The DNA/RNA Shield™ SafeCollection Kit is intended for the collection, inactivation, stabilization, and transportation, of unprocessed saliva specimens suspected of containing SARS-CoV-2. The DNA/RNA Shield™ SafeCollect Saliva Collection Kit is intended to transport and store saliva specimens at ambient temperature (20-25°C) from the collection site to the laboratory. Specimens collected and preserved in a DNA/RNA Shield™ Saliva Collection kit sample collection tube are suitable for use with legally marketed molecular diagnostic devices.
Device Story
Device is a saliva collection kit comprising a tube pre-filled with DNA/RNA Shield transport media, a collection funnel, and a cap with a 'Safe Puncture' tip. Used under healthcare provider supervision; patient deposits saliva into funnel; user replaces funnel with cap. Twisting cap breaks internal foil seal, releasing transport media to mix with saliva. Media inactivates SARS-CoV-2 and lyses cells, stabilizing viral RNA for transport/storage at ambient temperature (20-25°C). Device is used in clinical settings to facilitate sample transport to laboratories for molecular diagnostic testing. Benefits include safe handling of potentially infectious specimens and preservation of RNA integrity for up to 21 days.
Clinical Evidence
Bench testing only. Analytical sensitivity (LoD) study determined a final LoD of 250 GEC/mL for SARS-CoV-2 in saliva using the Quick SARS-CoV-2 rRT-PCR Kit. Stability study confirmed SARS-CoV-2 RNA remains stable in saliva for 21 days at room temperature (20-25°C) with ≤10% deviation from day 0. Inactivation study demonstrated at least a 2-log reduction of SARS-CoV-2 virus titer after 30 minutes of incubation in the transport media.
Technological Characteristics
Tube pre-filled with DNA/RNA Shield media (inactivation buffer, salts, pH buffer, water). Features a foil seal barrier and Safe Puncture tip mechanism. Single-use, non-sterile. Ambient temperature storage. No electronic components or software.
Indications for Use
Indicated for the collection, inactivation, stabilization, and transport of unprocessed saliva specimens suspected of containing SARS-CoV-2 for use with molecular diagnostic devices. For prescription use only.
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.
{0}
FDA
U.S. FOOD & DRUG
ADMINISTRATION
# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
ASSAY ONLY
## I Background Information:
A 510(k) Number
K231013
B Applicant
Zymo Research
C Proprietary and Established Names
DNA/RNA Shield SafeCollect Saliva Collection Kit
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 Zymo Research DNA/RNA Shield SafeCollect Saliva Collection kits for the collection, transport and storage of saliva specimens to the laboratory for downstream testing.
B Measurand:
Storage and stability of nucleic acids from SARS-CoV-2 in saliva
C Type of Test:
SARS-CoV-2 nucleic acid storage and stabilization device
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
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III Intended Use/Indications for Use:
A Intended Use(s):
See Indications for Use below.
B Indication(s) for Use:
The DNA/RNA Shield SafeCollect Saliva Collection Kit is intended for the collection, inactivation, stabilization, and transportation, of unprocessed saliva specimens suspected of containing SARS-CoV-2. The DNA/RNA Shield SafeCollect Saliva Collection Kit is intended to transport and store saliva specimens at ambient temperature (20-25°C) from the collection site to the laboratory. Specimens collected and preserved in a DNA/RNA Shield SafeCollect Saliva Collection kit sample collection tube are suitable for use with legally marketed molecular diagnostic devices.
C Special Conditions for Use Statement(s):
Rx - For Prescription Use Only
D Special Instrument Requirements:
None.
IV Device/System Characteristics:
A Device Description:
The DNA/RNA Shield SafeCollect Saliva Tube consists of a tube pre-filled with DNA/RNA Shield transport media. DNA/RNA Shield is a transport media that ensures stability of SARS-CoV-2 RNA during sample transport/storage at ambient temperatures and is intended to inactivate SARS-CoV-2, effectively lyses cells from collected saliva specimens.
The DNA/RNA Shield SafeCollect Saliva Tube contains a foil seal barrier that sequesters the DNA/RNA Shield transport media inside of the tube, until the cap, with a Safe Puncture tip is used to seal the DNA/RNA Shield SafeCollect Saliva tube. When the foil seal barrier is broken by the Safe Puncture Tip, the specimen is then allowed to mix with the DNA/RNA Shield transport media.
The DNA/RNA Shield SafeCollect Saliva Collection Kit consists of a DNA/RNA Shield SafeCollect Saliva Tube, a funnel designed for the collection of human saliva samples, and a cap with a Safe Puncture tip. Sample collection is conducted under the supervision of a healthcare provider. The user deposits their saliva into the collection tube with the aid of the attached funnel, the user removes the funnel and replaces it with the cap. Upon twisting and closing the Safe Puncture tip cap, the DNA/RNA Shield is released into the tube and mixes with the saliva.
