The Zhejiang GENE SCIENCE Co., Ltd.'s Sample Preservation Solution is intended for the collection, inactivation, preservation/stabilization, and transport of unprocessed upper respiratory clinical specimens from individuals suspected of influenza A infection by their healthcare provider. Specimens collected with the Sample Preservation Solution can be stored and transported at 4 °C or at room temperature (20-25°C) for preservation of microbial nucleic acid until the sample is processed and used with compatible molecular diagnostic assays.
Device Story
Device is a non-sterile, single-use polypropylene collection tube pre-filled with 2 mL or 3 mL of preservation medium. Input: unprocessed upper respiratory clinical specimens (swabs). Operation: chemical lysis and stabilization via guanidine isothiocyanate, EDTA, Tris-HCl, yeast RNA, TWEEN-20, and phenol red. Device inactivates influenza A virus and stabilizes viral RNA for transport/storage at 4-25°C. Used by healthcare providers in clinical settings. Output: stabilized specimen for downstream molecular diagnostic assays. Benefits: enables safe handling of potentially infectious samples and preserves nucleic acid integrity for accurate diagnostic testing.
Clinical Evidence
No clinical data. Bench testing only. Viral inactivation study demonstrated >6.2 log reduction of influenza A virus at 5 minutes. Nucleic acid stability study confirmed stability of influenza A RNA for 6 days at 4°C and room temperature (20-25°C), with Ct value changes within ±3.0 of T₀. Limit of Detection (LoD) confirmed at 10² copies/mL with 100% positivity agreement.
Technological Characteristics
Polypropylene screw-cap collection tube; 2 mL or 3 mL fill volumes. Chemical composition: guanidine isothiocyanate, EDTA, Tris-HCl, yeast RNA, TWEEN-20, phenol red, and in vitro diagnostic grade water. Non-sterile, single-use. Shelf-life: 24 months at 20-25°C.
Indications for Use
Indicated for collection, inactivation, preservation, and transport of unprocessed upper respiratory clinical specimens from individuals suspected of influenza A infection. For use by healthcare providers.
Regulatory Classification
Identification
A microbial nucleic acid storage and stabilization device is a device that consists of a container and reagents intended to stabilize microbial nucleic acids in human specimens for subsequent isolation and purification of nucleic acids for further molecular testing. The device is not intended for preserving morphology or viability of microorganisms.
Special Controls
The special controls for this device are: (1) The intended use for the 21 CFR 809.10 labeling must include a detailed description of microorganisms and types of human specimens intended to be preserved. (2) The 21 CFR 809.10(b) labeling must include: (i) A detailed device description, including all device components. (ii) Performance characteristics from applicable analytical studies, including but not limited to, nucleic acid stability and microorganism inactivation. (iii) A limiting statement that erroneous results may occur when the transport device is not compatible with molecular testing. (iv) A limiting statement that the device has only been validated to preserve the representative microorganisms used in the analytical studies. (3) Design verification and validation must include the following: (i) Overall device design including all device components and all control elements incorporated into the analytical validation procedures. (ii) Thorough description of the microorganisms and methodology used in the validation of the device including, but not limited to, extraction platforms and assays used for the detection of preserved nucleic acids. (iii) The limit of detection (LoD) of the molecular test used to establish microorganism nucleic acid stability.
*Classification.* Class II (special controls). The special controls for this device are:(1) The intended use for the labeling required under § 809.10 of this chapter must include a detailed description of microorganisms and types of human specimens intended to be preserved.
(2) The labeling required under § 809.10(b) of this chapter must include the following:
(i) A detailed device description, including all device components;
(ii) Performance characteristics from applicable analytical studies, including nucleic acid stability and microorganism inactivation;
(iii) A limiting statement that erroneous results may occur when the transport device is not compatible with molecular testing; and
(iv) A limiting statement that the device has only been validated to preserve the representative microorganisms used in the analytical studies.
(3) Design verification and validation must include the following:
(i) Overall device design, including all device components and all control elements incorporated into the analytical validation procedures;
(ii) Thorough description of the microorganisms and methodology used in the validation of the device including, extraction platforms and assays used for the detection of preserved nucleic acids; and
(iii) The limit of detection (LoD) of the molecular test used to establish microorganism nucleic acid stability.
