This device is a qualitative immunoassay intended to detect buprenorphine (BUP) and its metabolite, norbuprenorphine (NBUP) in human urine. Results are preliminary positive when the combination of the concentrations of BUP and NBUP is greater than 10 ng/ml. It is for health care professional use only. This test provides only a preliminary 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 High Performance Liquid Chromatography (HPLC) 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 obtained.
Device Story
Lateral flow chromatographic immunoassay; detects buprenorphine and norbuprenorphine in human urine. Input: urine specimen; test strip contains conjugate pad with colloidal gold-labeled rabbit anti-buprenorphine antibodies and mouse IgG; nitrocellulose membrane with test line (Buprenorphine-BSA) and control line (goat anti-mouse IgG). Operation: specimen migrates via capillary action; competitive binding occurs; visual appearance of lines indicates presence or absence of drug. Output: qualitative visual result (preliminary positive if combined BUP/NBUP > 10 ng/ml). Used in clinical settings (physician offices, reference labs) by healthcare professionals. Results require confirmation via GC/MS or HPLC. Assists clinicians in identifying potential drug abuse; supports clinical decision-making.
Clinical Evidence
Clinical study of 94 specimens (54 confirmed positive via HPLC/MS or GC/MS, 40 drug-free). Overall agreement with reference methods was 96.8%. Sensitivity 96.3%, specificity 97.3%. Reproducibility study across three sites (two physician offices, one reference lab) showed 97.1% agreement for BUP and 98.4% for NBUP. Interference studies confirmed no impact from urine pH (3.0-9.0) or specific gravity (1.002-1.035).
Indicated for the qualitative detection of buprenorphine and its metabolite, norbuprenorphine, in human urine specimens for healthcare professional use. Used for preliminary screening of drug abuse.
Regulatory Classification
Identification
An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.
Special Controls
*Classification.* Class II (special controls). An opiate test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
Predicate Devices
OneStep Buprenorphine Test, New Bay Bioresearch, Co. Ltd.
Submission Summary (Full Text)
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE
A. 510(k) Number:
k060527
B. Purpose for Submission:
Clearance of a new device.
C. Measurand:
Buprenorphine and Norbuprenorphine
D. Type of Test:
Qualitative, visually read, immunochromatographic test
E. Applicant:
Alfa Scientific Designs, Inc.
F. Proprietary and Established Names:
Instant-View, Instant-Confirmatory, or Instant-Confirmatory
Buprenorphine/Norbuprenorphine Urine Test (Cassette and Dip-Strip)
G. Regulatory Information:
1. Regulation section:
21 CFR §862.3650, Opiate Test System
2. Classification:
Class II
3. Product code:
DJG
4. Panel:
Toxicology (91)
H. Intended Use:
1. Intended use(s):
This device is a qualitative immunoassay intended to detect buprenorphine (BUP) and its metabolite, norbuprenorphine (NBUP) in human urine. Results are preliminary positive when the combination of the concentrations of BUP and NBUP is greater than 10 ng/ml. It is for health care professional use only.
This test provides only a preliminary 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 High Performance Liquid Chromatography (HPLC) 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 obtained.
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2. Indication(s) for use:
See Intended Use above.
3. Special conditions for use statement(s):
A positive test result does not always mean an individual has taken the drug illegally as the drug can be administered legally.
4. Special instrument requirements:
Not applicable. The device is a visually read single-use device.
I. Device Description:
This assay is a one-step lateral flow chromatographic immunoassay. The test strip consists of 1) a burgundy-colored conjugate pad containing rabbit anti-buprenorphine antibodies and mouse IgG coupled to colloidal gold; and 2) a nitrocellulose membrane containing a Test (T) line and a Control (C) line. The T line is coated with buprenorphine-BSA, and the C line is coated with goat anti-mouse IgG antibody.
This test is a competitive binding immunoassay. The buprenorphine and norbuprenorphine in the urine specimen competes with the buprenorphine-BSA antigen coated on the nitrocellulose membrane for the limited binding sites of the conjugated anti-buprenorphine antibodies.
