K071489 · Tianjin New Bay Bioresearch Co., Ltd. · DKZ · Mar 28, 2008 · Clinical Toxicology
Device Facts
Record ID
K071489
Device Name
HOMECHECK MULTIPLE DRUG CUP TEST
Applicant
Tianjin New Bay Bioresearch Co., Ltd.
Product Code
DKZ · Clinical Toxicology
Decision Date
Mar 28, 2008
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 862.3100
Device Class
Class 2
Indications for Use
The assay provides a simple and rapid analytical screening procedure to detect single or multiple different abused drugs (Amphetamine, Methamphetamine, Benzoylecgonine, Benzodiazepine, Marijuana, Morphine, Phencyclidine, Methadone, Oxycodone, Tricyclic Antidepressant, and Barbiturates in human urine. The assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography /mass spectrometry (GC/MS) is the preferred confirmatory method. HPLC is preferred confirmatory method for Tricyclic Antidepressant. This test is intended for over the counter (OTC) consumer use as the first step in a 2-step process to provide consumers with information concerning the presence or absence of the above stated drugs in a urine sample. Information regarding the confirmatory testing - the second step in the process-, along with materials for shipping the urine specimen to the laboratory is included with the test. There are no uniformly recognized levels for Benzodiazepine, Oxycodone, Tricyclic Antidepressant, and Barbiturates. The test is not intended to screen individuals who are prescribed these drugs by a physician; the test my yield positive results for individuals taking such drugs, as prescribed.
Device Story
HomeCheck™ Multiple Drug Cup Test; lateral flow immunoassay for qualitative drug screening in human urine. Input: urine sample collected in cup. Operation: colloidal gold-labeled antibody-conjugate binds to free drug in specimen; complex competes with immobilized antigen on absorbent strip. Output: visual color bands on test strips; absence of band indicates drug presence above cutoff. Used in home setting by lay users. Preliminary positive results require confirmatory testing via GC/MS or HPLC; shipping materials for laboratory confirmation included. Benefits: provides consumers with rapid information regarding presence/absence of drugs; facilitates access to professional confirmatory testing.
Clinical Evidence
No clinical data provided. Substantial equivalence is based on bench testing comparing the subject device to the predicate device and analytical performance verification.
Technological Characteristics
Lateral flow immunochromatographic assay; colloidal gold-labeled antibody conjugate; porous membrane support. Visual read, single-use test cup. No instrumentation, electronics, or software. Storage below 28°C.
Indications for Use
Indicated for OTC qualitative screening of Amphetamine, Methamphetamine, Benzoylecgonine, Benzodiazepine, Marijuana, Morphine, Phencyclidine, Methadone, Oxycodone, Tricyclic Antidepressant, and Barbiturates in human urine. Not intended for screening individuals prescribed these medications by a physician.
Regulatory Classification
Identification
An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.
Special Controls
*Classification.* Class II (special controls). An amphetamine 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
Tianjin New Bay Forsure Rapid One Step Multiple(X) Abuse Drug Screen Test (k052882)
Submission Summary (Full Text)
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1
# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE
A. 510(k) Number:
k071489
B. Purpose for Submission:
Previously cleared prescription use device expanding for over-the-counter (OTC) use
C. Measurand:
methamphetamine, amphetamine, opiates, cocaine, tetrahydrocannabinol, phencyclidine, barbiturates, benzodiazepines, oxycodone, tricyclic antidepressants, methadone
D. Type of Test:
qualitative, immunoassay, lateral flow
E. Applicant:
Tianjin, New Bay Bioresearch Company Limited
F. Proprietary and Established Names:
HomeCheck™ Multiple Drug Cup Test
G. Regulatory Information:
1. Regulation section:
862.3100, Amphetamine Test System
862.3150, Barbiturate Test System
862.3170, Benzodiazepine Test System
862.3870, Cannabinoids Test System
862.3250, Cocaine and Cocaine Metabolite Test System
862.3620, Methadone Test System
862.3610, Methamphetamine Test System
862.3650, Opiates and Oxycodone Test System
Unclassified, Enzyme Immunoassay, Phencyclidine
2. Classification:
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Class II
3. Product code:
DKZ, DIS, JXM, LDJ, DIO, DJC, DJR, DJG, LCM, LFH
4. Panel:
91, Toxicology
H. Intended Use:
1. Intended use(s):
HomeCheck™ Multiple Drug cup test device for Amphetamine (cutoff at 1000ng/ml), Methamphetamine (cutoff at 1000ng/ml), Benzoylecgonine (cutoff at 300ng/ml), Benzodiazepine (cutoff at 300ng/ml for Oxazepam), Marijuana (cutoff at 50ng/ml), Morphine (cutoff at 2000ng/ml), Phencyclidine (cutoff at 25ng/ml), Methadone (cutoff at 300ng/ml), Oxycodone (cutoff at 100ng/ml), Tricyclic Antidepressant (cutoff at 1000 ng/ml for Nortriptyline HCl), and Barbiturates (cutoff at 300ng/ml for Secobarbital).