Predicate Devices
Copan eNAT Molecular Collection and Preservation Medium (K201849)
Submission Summary (Full Text)
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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
K212878
B Applicant
Zhejiang GENE SCIENCE Co., Ltd.
C Proprietary and Established Names
Sample preservation solution
D Regulatory Information
| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| QBD | Class II | 21 CFR 866.2950 - Microbial Nucleic Acid Storage And Stabilization Device | MI - Microbiology |
## II Submission/Device Overview:
A Purpose for Submission:
To obtain a substantial equivalence determination for the Zhejiang GENE SCIENCE Co., Ltd.'s Sample Preservation Solution for the collection, inactivation, preservation/ stabilization, and transport of unprocessed upper respiratory clinical specimens containing influenza A virus.
B Measurand:
Inactivation of viral particles and stabilization of nucleic acids from influenza A virus upon storage in the subject device.
C Type of Test:
Microbial Inactivation and Nucleic Acid Stability assays
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
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K212878 - Page 2 of 9
# III Intended Use/Indications for Use:
## A Intended Use(s):
See Indications for Use below.
## B Indication(s) for Use:
The Zhejiang GENE SCIENCE Co., Ltd.'s Sample Preservation Solution is intended for the collection, inactivation, preservation/stabilization, and transport of unprocessed upper respiratory clinical specimens from individuals suspected of influenza A infection by their healthcare provider. Specimens collected with the Sample Preservation Solution can be stored and transported at 4 °C or at room temperature (20-25°C) for preservation of microbial nucleic acid until the sample is processed and used with compatible molecular diagnostic assays.
## C Special Conditions for Use Statement(s):
Rx - For Prescription Use Only
## D Special Instrument Requirements:
Not Applicable
# IV Device/System Characteristics:
## A Device Description:
The Zhejiang GENE SCIENCE Co., Ltd.'s Sample Preservation Solution consists of a plastic, polypropylene screw-cap collection tube filled with non-sterile sample preservation medium. The tubes are pre-filled with either 2 mL (suitable for swabs with flocking length of 20-24 mm) or 3 mL (suitable for swabs with flocking length of 24-30 mm) of solution. The device is non-sterile, single use. Swabs are not included.
The Zhejiang GENE SCIENCE Co., Ltd.'s Sample Preservation Solution is offered in the following configurations:
| SKU or Catalog Number | Device Description | Pack Size |
| --- | --- | --- |
| YA-02 | 2.0 mL/tube | 100pcs/Tray, 15 Trays/Box |
| YA-03 | 3.0 mL/tube | 100pcs/Tray, 15 Trays/Box |
## B Principle of Operation:
The Zhejiang GENE SCIENCE Co., Ltd.'s Sample Preservation Solution consists of the following: Guanidine isothiocyanate, EDTA, Tris-HCl, Yeast RNA, TWEEN-20, Phenol red, and in vitro diagnostic grade water. The guanidine isothiocyanate lyses cells, denatures proteins, and inhibits nuclease activity, thereby stabilizing nucleic acids. EDTA is a chelating agent that deactivates RNAse and stabilizes RNA. Tris-HCl is a pH buffer system to maintain reagent pH. Yeast RNA serves as blocking agent, protects RNA, helps coprecipitating microbial nucleic acid. TWEEN-20 is a detergent that disrupts membranes and denatures proteins. Phenol red is a pH
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indicator which serves as a visual quality control mechanism. The in vitro diagnostic grade water serves as a diluent to adjust molarity of the buffer/preservation medium.