B Principle of Operation:
K231013 - Page 2 of 10
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The media components are intended to inactivate SARS CoV-2 capsids, disrupt/lyse lipid membranes, denature proteins, inactivate enzymes, and stabilize SARS CoV-2 RNA. The transport device is designed for storage of saliva for up to 21 days.
Do not mix with sodium hypochlorite. The media contains the following reagents:
- Inactivation buffer
- Salts
- pH buffer
- Water
V Substantial Equivalence Information:
A Predicate Device Name(s):
DNA/RNA Shield Collection Tube
B Predicate 510(k) Number(s):
K202641
C Comparison with Predicate(s):
| Device & Predicate Device(s): | Device: K231013 | Predicate: K202641 |
| --- | --- | --- |
| Device Trade Name | DNA/RNA Shield SafeCollect Saliva Collection Kit | DNA/RNA Shield Collection Tube |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | The DNA/RNA Shield SafeCollect Saliva Collection Kit is intended for the collection, inactivation, stabilization, and transportation, of unprocessed saliva specimens suspected of containing SARS-CoV-2. The DNA/RNA Shield SafeCollect Saliva Collection Kit is intended to transport and store saliva specimens at ambient temperature (20-25°C) from the collection site to the laboratory. Specimens collected | The DNA/RNA Shield collection tube is intended for the stabilization and inactivation of upper and lower respiratory human specimens suspected of containing SARS-CoV-2. These devices can be used for collection transport and storage of specimens at ambient temperatures (20-25°C). Specimens collected and stored in a DNA/RNA Shield collection tube are suitable for use with legally marketed |
K231013 - Page 3 of 10
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| | and preserved in a DNA/RNA Shield™ SafeCollect Saliva Collection kit sample collection tube are suitable for use with legally marketed molecular diagnostic devices. | molecular diagnostic devices. |
| --- | --- | --- |
| Analyte | SARS-CoV-2 RNA | Same |
| Sample stability | 20-25°C | Same |
| Collection media | DNA/RNA Shield media | Same |
| Special conditions for use | For prescription use only
For in-vitro diagnostics use only | Same |
| General Device Characteristic Differences | | |
| Sample collection | Saliva | Upper and lower respiratory specimens |
| RNA Stabilization at room temperature | Saliva: up to 21 days | Upper/lower respiratory tract samples: up to 28 days |
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:
N/A
2. Linearity:
N/A
3. Analytical Specificity/Interference:
N/A
4. Assay Reportable Range:
K231013 - Page 4 of 10
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N/A
5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):
## Shelf life
The shelf life for the DNA/RNA Shield SafeCollect Saliva Collection kit is six months after the date of manufacture, based on current real-time stability data. The real-time stability of the DNA/RNA Shield SafeCollect Saliva Collection kit with media was assessed using a total of three lots. Stability studies looked for bacterial and fungal growth in the media along with properties of the media, appearance, pH, voltage resistance and density.
## Sterilization
The DNA/RNA Shield SafeCollect Saliva Tube with media are not sold as sterile nor are they intended to be sterilized by the user. These vials are single use devices that do not require cleaning by the operator.
6. Performance Studies:
a) Detection Limit:
An analytical sensitivity study was conducted to determine the Limit of Detection (LoD) of SARS-CoV-2 when detected in saliva samples collected using the DNA/RNA Shield SafeCollect Saliva Collection kit in combination with the authorized Quick SARS-CoV-2 rRT-PCR Kit for SARS-CoV-2 detection. To determine a preliminary LoD, SARS-CoV-2 negative saliva was used as a clinical matrix collected in DNA/RNA Shield SafeCollect Saliva Collection Kit and spiked with inactivated SARS-CoV-2. The preliminary LoD was determined with the lowest concentration for which 5/5 independent replicates tested positive. Results for the preliminary LoD determination are in Table 1. below.
