The Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA is a homogenous enzyme immunoassay for the qualitative analysis of carisoprodol metabolite, Meprobamate, at a cutoff of 280 ng/mL in human urine. The assay is intended for use in laboratories with automated clinical chemistry analyzers. This in vitro diagnostic device is for prescription use only. The Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/ Mass Spectrometry (GC-MS) or Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
Device Story
Homogeneous enzyme immunoassay for qualitative detection of meprobamate in human urine; utilizes competition between carisoprodol-labeled G6PDH enzyme and free meprobamate in sample for fixed sheep anti-carisoprodol antibody binding sites. In absence of drug, antibody binds conjugate, inhibiting enzyme activity; dose-response relationship established between drug concentration and enzyme activity. G6PDH activity measured spectrophotometrically at 340 nm via conversion of NAD to NADH. Used in clinical laboratories on automated analyzers (e.g., Olympus AU400e) by trained personnel. Provides preliminary analytical result; requires confirmation by GC-MS or LC-MS/MS. Assists clinicians in identifying potential carisoprodol/meprobamate presence in urine samples for toxicology screening.
Clinical Evidence
Bench testing only. Precision/cutoff characterization performed over 10 days (N=80 per concentration) using three lots. Method comparison study analyzed 167 clinical urine samples against LC-MS/MS; demonstrated 100% positive agreement and 92% negative agreement. Specificity/interference testing evaluated structurally related and unrelated compounds; boric acid (1% w/v) identified as causing false negatives. Pharmacokinetic study data supported the clinical validity of the 280 ng/mL cutoff.
Technological Characteristics
Homogeneous enzyme immunoassay; G6PDH enzyme label; sheep anti-carisoprodol polyclonal antibodies. Spectrophotometric detection at 340 nm. Automated clinical chemistry analyzer platform. Stable for 12 months at 2-8 °C. Traceable to certified standard material verified by GC-MS/LC-MS/MS.
Indications for Use
Indicated for the qualitative detection of carisoprodol metabolite (meprobamate) in human urine at a 280 ng/mL cutoff. Intended for use in clinical laboratories using automated chemistry analyzers. Prescription use only.
Regulatory Classification
Identification
A meprobamate test system is a device intended to measure meprobamate in human specimens. Measurements obtained by this device are used to detect the presence of meprobamate to diagnose the use or overdose of meprobamate or structurally-related drug compounds (e.g., prodrugs).
Special Controls
(b) Classification. Class II (special controls). The special controls for this device are:
- 1) Design verification and validation must include:
- Robust data demonstrating the accuracy of the device when used in the intended (i) specimen matrix. The accuracy data must include a comparison between the meprobamate test system results and meprobamate results that are measured on an FDA-accepted measurement method that is specific and accurate (e.g., gas or liquid chromatography combined with tandem mass spectrometry).
- (ii) Robust analytical data demonstrating the performance characteristics of the device, including, but not limited to, specificity, cross-reactivity to relevant endogenous and exogenous substances, and the reproducibility of analyte detection around the cutoff(s).
- 2) The intended use of the device must not include an indication for use in monitoring therapeutic drug concentrations or informing dosing adjustment decisions.
- 3) Your 21 CFR 809.10 labeling must include the following:
- (i) If indicated for use as a screening test to identify preliminary results for further confirmation, the intended use must state "This assay provides only a preliminary analytical result. A more specific alternative chemical confirmatory method (e.g., gas or liquid chromatography and mass spectrometry) must be used to obtain a confirmed analytical result. Clinical consideration and professional judgment must be exercised with any drug of abuse test, particularly when the preliminary test result is positive."
- (ii) A limiting statement that reads as follows: "This test should not be used to monitor therapeutic drug concentrations or to inform dosing adjustment decisions."
*Classification.* Class II (special controls). The special controls for this device are:(1) Design verification and validation must include:
(i) Robust data demonstrating the accuracy of the device when used in the intended specimen matrix. The accuracy data must include a comparison between the meprobamate test system results and meprobamate results that are measured on an FDA-accepted measurement method that is specific and accurate (e.g., gas or liquid chromatography combined with tandem mass spectrometry).
(ii) Robust analytical data demonstrating the performance characteristics of the device, including, but not limited to, specificity, cross-reactivity to relevant endogenous and exogenous substances, and the reproducibility of analyte detection around the cutoff(s).
