Techno-Path Manufacturing, Ltd.
C Proprietary and Established Names
Multichem ID-G (09339892190); Multichem ID-G (SR102G); Multichem ID-G (SR102MG); Multichem ID-GNeg (09339906190); Multichem ID-GNeg (SR102N); Multichem ID-GNeg (SR102MN)
D Regulatory Information
| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| QCH | Class II | 21 CFR 866.3920 - Assayed Quality Control Material For Clinical Microbiology Assays | MI - Microbiology |
## II Submission/Device Overview:
### A Purpose for Submission:
Clearance of the Quality Control (QC) material for Roche cobas assays detecting analytes anti-HIV-1 (Human Immunodeficiency Virus Type 1) IgG, anti-HBc (Hepatitis B Core Antigen) IgG, anti-HCV (Hepatitis C Virus) IgG, Hepatitis B Surface Antigen (HBsAg), and anti-Treponema pallidum IgG.
### B Measurand:
- Anti-HIV-1 IgG,
- Anti-HBc IgG,
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
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- Anti-HCV IgG,
- HBsAg,
- Anti-Treponema pallidum IgG.
## C Type of Test:
QC materials to monitor the performance of *in-vitro* testing for the qualitative detection of human HBsAg, anti-HIV-1 IgG, anti-HCV IgG, anti-HBc IgG, and anti-Treponema pallidum IgG assays performed with the Roche immunoassays on the Roche cobas systems.
## III Intended Use/Indications for Use:
### A Intended Use(s):
See Indications for Use below.
### B Indication(s) for Use:
Multichem ID-G is intended for use as a qualitative positive quality control serum to monitor the precision of laboratory testing procedures for Anti-HBc IgG, Anti-HCV IgG, HBsAg, Anti-Treponema pallidum IgG, and Anti-HIV 1 IgG detected by the Roche cobas heterogeneous immunoassay systems. These products are not intended to replace manufacturer’s recommended controls provided in their package insert. Quality Control materials should be used in accordance with local, state, federal regulations, and accreditation requirements.
Multichem ID-GNeg is intended for use as a qualitative negative quality control serum to monitor the precision of laboratory testing procedures for Anti-HBc IgG, Anti-HCV IgG, HBsAg, Anti-Treponema pallidum IgG, and Anti-HIV 1 IgG detected by the Roche cobas heterogeneous immunoassay systems. These products are not intended to replace manufacturer’s recommended controls provided in their package insert. Quality Control materials should be used in accordance with local, state, federal regulations, and accreditation requirements.
### C Special Conditions for Use Statement(s):
Rx - For Prescription Use Only
### D Special Instrument Requirements:
The performance of Multichem ID-G and Multichem ID-GNeg was evaluated on the Roche cobas systems e 402 (K220134 cleared on 09/16/2022), and e 801 (K162606 cleared on 01/23/2017).
## IV Device/System Characteristics:
### A Device Description:
Multichem ID-G and Multichem ID-GNeg are each supplied as single level controls. These products are prepared from human plasma. Multichem ID-G contains Hepatitis B Surface
K242492 - Page 2 of 8
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Antigen (HBsAg), and IgG antibodies to HIV-1, HCV, HBc and Treponema pallidum.
Multichem ID-GNeg does not contain analytes for HBsAg, anti-HIV-1 IgG, anti-HCV IgG, anti-HBc IgG, and anti-Treponema pallidum IgG. These controls are provided in liquid form for convenience. Each control is available as either 1 or 4 vials x 4 ml/vial.
Multichem ID-G is manufactured by adding the required analytes to the negative delipidated human serum base matrix, described above. Human disease state plasma that has tested positive for the required analyte using an FDA-cleared/approved assay is used to spike the base matrix to each target specification and within the ranges set for the Roche Immunoassay systems (Tables 1 and 2).
Table 1: Design Input Specifications for Multichem ID-G on the Roche Assays.
| ANALYTES | Product Specification UNITS | Positive When: | TARGET | LOW | HIGH |
| --- | --- | --- | --- | --- | --- |
| Anti-HIV-1 IgG | COI | >1 | 4.0 | 2.5 | 6.0 |
| Anti-HCV IgG | COI | >1 | 10.0 | 3.0 | 12.0 |
| Anti-Treponema pallidum IgG | COI | >1 | 2.0 | 1.5 | 4.0 |
| Anti-HBc IgG | COI | <1 | 0.5 | 0.2 | 0.8 |
| HBsAg | COI | >1 | 2.5 | 1.5 | 5.0 |
Table 2: Specifications for Raw Material Analyte Volume in the final product.
| Analytes | Raw Material I.D. Number | Origin | Raw Material Analyte Volume (mL) |
| --- | --- | --- | --- |
| HBsAg | RMR-32108 | Australia | 6.0 mL |
| anti-HIV 1 IgG | RMR-32103 | Australia | 1.5 mL |
| anti-HCV IgG | RMR-32105 | Australia | 0.4 mL |
| anti-Treponema palladium IgG | RMR-32106 | Australia | 28.6 mL |
| anti-HBc IgG | RMR-32107 | Australia | 12.5 mL |
B Principle of Operation:
Used as QC in accordance with the assay's Instructions for Use.