When an adequate amount of urine specimen is applied to the sample pad of the device, the urine specimen migrates by capillary action through the test strip. If the level of buprenorphine and / or norbuprenorphine in the urine specimen is below the cutoff concentration (10 ng/ml), the T line appears as a visible burgundy line. If the level of buprenorphine in the urine specimen is above the cutoff, no T line develops.
The C line will bind to the mouse IgG conjugate and form a burgundy color band regardless of the presence of buprenorphine. The C line serves as an internal qualitative control of the test system.
J. Substantial Equivalence Information:
1. Predicate device name(s):
OneStep Buprenorphine Test
2. Predicate 510(k) number(s):
k042988
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3. Comparison with predicate:
| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Sample Types | Urine | Urine |
| Test Method | Immunochromatographic | Immunochromatographic |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | Qualitative immunoassay intended to detect buprenorphine (BUP) and its metabolite, norbuprenorphine (NBUP) in human urine. | Qualitative immunoassay intended to detect buprenorphine (BUP) in human urine. |
| Cutoff | BUP+NBUP: 10 ng/mL | BUP: 10 ng/mL |
| Major Cross Reactors: | Detects BUP and NBUP equally | Detects BUP glucuronide metabolite at 2.5 ng/mL |
K. Standard/Guidance Document Referenced (if applicable):
None were identified by the applicant.
L. Test Principle:
See Section I., Device Description, above.
M. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
Reproducibility was evaluated at three POL locations. Eighty-pooled drug-free human urine specimens were spiked with buprenorphine or norbuprenorphine at different levels. All specimens were blind labeled and tested. Results are summarized in the table below.
| Buprenorphine | | Site I | Site II | Site III | Expected Result |
| --- | --- | --- | --- | --- | --- |
| Controls | 0 ng/ml | 10 - | 10 - | 10 - | 10 - |
| | 5 ng/ml | 15- | 15- | 15- | 15- |
| | 7.5 ng/ml | 14-, 1+ | 14-, 1+ | 14-, 1+ | 15- |
| | 12.5 ng/ml | 14+, 1- | 13+, 2- | 14+, 1- | 15+ |
| | 15 ng/ml | 15+ | 15+ | 15+ | 15+ |
| | 30 ng/ml | 10+ | 10+ | 10+ | 10+ |
| Agreement | Site | 96.3% | 96.3% | 97.5% | |
| | Average | 97.1% | | | |
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| Norbuprenorphine | | Site I | Site II | Site III | Expected Result |
| --- | --- | --- | --- | --- | --- |
| Controls | 0 ng/ml | 10 - | 10 - | 10 - | 10 - |
| | 5 ng/ml | 15- | 15- | 15- | 15- |
| | 7.5 ng/ml | 14-, 1+ | 13-, 2+ | 14-, 1+ | 15- |
| | 12.5 ng/ml | 15+ | 15+ | 15+ | 15+ |
| | 15 ng/ml | 15+ | 15+ | 15+ | 15+ |
| | 30 ng/ml | 10+ | 10+ | 10+ | 10+ |
| Agreement | Site | 98.8% | 97.5% | 98.8% | |
| | Average | 98.4% | | | |
b. Linearity/assay reportable range:
Not applicable. This is a semi-quantitative device; a ‘positive’ result only suggests that buprenorphine is present in quantities above the cutoff level.
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
This test contains a built-in control feature, the C line. The appearance of the burgundy C line indicates an adequate volume of specimen has been absorbed and the capillary flow through the test strip has occurred. The C line should always appear. If the Control line does not develop within 5 minutes, the sponsor suggests reviewing the entire procedure and repeating the test with a new device.
The sponsor also recommends that users follow appropriate federal, state, and local guidelines concerning the running of external quality controls.
d. Detection limit:
Sensitivity of qualitative assays may be characterized by validating performance around the claimed cutoff concentration of the assay, and demonstrating the lowest concentration of drug that is capable of or consistently producing a positive result. This information appears the Precision/Reproducibility section above.