(2) The intended use of the device must not include an indication for use in monitoring therapeutic drug concentrations or informing dosing adjustment decisions.
(3) Your 21 CFR 809.10 labeling must include the following:
(i) If indicated for use as a screening test to identify preliminary results for further confirmation, the intended use must state “This assay provides only a preliminary analytical result. A more specific alternative chemical confirmatory method (e.g., gas or liquid chromatography and mass spectrometry) must be used to obtain a confirmed analytical result. Clinical consideration and professional judgment must be exercised with any drug of abuse test, particularly when the preliminary test result is positive.”
(ii) A limiting statement that reads as follows: “This test should not be used to monitor therapeutic drug concentrations or to inform dosing adjustment decisions.”
Predicate Devices
Lin-Zhi Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay, Meprobamate Drugs of Abuse Calibrators and Controls [DEN170010]
Submission Summary (Full Text)
{0}
FDA
U.S. FOOD & DRUG
ADMINISTRATION
# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
ASSAY ONLY
## I Background Information:
A 510(k) Number
k190397
B Applicant
Immunalysis Corporation
C Proprietary and Established Names
Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA
D Regulatory Information
| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| QBK | Class II | 21 CFR 862.3590 - Meprobamate Test System | TX - Clinical Toxicology |
## II Submission/Device Overview:
A Purpose for Submission:
New device
B Measurand:
Carisoprodol metabolite (Meprobamate)
C Type of Test:
Qualitative Immunoassay
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
{1}
III Intended Use/Indications for Use:
A Intended Use(s):
See Indications for Use below.
B Indication(s) for Use:
The Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA is a homogenous enzyme immunoassay for the qualitative analysis of carisoprodol metabolite, Meprobamate, at a cutoff of 280 ng/mL in human urine. The assay is intended for use in laboratories with automated clinical chemistry analyzers. This in vitro diagnostic device is for prescription use only.
The Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/ Mass Spectrometry (GC-MS) or Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
C Special Conditions for Use Statement(s):
Rx - For Prescription Use Only
D Special Instrument Requirements:
Assay performance was established using the Olympus AU400e analyzer.
IV Device/System Characteristics:
A Device Description:
The Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA is based on the competition of carisoprodol labeled enzyme glucose-6-phosphate dehydrogenase (G6PDH) and the free Meprobamate in the urine sample for the fixed amount of sheep anti-carisoprodol antibody binding sites. In the absence of the free Meprobamate in the sample, the antibody binds the drug enzyme conjugate and enzyme activity is inhibited. This creates a dose response relationship between drug concentration in the urine and enzyme activity. The enzyme G6PDH activity is determined at 340 nm spectrophotometrically by the conversion of nicotinamide adenine dinucleotide (NAD) to NADH.
B Principle of Operation:
The Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA is based on the competition of carisoprodol labeled enzyme glucose-6-phosphate dehydrogenase (G6PDH) and the free drug in the urine sample for the fixed amount of sheep anti-carisoprodol antibody binding sites. In the absence of the free drug in the sample, the antibody binds the drug enzyme conjugate and enzyme activity is inhibited. This creates a dose response relationship between drug concentration in the urine and enzyme activity. The enzyme G6PDH activity is determined
K190397 - Page 2 of 9
{2}
at 340 nm spectrophotometrically by the conversion of nicotinamide adenine dinucleotide (NAD) to NADH.
## V Substantial Equivalence Information:
A Predicate Device Name(s):
LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay
B Predicate 510(k) Number(s):
DEN170010
C Comparison with Predicate(s):
| Device & Predicate Device(s): | k190397 | DEN170010 |
| --- | --- | --- |
| Device Trade Name | Immunalysis
Carisoprodol
Metabolite /
Meprobamate Urine
HEIA | LZI Carisoprodol
Metabolite
(Meprobamate) Enzyme
Immunoassay |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | For the analysis of carisoprodol metabolite (meprobamate) in human urine. | Same |
| Test Principle | Homogeneous Enzyme Immunoassay | Same |
| User Environment | Laboratory Use | Same |
| Sample Matrix | Human Urine | Same |
| Mass spectrometry confirmation | Required to confirm preliminary positive analytical results | Same |
| General Device Characteristic Differences | | |
| Calibrator material | Carisoprodol | Meprobamate |
| Antibody | Polyclonal sheep antibodies to carisoprodol | Monoclonal mouse antibodies to meprobamate |
## VI Standards/Guidance Documents Referenced:
The sponsor satisfied all special controls as outlined in 21 CFR 862.3590.