V Substantial Equivalence Information:
A Predicate Device Name(s):
Elecsys Anti-HAV II
B Predicate 510(k) Number(s):
K190428
C Comparison with Predicate(s):
| Device & Predicate Device(s): | K190428 | K242492 |
| --- | --- | --- |
K242492 - Page 3 of 8
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K242492 - Page 4 of 8
VI Standards/Guidance Documents Referenced:
Special Controls under 21 CFR 866.3920
| Device Trade Name | PreciControl Anti-HAV II | Multichem ID-G/Multichem ID-GNeg |
| --- | --- | --- |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | PreciControl Anti-HAV II is used for quality control of the Elecsys Anti-HAV II immunoassay on cobas e immunoassay analyzers. | Multichem ID-G/ID-GNeg is intended for use as a qualitative positive/negative quality control serum to monitor the precision of laboratory testing procedures for Anti-HBc IgG, Anti-HCV IgG, HBsAg, Anti-Treponema pallidum IgG, and Anti-HIV 1 IgG detected by the Roche cobas heterogeneous immunoassay systems. These products are not intended to replace manufacturer’s recommended controls provided in their package insert. Quality Control materials should be used in accordance with local, state, federal regulations, and accreditation requirements. |
| Summary | PreciControl Anti-HAV II is a ready-for-use control serum based on human serum both in the negative and positive concentration range. The controls are used for monitoring the performance of the Elecsys Anti-HAV II immunoassay. | Multichem ID-GNeg/Multichem ID-G is designed for and intended to be used solely with the procedures and immunoassays indicated in the Instructions for Use. These products are not intended to replace manufacturer’s recommended controls provided in their package insert. |
| General Device Characteristic Differences | | |
| Form: | Liquid | Liquid |
| Matrix: | Human blood | Human blood |
| Storage: | 2–8 °C | 2–8°C |
| Open Vial Stability: | 8 weeks at 2–8 °C | 30 days at 2–8°C |
| Shelf Life: | 15 months at 2–8 °C | Multichem ID-G: 11 months at 2–8°C
Multichem ID-GNeg: 11 months at 2–8°C |
| Analyte(s): | Antibodies against hepatitis A virus (HAV) | anti-HIV-1 IgG anti-HBc IgG anti-HCV IgG HBsAg
anti-Treponema pallidum IgG |
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# VII Performance Characteristics (if/when applicable):
# A Analytical Performance:
# 1. Precision/Reproducibility:
A. Precision.
Within-laboratory precision was evaluated using Roche assays Elecsys HIV Duo, Elecsys anti-HCV II, Elecsys Syphilis, Elecsys anti-HBc II and Elecsys HBsAg II. Testing was performed on Roche cobas e 801, using 3 lots of QC material that were tested in 2 replicates per run, 2 runs per day, for 20 days. A total of 240 replicates for each control were tested. The results are summarized in table 3.
Table 3. Within-laboratory precision of Multichem ID-G and Multichem ID-GNeg.
| Immunoassay System | QC (POS/NEG) | COI | Repeatability | | Within-Laboratory Precision | |
| --- | --- | --- | --- | --- | --- | --- |
| | | | SD (COI) | %CV | SD (COI) | %CV |
| anti-HIV | POS | 2.01 | 0.040 | 1.9 | 2.023 | 1.9 |
| | NEG | 0.18 | 0.010 | 4.0 | 0.180 | 0.0 |
| anti-HCV | POS | 11.74 | 0.080 | 0.7 | 0.240 | 2.0 |
| | NEG | 0.06 | 0.003 | 3.1 | 0.004 | 6.7 |
| anti-HBc | POS | 0.53 | 0.006 | 0.0 | 0.014 | 0.0 |
| | NEG | 2.29 | 0.030 | 1.3 | 0.030 | 1.3 |
| HBsAg | POS | 2.96 | 0.075 | 0.0 | 0.108 | 0.0 |
| | NEG | 0.37 | 0.023 | 6.2 | 0.025 | 6.9 |
| anti-T. pallidum | POS | 2.17 | 0.060 | 2.9 | 0.060 | 2.9 |
| | NEG | 0.14 | 0.000 | 2.0 | 0.140 | 0.00 |
# B. Reproducibility.
Reproducibility was evaluated using Roche assays Elecsys HIV Duo, Elecsys anti-HCV II, Elecsys Syphilis, Elecsys anti-HBc II and Elecsys HBsAg II. Testing was performed at 2 sites on analyzers Roche cobas e 801 using 3 QC lots that were tested in 5 replicates per run, 1 run per day, over 5 days. A total of 150 replicates for each control were tested. The results are summarized in table 4.