V Substantial Equivalence Information:
A Predicate Device Name(s):
eNAT molecular collection and preservation medium
B Predicate 510(k) Number(s):
K201849
C Comparison with Predicate(s):
| Device & Predicate Device(s): | Subject Device: K212878 | Predicate: K201849 |
| --- | --- | --- |
| Device Trade Name | Sample Preservation Solution | Copan eNAT Molecular Collection and Preservation Medium |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | The Zhejiang GENE SCIENCE Co., Ltd.'s Sample Preservation Solution is intended for the collection, inactivation, preservation/stabilization, and transport of unprocessed upper respiratory clinical specimens from individuals suspected of influenza A infection by their healthcare provider. Specimens collected with the Sample Preservation Solution can be stored and transported at 4 °C or at room temperature (20-25°C) for preservation of microbial nucleic acid until the sample is processed and used with compatible molecular diagnostic assays. | Copan eNAT is intended for the collection, inactivation and transport of clinical specimens containing influenza A viruses from the collection site to the testing laboratory. eNAT can be processed and used with compatible molecular assays that require stabilization of nucleic acids from influenza A viruses. |
| Specimen Type | Upper respiratory specimens | Same |
K212878 - Page 3 of 9
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| Analyte tested | Influenza A | Same |
| --- | --- | --- |
| Single Use Device | Yes | Same |
| General Device Characteristic Differences | | |
| Ingredients | Guanidine isothiocyanate
EDTA
Tris-HCl
Yeast RNA
TWEEN-20
Phenol red
In Vitro Diagnostic grade water | Tris-EDTA
Guanidine thiocyanate
Detergent
HEPES
Distilled water |
| Specimen stability | Preserves influenza A RNA for up to 6 days at 4-25 °C | Preserves influenza A RNA for up to 28 days at 2-25°C |
| Inactivation of influenza A | >6.2 log reduction in concentration at 5 minutes | >4.0 log reduction in concentration at 10 seconds |
| Shelf-life | 24 months | 18 months |
VI Standards/Guidance Documents Referenced:
Special controls that are applicable to regulation 21 CFR 866.2950.
VII Performance Characteristics (if/when applicable):
A Analytical Performance:
1. Precision/Reproducibility:
Not Applicable
2. Linearity:
Not Applicable.
3. Analytical Specificity/Interference:
Not Applicable.
4. Assay Reportable Range:
Not Applicable.
5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):
K212878 - Page 4 of 9
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# Shelf Life:
Three lots of $3\mathrm{mL}$ specification of the Zhejiang GENE SCIENCE Co., Ltd.'s Sample Preservation Solution device were used to conduct the following studies to evaluate physical characteristics. The product was assessed qualitatively at each time point to determine agreement with specifications for appearance (packaging has good seal, no damage, leakage, or deformation; the label is clean, clear, and complete; the color of the reagent is consistent, no precipitation, no impurities). Additionally, $\mathsf{pH}$ and evaporation were assessed to confirm the $\mathsf{pH}$ of $(7.3 + 0.2)$ and a limit of evaporation up to $\geq 97\%$ of the loading volume. The product met these acceptance criteria under all conditions.
The shelf-life of the Zhejiang GENE SCIENCE Co., Ltd.'s Sample Preservation Solution was assessed by storing three lots of the product at room temperature $(20 - 25^{\circ}\mathrm{C})$ for 0, 1, 3, 6, 12, 15, 18, 21, and 24 months in their Finished Product warehouse to test the real storage environment. At each time point, appearance, pH and loading volume were assessed for each product lot in triplicate and test results met the quality requirements. The Zhejiang GENE SCIENCE Co., Ltd.'s Sample Preservation Solution results after 24 months of storage showed that the actual volume was no less than $97\%$ of the theoretical volume, the appearance was acceptable, and the pH was $7.3 + 0.2$ . There was no leakage or deformation, showing that the product met the predefined quality standards.
# 6. Detection Limit:
To determine the Limit of Detection (LoD) of H1N1 influenza A virus stored in the Sample preservation solution, an LoD study was conducted using a validated RT-PCR assay. In brief, a serial dilution of contrived H1N1 influenza A virus samples were prepared by spiking the virus into human upper respiratory matrix and Sample Preservation Solution into five groups of final concentration $(10^{5}, 10^{4}, 10^{3}, 10^{2}$ and 10 copies/mL). Each concentration was tested in 4 replicates to establish the preliminary LoD. Samples were extracted with the Qiagen RNeasy Mini Kit and RT-PCR was performed using the Invitrogen SuperScript III Platinum One-Step Quantitative Kit on the ThermoFisher ABI 7500 Instrument. The preliminary LoD was determined to be $10^{2}$ copies/mL and confirmed by performing 20 replicates with a $100\%$ positivity agreement, average Ct value was 30.9 with a SD of 0.94. (Table 1-2).