K190397 - Page 3 of 9
{3}
VII Performance Characteristics (if/when applicable):
A Analytical Performance:
1. Precision/Reproducibility:
The following laboratory performance studies were performed to determine substantial equivalence of the Immunalysis Carisoprodol Urine HEIA to the predicate device.
Precision/ Cutoff Characterization
A precision/Cutoff Characterization study for meprobamate was performed for ten days using three product lots with two runs per day in replicates of four on drug free urine (N=80) spiked with meprobamate to concentrations of the equivalent of the meprobamate cutoff and ±25%, ±50%, ±75%, and ±100% of the cutoff. The spiked concentrations were confirmed by Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS). The study verified that the cutoff serves as a boundary between a negative and positive interpretation of a qualitative result.
Precision test results in qualitative mode are presented in the table below:
| Meprobamate Concentration (ng/mL) | % of Cutoff | Sample Size | Result | | |
| --- | --- | --- | --- | --- | --- |
| | | | Lot 1 | Lot 2 | Lot 3 |
| 0 | -100% | 80 | 80 Negative | 80 Negative | 80 Negative |
| 70 | -75% | 80 | 80 Negative | 80 Negative | 80 Negative |
| 140 | -50% | 80 | 80 Negative | 80 Negative | 80 Negative |
| 210 | -25% | 80 | 80 Negative | 80 Negative | 80 Negative |
| 280 | Cutoff | 80 | 40 Neg/40 Pos | 38 Neg/42 Pos | 39 Neg/41 Pos |
| 350 | +25% | 80 | 80 Positive | 80 Positive | 80 Positive |
| 420 | +50% | 80 | 80 Positive | 80 Positive | 80 Positive |
| 490 | +75% | 80 | 80 Positive | 80 Positive | 80 Positive |
| 560 | +100% | 80 | 80 Positive | 80 Positive | 80 Positive |
2. Analytical Specificity/Interference:
Specificity and Cross-Reactivity
Compounds that were determined by the sponsor to be structurally and functionally similar to meprobamate were spiked into drug-free urine at levels that will yield a result that is equivalent to the cutoff and were evaluated as potential cross-reactant in the test device. Each compound was evaluated in replicates of four. Each compound was an independent spike and no drug mixes were used.
K190397 - Page 4 of 9
{4}
| Compound | Compound Conc. (ng/mL) | Result | Cross-Reactivity (%) |
| --- | --- | --- | --- |
| Meprobamate | 280 | POS | 100 |
| Carisoprodol | 100 | POS | 280 |
| Buprenorphine | 100,000 | NEG | <0.1% |
| Codeine | 100,000 | NEG | <0.1% |
| Darunavir | 200,000 | NEG | N/D |
| Dihydrocodeine | 100,000 | NEG | <0.1% |
| Efavirenz | 200,000 | NEG | N/D |
| Felbamate | 120,000 | POS | 0.2 |
| Hydrocodone | 100,000 | NEG | <0.1% |
| Hydromorphone | 100,000 | NEG | <0.1% |
| Meperidine | 100,000 | NEG | <0.1% |
| Methocarbamol | 200,000 | NEG | N/D |
| Mitomycin C | 200,000 | NEG | N/D |
| Morphine | 100,000 | NEG | <0.1% |
| Morphine-3-glucuronide | 100,000 | NEG | <0.1% |
| Morphine-6-glucuronide | 100,000 | NEG | <0.1% |
| Naloxone | 100,000 | NEG | <0.1% |
| Naltrexone | 100,000 | NEG | <0.1% |
| Neostigmine | 200,000 | NEG | N/D |
| Norbuprenorphine | 100,000 | NEG | <0.1% |
| Norcodeine | 100,000 | NEG | <0.1% |
| Normorphine | 100,000 | NEG | <0.1% |
| Oxycodone | 100,000 | NEG | <0.1% |
| Oxymorphone | 100,000 | NEG | <0.1% |
| Propoxyphene | 100,000 | NEG | <0.1% |
| Retigabine | 200,000 | NEG | N/D |
| Ritonavir | 200,000 | NEG | N/D |
| Rivastigmine | 200,000 | NEG | N/D |
| Tramadol | 100,000 | NEG | <0.1% |
| Trazadone | 100,000 | NEG | <0.1% |
| Venlafaxine | 100,000 | NEG | <0.1% |
| Zafirlukast | 200,000 | NEG | N/D |
## Interference – Structurally Unrelated Compounds
Structurally unrelated compounds were evaluated by spiking the potential interferent at concentrations of at least $50~\mu \mathrm{g / mL}$ into drug free urine containing analyte at $\pm 25\%$ of the cutoff. The levels of structurally unrelated compounds that did not interfere in the assay are presented in the table below.