Table 4. Reproducibility of Multichem ID-G and Multichem ID-GNeg.
| Immunoassay system | Component | Positive | | | Negative | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | COI | Standard Deviation (COI) | % CV | COI | Standard Deviation (COI) | % CV |
| HIV Ab | Repeatability (Within-Run) | 2.00 | 0.03 | 1.51 | 0.20 | 0.01 | 2.98 |
| | Between-Day/Run | | 0.01 | 0.57 | | 0.00 | 0.00 |
| | Between-Lot | | 0.02 | 1.05 | | 0.00 | 1.41 |
K242492 - Page 5 of 8
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| | Between-Site | | 0.20 | 9.23 | | 0.00 | 0.96 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | Total Reproducibility | | 0.20 | 9.42 | | 0.01 | 4.67 |
| anti-HCV | Repeatability (Within-Run) | 11.89 | 0.13 | 1.12 | 0.10 | 0.00 | 3.44 |
| | Between-Day/Run | | 0.07 | 0.55 | | 0.00 | 1.90 |
| | Between-Lot | | 0.15 | 1.31 | | 0.00 | 0.00 |
| | Between-Site | | 0.09 | 0.76 | | 0.00 | 3.93 |
| | Total Reproducibility | | 0.23 | 1.96 | | 0.00 | 5.56 |
| Anti-HBc | Repeatability (Within-Run) | 0.53 | 0.01 | 1.56 | 2.10 | 0.02 | 1.08 |
| | Between-Day/Run | | 0.00 | 0.55 | | 0.00 | 0.00 |
| | Between-Lot | | 0.01 | 2.33 | | 0.00 | 0.14 |
| | Between-Site | | 0.02 | 4.50 | | 0.06 | 2.76 |
| | Total Reproducibility | | 0.03 | 5.34 | | 0.07 | 2.96 |
| Syphilis | Repeatability (Within-Run) | 2.11 | 0.04 | 1.82 | 0.10 | 0.01 | 8.28 |
| | Between-Day/Run | | 0.03 | 1.64 | | 0.00 | 3.38 |
| | Between-Lot | | 0.06 | 2.96 | | 0.00 | 0.00 |
| | Between-Site | | 0.20 | 10.25 | | 0.02 | 13.17 |
| | Total Reproducibility | | 0.22 | 10.95 | | 0.02 | 15.92 |
| HBsAg | Repeatability (Within-Run) | 3.10 | 0.0928 | 3.0 | 0.42 | 0.0300 | 7.1 |
| | Between-Day/Run | | 0.0396 | 1.3 | | 0.0166 | 3.9 |
| | Between-Lot | | 0.0531 | 1.7 | | 0.0000 | 0.0 |
| | Between-Site | | 0.2367 | 7.6 | | 0.0644 | 15.3 |
| | Total Reproducibility | | 0.2627 | 8.5 | | 0.0730 | 17.3 |
2. Linearity:
N/A
3. Analytical Specificity/Interference:
N/A
K242492 - Page 6 of 8
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4. Assay Reportable Range:
N/A
5. Stability:
Stability was evaluated using Roche assays Elecsys HIV Duo, Elecsys anti-HCV II, Elecsys Syphilis, Elecsys anti-HBc II and Elecsys HBsAg II. Testing was performed at 1 site using 3 QC lots that were tested in 3 replicates at month 0, 11, 24, and 35 for shelf-life at 2-8°C or at days 0, 90, and 91 for open vial stability at 2-8°C.
Stability studies supported a shelf-life claim of 11 months at the intended storage conditions (2-8°C) and open-vial claim of 90 days when stored at 2-8°C. Technopath requested a 30-day open vial claim for Multichem ID-GNeg and Multichem ID-G.
6. Detection Limit:
N/A
7. Assay Cut-Off:
N/A
B Comparison Studies:
1. Method Comparison with Predicate Device:
N/A
2. Matrix Comparison:
N/A
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
K242492 - Page 7 of 8
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K242492 - Page 8 of 8
E Expected Values/Reference Range:
Multichem ID-G and Multichem ID-GNeg are qualitative controls. The expected results are listed in 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.
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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.