Table 1: Preliminary LoD Determination
| Replicates | Concentration (copies/mL) (Ct <40) | | | | |
| --- | --- | --- | --- | --- | --- |
| | 105 | 104 | 103 | 102 | 101 |
| 1 | 27 | 28 | 31 | 33 | 40 |
| 2 | 24 | 28 | 31 | 32 | 40 |
| 3 | 25 | 27 | 32 | 37 | 42 |
| 4 | 24 | 29 | 31 | 35 | 39 |
| Total Positive | 4/4 | 4/4 | 4/4 | 4/4 | 1/4 |
K212878 - Page 5 of 9
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Table 2: Confirmation of LoD
| ThermoFisher ABI 7500 Instrument (10² copies/mL) | Influenza A (Ct<40) | Interpretation | Total Positive/Tested |
| --- | --- | --- | --- |
| 1 | 31 | Positive | 20/20 |
| 2 | 32 | Positive | |
| 3 | 31 | Positive | |
| 4 | 31 | Positive | |
| 5 | 31 | Positive | |
| 6 | 30 | Positive | |
| 7 | 31 | Positive | |
| 8 | 30 | Positive | |
| 9 | 31 | Positive | |
| 10 | 30 | Positive | |
| 11 | 31 | Positive | |
| 12 | 32 | Positive | |
| 13 | 31 | Positive | |
| 14 | 31 | Positive | |
| 15 | 32 | Positive | |
| 16 | 31 | Positive | |
| 17 | 31 | Positive | |
| 18 | 29 | Positive | |
| 19 | 29 | Positive | |
| 20 | 33 | Positive | |
| Mean | 30.9 | | |
| SD | 0.94 | | |
7. Nucleic Acid Sample Stability:
To determine nucleic acid stability of the Zhejiang GENE SCIENCE Co., Ltd.'s Sample Preservation Solution, three lots of Sample Preservation Solution of varying ages (one month, and two various age lots near expiration) were tested. Contrived swabs samples were prepared by spiking with 3 x LoD influenza A in negative upper respiratory swab matrix. Triplicate contrived swab samples were immersed into the Sample Preservation Solution and incubated for time 0, 3 day and 6 days at 4±1°C and room temperature (20-25°C) for each lot of Sample Preservation Solution. At the end of each time point samples were extracted with the Qiagen RNeasy Mini Kit and RT-PCR testing was performed using the Invitrogen SuperScript III Platinum One-Step Quantitative Kit on the ThermoFisher ABI 7500 Instrument.
Average Ct values were calculated per lot at each time point. Comparison of values obtained at each time point to the average T₀ values indicated similar results regardless of the lot age. Overall, when results of all lots were combined a decrease in the Ct values of 0.43 and of 2.76 Ct was observed for the samples stored at 4±1°C for 3 and 6 days, respectively (Table 3). For the samples stored at room temperature (20-25°C), an increase in the Ct values of 0.57 and 0.44 was observed for the samples stored for 3 and 6 days, respectively, meeting the pre-defined acceptance criteria of (+/-) 3.0 Ct from the initial time zero value (Table 3).
K212878 - Page 6 of 9
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Table 3: Influenza A nucleic acid Stability in Sample Preservation Solution*
| Time | 4 °C | | Room temperature (20-25 °C) | |
| --- | --- | --- | --- | --- |
| | Average Ct (Mean ± SD) | Average Δ Ct from T₀ | Average Ct (Mean ± SD) | Average Δ Ct from T₀ |
| 0 | 35.43 ± 0.38 | N/A | 35.43 ± 0.75 | N/A |
| 3 Day | 35.0 ± 0 | -0.43 | 36.0 ± 0.73 | 0.57 |
| 6 Day | 32.67 ± 0.35 | -2.76 | 35.87± 1.8 | 0.44 |
*Data for all age lots were combined since no differences were noted.