Table 1: Preliminary LoD
| Concentrations Tested (GEC/mL) | Replicates | SARS-CoV-2 Targets | Interpretation | Call Rate |
| --- | --- | --- | --- | --- |
| 8.3 x 10^{4}
(5,000 GEC/rxn) | 1 | 27.33 | Positive | 5/5 |
| | 2 | 28.03 | Positive | |
| | 3 | 27.73 | Positive | |
| | 4 | 27.60 | Positive | |
| | 5 | 27.73 | Positive | |
| 8.3 x 10^{3}
(500 GEC/rxn) | 1 | 29.77 | Positive | 5/5 |
| | 2 | 28.83 | Positive | |
| | 3 | 29.33 | Positive | |
| | 4 | 29.64 | Positive | |
| | 5 | 29.97 | Positive | |
| 8.3 x 10^{2}
(50 GEC/rxn) | 1 | 32.37 | Positive | 5/5 |
| | 2 | 32.95 | Positive | |
| | 3 | 32.31 | Positive | |
| | 4 | 32.88 | Positive | |
| | 5 | 32.49 | Positive | |
| 83 | 1 | 39.54 | Positive | 5/5 |
K231013 - Page 5 of 10
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To confirm the LoD, inactivated SARS-CoV-2 was spiked into negative saliva specimens and 20 replicates were independently processed. The lowest concentration at which all 5 replicates were positive in the preliminary LoD (i.e., 83 GEC/mL) was used as a starting point for the confirmatory LoD study. Therefore, concentrations above 83 GEC/mL (increasing by factor 2) were tested until $\geq 19/20$ replicates tested positive. The final LoD for saliva was determined to be at the lowest concentration at which $\geq 19/20$ replicates test positive. The final LoD was determined to be 250 GEC/ml (15 GEC/rxn). Results of the confirmatory LoD study for saliva specimens are in Table 2 below.
Table 2: Confirmatory LoD Determination
| Concentrations Tested (GEC/mL) | Replicates | SARS-CoV-2 Targets | Interpretation | Call Rate |
| --- | --- | --- | --- | --- |
| 250 (15 GEC/rxn) | 1 | 34.62 | Positive | 19/20 |
| | 2 | 34.83 | Positive | |
| | 3 | 33.99 | Positive | |
| | 4 | N/A | Negative | |
| | 5 | 35.84 | Positive | |
| | 6 | 33.94 | Positive | |
| | 7 | 35.25 | Positive | |
| | 8 | 35.01 | Positive | |
| | 9 | 33.99 | Positive | |
| | 10 | 33.69 | Positive | |
| | 11 | 34.01 | Positive | |
| | 12 | 34.03 | Positive | |
| | 13 | 35.32 | Positive | |
| | 14 | 34.46 | Positive | |
| | 15 | 35.84 | Positive | |
| | 16 | 35.56 | Positive | |
| | 17 | 33.76 | Positive | |
| | 18 | 35.33 | Positive | |
| | 19 | 34.00 | Positive | |
| | 20 | 33.56 | Positive | |
| 166 (10 GEC/rxn) | 1 | 35.57 | Positive | 17/20 |
| | 2 | 35.35 | Positive | |
| | 3 | 35.78 | Positive | |
| | 4 | N/A | Negative | |
| | 5 | 33.80 | Positive | |
K231013 - Page 6 of 10
{6}
| | 6 | 34.42 | Positive | |
| --- | --- | --- | --- | --- |
| | 7 | 35.19 | Positive | |
| | 8 | 35.01 | Positive | |
| | 9 | 34.87 | Positive | |
| | 10 | 36.17 | Positive | |
| | 11 | N/A | Negative | |
| | 12 | 34.25 | Positive | |
| | 13 | 37.80 | Positive | |
| | 14 | N/A | Negative | |
| | 15 | 34.64 | Positive | |
| | 16 | 35.44 | Positive | |
| | 17 | 35.51 | Positive | |
| | 18 | 35.46 | Positive | |
| | 19 | 36.05 | Positive | |
| | 20 | 34.66 | Positive | |
| 83
(5 GEC/rxn) | 1 | 41.48 | Inconclusive | 13/20 |
| | 2 | 37.02 | Positive | |
| | 3 | 37.57 | Positive | |
| | 4 | 37.07 | Positive | |
| | 5 | N/A | Negative | |
| | 6 | 36.54 | Positive | |
| | 7 | 37.17 | Positive | |
| | 8 | 37.25 | Positive | |
| | 9 | 35.21 | Positive | |
| | 10 | N/A | Negative | |
| | 11 | 37.08 | Positive | |
| | 12 | N/A | Negative | |
| | 13 | 35.57 | Positive | |
| | 14 | N/A | Negative | |
| | 15 | N/A | Negative | |
| | 16 | N/A | Negative | |
| | 17 | 34.74 | Positive | |
| | 18 | 35.01 | Positive | |
| | 19 | 35.03 | Positive | |
| | 20 | 35.54 | Positive | |
Conclusion:
The DNA/RNA Shield SafeCollect medium used to collect saliva, and the Authorized Quick SARS-CoV-2 2rRT-PCR Kit reached a SARS-CoV-2 LoD of 250 GEC/mL (15 GEC/reaction) for saliva specimens, which is equivalent to the established LoD of the authorized reference assay.