K190397 - Page 5 of 9
{5}
K190397 - Page 6 of 9
| Compounds for which interference with the assay was not detected | | |
| --- | --- | --- |
| 4-Bromo-2,5,Dimethoxyphenethylamine | Dehydronorketamine | Naproxen |
| Acetaminophen | Delta-9-THC | Nitrazepam |
| Acetylsalicylic Acid | Doxepin | 11-nor-9 carboxy THC |
| 6-Acetylcodeine | Doxylamine | Nordiazepam |
| Alphenal | Ecgonine | Norketamine |
| 6-Acetylmorphine | Ecgonine methyl ester | Norpropoxyphene |
| Alprazolam | EDDP | Norpseudoephedrine |
| 7-Aminoclonazepam | EMDP | Nortriptyline |
| 7-Aminoflunitrazepam | 1R,2S(-)-Ephedrine | O-desmethyl tramadol |
| 7-Aminonitrazepam | 1S,2R(+)-Ephedrine | O-desmethyl venlafaxine |
| Amitriptyline | Ethyl glucuronide | Olanzapine |
| Amobarbital | Ethylmorphine | Oxazepam |
| S-(+)-Amphetamine | Fenfluramine | PCP |
| Aprobarbital | Fentanyl | Pentobarbital |
| Barbital | Flunitrazepam | Pentazocine |
| Benzoylecgonine | Fluoxetine | Phenazepam |
| Benzylpiperazine | Flurazepam | Phenobarbital |
| Bromazepam | Haloperidol | Phentermine |
| Bupropion | Heroin | Phenylephedrine |
| Butabarbital | Hexobarbital | Phenytoin |
| Butalbital | 11-hydroxy-delta-9-THC | Phenylpropanolamine |
| Caffeine | Ibuprofen | PMA |
| Cannabidiol | Imipramine | Prazepam |
| Cannabinol | Ketamine | Propranolol |
| Carbamazepine | Labetalol | Protriptyline |
| Chlordiazepoxide | Lamotrigine | R,R(-)-Pseudoephedrine |
| Chlorpromazine | Levorphanol tartrate | S,S(+)-Pseudoephedrine |
| cis-Tramadol | Lidocaine | Ritalinic Acid |
| Clobazam | Lorazepam | Salicylic Acid |
| Clomipramine | Lorazepam Glucuronide | Secobarbital |
| Clonazepam | Lormetazepam | Sertraline |
| Clozapine | LSD | Sufentanil Citrate |
| Cocaine | Maprotiline | Talbutal |
| Cotinine | MDA | Tapentadol |
| Cyclobenzaprine | MDEA | Temazepam |
| Cyclopentobarbital | MDMA | Theophylline |
| Demoxepam | S(+)-Methamphetamine | Thiopental |
| Desakylflurazepam | Methadone | Thioridazine |
| Desipramine | Methaqualone | Triazolam |
| Dextromethorphan | Methoxetamine | Trifluoromethylphenyl-piperazine |
| Diazepam | Methylone | Trimipramine |
{6}
| Compounds for which interference with the assay was not detected | | |
| --- | --- | --- |
| Digoxin | Methylphenidate | Verapamil |
| Diphenhydramine | Midazolam | Zolpidem Tartrate |
## Interference – Endogenous Compounds
Endogenous compounds and urine preservatives were evaluated by spiking the potential interferent into drug free urine containing meprobamate at ±25% of the cutoff. Due to the interference of boric acid observed at ±25% of the cutoff, potential interference was also evaluated at ±50% of the cutoff. Other than boric acid, assay performance was not affected by all the other internally existing physiological conditions tested. Endogenous compounds tested that did not interfere in the assay are presented in the table below.