Overall, the nucleic acid study results support the ability of Zhejiang GENE SCIENCE Co., Ltd.’s Sample Preservation Solution to stabilize the Influenzas A RNA up to 6 days at 4°C and room temperature (20-25°C)
8. Viral Inactivation:
A viral inactivation study was conducted to test the ability of GENE SCIENCE Co., Ltd.’s Sample Preservation Solution to inactivate Influenza A virus.
a. Cytotoxicity: To determine cytotoxicity of Zhejiang GENE SCIENCE Co., Ltd. Sample Preservation Solution, three (3) lots at varying ages were examined. Each sample preservation solution was serially diluted with diluent to create 2, 4, 8, 16, 32, 64, and 128-fold dilutions. Each dilution was inoculated to cell monolayers in triplicate and examined for Cytopathic Effect (CPE). The lowest dilution to indicate normal cell growth (i.e., no cytotoxicity) was determined to be the 64-fold dilution.
b. Viral Inactivation: To determine the degree of viral inactivation produced by the Zhejiang GENE SCIENCE Co., Ltd. Sample Preservation Solution, three (3) lots of varying ages were examined. Upper respiratory matrix in saline was spiked with ≥10⁷ copies per mL of influenza A virus (A/PR/8/34 H1N1) in a 1:1 suspension to create spiked upper respiratory swab samples for the following three groups.
i. Test Group (Cₜ): Using a new swab, spiked upper respiratory swab samples (~0.08 mL) were inserted into the collection device with 3 mL of Sample Preservation Solution. They were then exposed for 0, 5, and 10 minutes. At the end of the exposure, samples were diluted 1:64 which was determined not to be toxic to the cell culture monolayer, inoculated onto the host cell monolayers, incubated 7 days, observed daily for CPE. The remaining infectivity (log TCID₅₀) was calculated and corrected using a dilution factor to account for the 1:64 dilution of Sample Preservation Solution to the diluent Medium to avoid cytotoxicity (dilution factor is 1.81 log) and the initial dilution of 0.08 ml into 3.08 ml (dilution factor is 1.58 log).
ii. Positive Control Group (C₀): Using a new swab, spiked upper respiratory samples (~0.08 mL) were inserted into a collection tube containing 3 mL of diluent (0.85% saline). They were then exposed for 0, 5, and 10 minutes. At the end of the exposure, samples were diluted 1:64 which was determined not to be toxic to the cell culture monolayer, inoculated onto the host cell monolayers,
K212878 - Page 7 of 9
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incubated 7 days, and observed daily for CPE. Log TCID₅₀ was calculated and corrected using the dilution factors described above.
iii. Negative Control Group (Cₙ): Upper respiratory swab matrix only samples (~0.08 mL) were inserted into the collection device with 3 mL Sample Preservation Solution and exposed for 0, 5, and 10 minutes. At the end of the exposure, samples were diluted 1:64 which was determined not to be toxic to the cell culture monolayer, inoculated onto the host cell monolayers, incubated 7 days, observed daily for CPE. No CPE was observed, confirming that he 1:64 dilution eliminated the cell toxicity produced by the Sample Preservation Solution.
Using the Inactivation (log reduction) formula below, Influenza A viral inactivation rate of Zhejiang GENE SCIENCE Co., Ltd’s. Sample Preservation Solution was determined to be >6.2 log reduction at 5 minutes which was equivalent to greater than 99.99% inactivation Influenza A virus (Table 4).
Inactivation (log reduction): Mv = log (C0/Ct) = log(C0)-log (Ct)
Table 4: Influenza A Viral Inactivation in Sample Preservation Solution
| Time (min) | Inactivation (log reduction, Mv) | | |
| --- | --- | --- | --- |
| | Lot#1 | Lot#2 | Lot#3 |
| 0 | >6.97 | >6.97 | 3.28 |
| 5 | >6.20 | >6.20 | >6.20 |
| 10 | >6.75 | >6.75 | >6.75 |
Conclusion:
Zhejiang GENE SCIENCE Co., Ltd’s. Sample Preservation Solution inactivates Influenza A virus when incubated for at least 5 minutes.
9. Assay Cut-Off:
Not Applicable.
B Comparison Studies:
1. Method Comparison with Predicate Device:
Not Applicable.
2. Matrix Comparison:
Not Applicable.
K212878 - Page 8 of 9
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C Clinical Studies:
1. Clinical Sensitivity:
Not Applicable.
2. Clinical Specificity:
Not Applicable.
3. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):
Not Applicable.
D Clinical Cut-Off:
Not Applicable.
E Expected Values/Reference Range:
Not Applicable.
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.
K212878 - Page 9 of 9
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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.