b) Stability of SARS-CoV-2 in saliva specimens:
The room temperature (20-25 °C) stability of SARS-CoV-2 in DNA/RNA Shield SafeCollect Saliva kit was established by spiking 3X LoD of SARS-CoV-2 (750 GEC/ml) (see LoD section VII.A.6.a above) into negative saliva specimens collected using the DNA/RNA Shield SafeCollect Saliva Collection Kit and stored at room temperature in a time course
K231013 - Page 7 of 10
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study of 21 days. The room temperature stability of SARS-CoV-2 was measured using the Quick SARS-CoV-2 rRT-PCR Kit at day 0, 1, 2, 3, 4, 5, 6, 7, 14, and 21. Results are summarized in Table 3.
Table 3. SARS-CoV-2 Stability
| Concentration Tested | Days at Room Temperature | Replicates | Average Ct (Standard Deviation) | Call Rate |
| --- | --- | --- | --- | --- |
| Low Positive 3x LoD (750 GEC/mL) | Day 0 | 3 | 33.75 (0.21) | 3/3 |
| | Day 1 | 3 | 33.37 (0.22) | 3/3 |
| | Day 2 | 3 | 34.10 (0.35) | 3/3 |
| | Day 3 | 3 | 33.93 (0.32) | 3/3 |
| | Day 4 | 3 | 34.24 (0.97) | 3/3 |
| | Day 5 | 3 | 34.34 (0.24) | 3/3 |
| | Day 6 | 3 | 34.75 (0.87) | 3/3 |
| | Day 7 | 3 | 34.44 (0.41) | 3/3 |
| | Day 14 | 3 | 33.98 (0.36) | 3/3 |
| | Day 21 | 3 | 34.05 (0.48) | 3/3 |
Conclusion:
There is no significant change in stability over time and the data are within the acceptance criteria (≤+/-10% deviation from day 0). Stability is determined by acceptable data that supports the stability claim and does not exceed day 0 by a 3-log range. Therefore, SARS-CoV-2 is stable in saliva specimens collected using the DNA/RNA Shield SafeCollect Saliva Collection kit for up to 21 days when stored at room temperature (20-25 °C).
c) Inactivation:
An inactivation study was conducted to test DNA/RNA Shield SafeCollect Saliva Collection kit media ability to inactivate SARS-CoV-2. The inactivation study used a stock titer of 9×10⁵ PFU/mL for SARS-CoV-2. The study was performed in a Biosafety Level 3 (BSL-3) facility.
Stock SARS-CoV-2 was spiked into DNA/RNA Shield media (at a ratio of 1:3 using 100 μL of viral stock was mixed with 300 μL of DNA/RNA Shield SafeCollect medium). The virus and media mixture were incubated for 30 mins at room temperature. The mixture was then serial diluted in cell culture medium and added to confluent monolayers of VeroE6 cells. Cells and media were incubated at 37°C in 5% CO₂ for one hour with gentle rocking every 15 minutes. Media was aspired and 1.0 mL of pre-warmed overlay media was added. Cells were incubated for two days, fixed in 10% formaldehyde, and stained with 0.5% crystal violet to enable plaque visualization and enumeration. A positive control (untreated viral stock) and negative control (media only) were included in each run. A no-virus media control (DNA/RNA Shield media only) was also included to assess whether the media was cytotoxic. The study was replicated three independent times.
Inactivation rate:
The DNA/RNA Shield media showed no cytotoxicity on veroE6 cells when the media was diluted 1:1,000 with cell culture media. The 1:1,000 dilution factor is needed to avoid
K231013 - Page 8 of 10
{8}
cytotoxic effects the DNA/RNA Shield media has on the cell monolayer. The mixture of SARS-CoV-2 and DNA/RNA Shield media combined for 30 minutes demonstrated at least a 2-log reduction in SARS-CoV-2. Greater than a 2-log reduction of SARS-CoV-2 could not be quantified based on the starting concentration of the virus compounded by the need to dilute the DNA/RNA Shield media 1:1000. CPE could not be observed at < 3.0 logs due to the cytotoxic effects of the DNA/RNA Shield media.
Conclusion:
Zymo DNA/RNA shield inactivates SARS-CoV2 when incubated for at least 30 minutes at room temperature.
## 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
## E Expected Values/Reference Range:
N/A
## VIII Proposed Labeling:
The labeling supports the finding of substantial equivalence for this device.
K231013 - Page 9 of 10
{9}
IX Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
K231013 - Page 10 of 10
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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.