| Acetone | 1.0 g/dL |
| --- | --- |
| Ascorbic Acid | 1.5 g/dL |
| Bilirubin | 0.002 g/dL |
| Creatinine | 0.5 g/dL |
| Ethanol | 1.0 g/dL |
| Galactose | 0.01 g/dL |
| γ-Globulin | 0.5 g/dL |
| Glucose | 2.0 g/dL |
| Hemoglobulin | 0.300 g/dL |
| Human Serum Albumin | 0.5 g/dL |
| Oxalic Acid | 0.1 g/dL |
| Riboflavin | 0.0075 g/dL |
| Sodium Azide | 1% w/v |
| Sodium Chloride | 6.0 g/dL |
| Sodium Fluoride | 1% w/v |
| Urea | 6.0 g/dL |
Boric acid interference test results are presented in the table below.
| Interferent | -50% Cutoff (50 ng/mL) Result | +50% Cutoff (150 ng/mL) Result |
| --- | --- | --- |
| Boric Acid (1%w/v) | Negative | Negative |
Boric Acid at 1% w/v may cause false negative results. The assay should not be used to test samples which contain boric acid.
## 3. Assay Reportable Range:
Not applicable. This device is intended for qualitative use only.
K190397 - Page 7 of 9
{7}
4. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):
The device is traceable to a commercially available, certified, standard material for which the concentration is verified by GC-MS or LC-MS/MS.
Accelerated stability and real time studies have been conducted for the device. Protocols and acceptance criteria were described and found to be acceptable. The manufacturer claims that when stored un-opened at 2-8 °C, the device is stable for 12 months.
5. Detection Limit:
See Precision/Reproducibility section in XII.A.1, above.
6. Assay Cut-Off:
Characterization of how the device performs analytically around the claimed cut-off concentration appears in the precision section, VII.A.1, above.
B Comparison Studies:
1. Method Comparison with Predicate Device:
One hundred and sixty-seven (167) de-identified, unaltered leftover clinical urine samples obtained from clinical testing laboratories were analyzed for total carisoprodol at an assay cutoff of 280 ng/mL with the Immunalysis Carisoprodol Urine HEIA on the Olympus AU400e compared to results by Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS). Method comparison results are presented in the tables below.
| Immunalysis Meprobamate Urine HEIA Result | LC-MS/MS Total Meprobamate Concentration | | | | Agreement (%) |
| --- | --- | --- | --- | --- | --- |
| | < 140 ng/mL (less than -50% cutoff) | 140-279 ng/mL (between - 50% cutoff and cutoff) | 280-420 ng/mL (between cutoff and +50% cutoff) | > 420 ng/mL (greater than +50% cutoff) | |
| Positive | 3 | 2 | 3 | 104 | 100% (107/107) |
| Negative | 51 | 4 | 0 | 0 | 92% (55/60) |
Results from this testing included three false positive samples with meprobamate concentrations less than 50% of the cutoff. It was determined in LC-MS/MS testing that each of these samples included carisoprodol, as described in the table below, which caused the positive device results.
| Sample ID | Qualitative Result | Carisoprodol (ng/mL) |
| --- | --- | --- |
| 17990 | POS | 147 |
| 17977 | POS | 148 |
K190397 - Page 8 of 9
{8}
K190397 - Page 9 of 9
18077 | POS | 750
2. **Matrix Comparison:**
Not applicable. Urine is the only claimed matrix for the candidate device.
**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):**
To support their proposed cutoff of 280 ng/mL for detection of the carisoprodol metabolite meprobamate, the sponsor provided protocols for and results from a pharmacokinetic study. Urine samples in this study were evaluated both by the sponsor’s device as well as confirmatory LC-MS/MS testing. After review, it was determined that the sponsor’s proposed cutoff was clinically valid for the intended use of the device.
**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.
Predicate graph will load when search results are available.
Embedding visualization will load when search results are available.
PDF viewer will load when search results are available.
Loading panels...
Select an item from Submissions
Click any panel, subpart, regulation, product code, or device to see details here.
Section Matches
Results will appear here.
Product Code Matches
Results will appear here.
Special Control Matches
Results will appear here.
Loading collections...
Loading
My Alerts
You will receive email notifications based on the filters and frequency you set for each alert.
Sort by:
Create Alert
Search Filters
Agent Token
Create a read-only bearer token for Claude, ChatGPT, or other agents that can call HTTP APIs.
Copy this now. It will not be shown again.
Connected apps
Apps you authorized through browser sign-in. Disconnecting revokes their access immediately.
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.