2. Indication(s) for use:
The assay provides a simple and rapid analytical screening procedure to detect single or multiple different abused drugs (Amphetamine, Methamphetamine, Benzoylecgonine, Benzodiazepine, Marijuana, Morphine, Phencyclidine, Methadone, Oxycodone, Tricyclic Antidepressant, and Barbiturates in human urine.
The assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography /mass spectrometry (GC/MS) is the preferred confirmatory method. HPLC is preferred confirmatory method for Tricyclic Antidepressant.
3. Special conditions for use statement(s):
This test is intended for over the counter (OTC) consumer use as the first step in a 2-step process to provide consumers with information concerning the presence or absence of the above stated drugs in a urine sample. Information regarding the confirmatory testing - the second step in the process-, along with materials for shipping the urine specimen to the laboratory is included with the test. There are no uniformly recognized levels for Benzodiazepine, Oxycodone, Tricyclic Antidepressant, and Barbiturates. The test is not intended to screen individuals who are prescribed these drugs by a physician; the test may yield positive results for individuals taking such drugs, as prescribed.
4. Special instrument requirements:
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None
I. Device Description:
The test consists of chromatographic absorbent strips inserted within a sample collection cup and home use labeling with supplies and instructions for obtaining laboratory confirmation for preliminary positive results (at no additional cost).
J. Substantial Equivalence Information:
1. Predicate device name(s):
Tianjin New Bay Forsure Rapid One Step Multiple(X) Abuse Drug Screen Test
2. Predicate K number(s):
k052882
3. Comparison with predicate:
The new device is for home use; the predicate device is for prescription use. Therefore, the new device provides users with additional instructions and supplies for obtaining confirmation. The physical device is the same as the predicate except that the home use device does not include propoxyphene, which is present on the professional use device.
K. Standard/Guidance Document Referenced (if applicable):
None were referenced.
L. Test Principle:
As the test sample flows through the absorbent strip, the colloidal gold labeled antibody-conjugate binds to the free drug in the specimen forming an antibody-antigen complex. This complex competes with immobilized antigen conjugate in the Test reaction zone, with the result that no color band is produced if there is drug in the sample above the detection levels (stated in the intended use). In addition, unbound colloidal gold-labeled antibody conjugate binds to the reagent in the negative control zone, producing a color band, to indicate that sufficient sample was added.
M. Performance Characteristics (if/when applicable):
1. Analytical performance:
All analytical performance characteristics were reviewed previously under k(052882). See http://www.fda.gov/cdrh/reviews/k052882.pdf. Therefore this current 510(k) submission includes the lay user study only. See 3.c. "other
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clinical supportive data”, below, for results of the lay-user study.
a. Precision/Reproducibility:
b. Linearity/assay reportable range:
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
d. Detection limit:
e. Analytical specificity:
f. Assay cut-off: The identified cutoff concentrations for amphetamine, cocaine, methamphetamine, opiates 2000, Phencyclidine and THC are those recommended by the Substance Abuse and Mental Health Services Administration (SAMHSA). The SAMHSA has not recommended a cutoff concentration for Barbiturate, Benzodiazepine, Oxycodone, and Tricyclic Antidepressant (TCA). Characterization of how the device performs analytically around the claimed cutoff concentration appears in the precision and detection limit sections for the predicate (k052882). See http://www.fda.gov/cdrh/reviews/k052882.pdf
2. Comparison studies:
a. Method comparison with predicate device:
See 3.c., below
b. Matrix comparison:
Not applicable. The test is only for urine specimens.
3. Clinical studies:
a. Clinical Sensitivity:
Not typically reviewed for this device type.
b. Clinical specificity:
Not typically reviewed for this device type.
c. Other clinical supportive data (when a. and b. are not applicable): The HomeCheck One Step Drug Cup Screen test was performed and interpreted by 103 lay users using spiked, masked, urine samples.
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Volunteers were selected as they presented themselves at the participating U.S. site. Participants represented diversity in age (20-72), gender (75% male), education (7% non-high school graduates; 69% high school graduates; 21% some college education; 6% post-graduate or technical) and occupation.
Each participant performed one multiple drug cup test using a spiked masked urine sample. Each sample contained a combination of drugs (4-6 drugs) at varying concentrations above and below the cutoff concentration. Drug concentrations in the samples included low negative, 50% below the cutoff, 25% below the cutoff, 25% above, 50% above, and high positive for each drug. Each participant performed the test independently using the proposed labeling, with no additional instructions, and recorded results for all 11 drugs in the test. After testing, the participants also answered questions to help evaluate whether the tests could be performed and interpreted by lay users. Test results are tabulated below compared to results of GCMS (and HPLC for TCA) for each drug.