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# e. Analytical specificity:
# Cross-Reactivity
To evaluate the cross-reactivity of the device, compounds structurally related to buprenorphine were studied. The lowest concentration of the drugs producing a positive response equivalent to the cutoff level of the device was listed in the table below.
| Compounds Name | Concentration (ng/ml) |
| --- | --- |
| Buprenorphine | 10 |
| Norbuprenorphine | 10 |
| Buprenorphine-3-β-D-glucuronide | 750 |
| Norbuprenorphine-3-β-D-glucuronide | 30,000 |
| Nalorphine | 100,000 |
# Interfering Substances
The following substances, evaluated separately, were spiked with $100\mu \mathrm{g / ml}$ of the substance and evaluated in urine pools containing combined concentrations of buprenorphine and norbuprenorphine at 0 and $15\mathrm{ng / ml}$ . No interference was observed from those analytes at the concentration listed in the following tables.
| Acetaminophen | Cortisone |
| --- | --- |
| Acetylsalicylic Acid | Dextromethorphan |
| Amikacin | Ethanol |
| Amitriptyline | Lidocaine |
| Ampicillin | Methadone |
| Arterenal | Methanol |
| Aspirin | Oxalic Acid |
| Benzoic Acid | Penicillin-G (Benzylpenicillin) |
| Benzoylecgonine | β-phenylthylamine |
| Caffeine | Phenylpropanalamine |
| (+)-Chlorpheniramine | Ranitidine |
| (+/-)-Chlorpheniramine | Salicyclic Acid |
| Cocaine | Thioridazine |
The following endogenous substances, tested the same as the above substances, were tested and confirmed not to interfere with the BUP/NBUP test device at listed concentration.
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| Biological Analytes | Concentration |
| --- | --- |
| Albumin(serum) | 2,000 μg/ml |
| Bilirubin | 1,000 μg/ml |
| Creatine | 1,000 μg/ml |
| Hemoglobin | 1,000 μg/ml |
| Glucose | 2,000 μg/ml |
| Vitamin C (L-Ascorbic Acid) | 1,000 μg/ml |
| Uric Acid | 1,000 μg/ml |
| pH | 5.0-9.0 |
f. Assay cut-off:
The stated cutoff of this assay is 10 ng/mL. Characterization of how the device performs analytically around the claimed cutoff concentration appears in the Detection limit section, above. The Substance Abuse and Mental Health Services Administration (SAMHSA) has not recommended cutoff levels for buprenorphine tests.
2. Comparison studies:
a. Method comparison with predicate device:
The accuracy of this device was evaluated using 54 clinical urine specimens and 40 drug free urine samples with varying un-hydrolyzed concentrations of both buprenorphine and norbuprenorphine in different ratios, each blind-labeled. The results from this test device agreed 100% with the HPLC/MS and GC/MS on the non-hydrolyzed specimens at levels below 75% of the cutoff (negative) and above 125% of the cutoff (positive). Three (3) discrepancies were observed on the specimens of buprenorphine/norbuprenorphine at the level between 75% and 125% of the cutoff. The overall agreement was 96.8% (3 discrepancies/94 specimens).
| Buprenorphine/Norbuprenorphine | BUP and NBUP | | Total | Agreement | |
| --- | --- | --- | --- | --- | --- |
| | | Positive | | | Negative |
| HPLC/MS (ng/ml) | Negative (<75%) | 0 | 49 | 49 | 100% |
| | 75%-Cutoff | 1* | 5 | 6 | 83.3% |
| | Cutoff-125% | 18 | 2* | 20 | 90% |
| | Positive (>12.5) | 19 | 0 | 19 | 100% |
| Total | | 38 | 56 | 94 | |
* indicates discrepancy.
b. Matrix comparison:
Not applicable.
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3. Clinical studies:
a. Clinical Sensitivity: Not applicable.
b. Clinical specificity: Not applicable.
c. Other clinical supportive data (when a. and b. are not applicable): Not applicable.
4. Clinical cut-off: Not applicable.
5. Expected values/Reference range: No elicit drugs should be present in urine.
N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
O. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
7
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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.