Results for amphetamines:
| HomeCheck Test Results By Lay User | GC/MS Test Results | | | | | | | % Agreement with GC/ Mass | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | Low Negative | 50% below Cutoff | 25% Below Cutoff | Cutoff | 25 % Above Cutoff | 50 % Above Cutoff | High Positive | Negative | Positive |
| AMP | Positive | 0 | 0 | 2 | 6 | 13 | 13 | 13 | 96.6 | 100 |
| | Negative | 29 | 15 | 12 | 0 | 0 | 0 | 0 | | |
Results for barbiturates
| HomeCheck Test Results By Lay User | GC/MS Test Results | | | | | | | % Agreement with GC/ Mass | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | Low Negative | 50% below Cutoff | 25% Below Cutoff | Cutoff | 25 % Above Cutoff | 50 % Above Cutoff | High Positive | Negative | Positive |
| BAR | Positive | 0 | 0 | 2 | 12 | 13 | 14 | 15 | 95.8 | 98.2 |
| | Negative | 29 | 6 | 11 | 1 | 0 | 0 | 0 | | |
Results for benzodiazepine :
| HomeCheck Test Results By Lay User | GC/MS Test Results | | | | | | | % Agreement with GC/ Mass | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | Low Negative | 50% below Cutoff | 25% Below Cutoff | Cutoff | 25 % Above Cutoff | 50 % Above Cutoff | High Positive | Negative | Positive |
| BZD | Positive | 0 | 0 | 1 | 14 | 15 | 14 | 6 | 98.1 | 98 |
| | Negative | 26 | 13 | 13 | 1 | 0 | 0 | 0 | | |
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Results for benzoylecgonine:
| HomeCheck Test Results By Lay User | GC/MS Test Results | | | | | | | % Agreement with GC/ Mass | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | Low Negative | 50% below Cutoff | 25% Below Cutoff | Cutoff | 25 % Above Cutoff | 50 % Above Cutoff | High Positive | Negative | Positive |
| COC | Positive | 0 | 0 | 2 | 6 | 13 | 13 | 13 | 96.6 | 100 |
| | Negative | 29 | 15 | 12 | 0 | 0 | 0 | 0 | | |
Results for methadone
| HomeCheck Test Results By Lay User | GC/MS Test Results | | | | | | | % Agreement with GC/ Mass | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | Low Negative | 50% below Cutoff | 25% Below Cutoff | Cutoff | 25 % Above Cutoff | 50 % Above Cutoff | High Positive | Negative | Positive |
| MAD | Positive | 0 | 0 | 2 | 13 | 6 | 13 | 13 | 96.5 | 97.8 |
| | Negative | 27 | 15 | 15 | 1 | 0 | 0 | 0 | | |
Results for methamphetamine:
| HomeCheck Test Results By Lay User | GC/MS Test Results | | | | | | | % Agreement with GC/ Mass | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | Low Negative | 50% below Cutoff | 25% Below Cutoff | Cutoff | 25 % Above Cutoff | 50 % Above Cutoff | High Positive | Negative | Positive |
| MET | Positive | 0 | 0 | 2 | 13 | 14 | 6 | 13 | 96.4 | 100 |
| | Negative | 26 | 14 | 15 | 0 | 0 | 0 | 0 | | |
Results for morphine:
| HomeCheck Test Results By Lay User | GC/MS Test Results | | | | | | | % Agreement with GC/ Mass | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | Low Negative | 50% below Cutoff | 25% Below Cutoff | Cutoff | 25 % Above Cutoff | 50 % Above Cutoff | High Positive | Negative | Positive |
| OPI | Positive | 0 | 0 | 2 | 13 | 6 | 13 | 13 | 96.5 | 97.8 |
| | Negative | 27 | 15 | 15 | 1 | 0 | 0 | 0 | | |
Results for oxycodone:
| HomeCheck Test Results By Lay User | GC/MS Test Results | | | | | | | % Agreement with GC/ Mass | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | Low Negative | 50% below Cutoff | 25% Below Cutoff | Cutoff | 25 % Above Cutoff | 50 % Above Cutoff | High Positive | Negative | Positive |
| OXY | Positive | 0 | 0 | 1 | 14 | 15 | 15 | 14 | 97.8 | 100 |
| | Negative | 19 | 13 | 12 | 0 | 0 | 0 | 0 | | |
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Results for phencyclidine:
| HomeCheck Test Results By Lay User | GC/MS Test Results | | | | | | | % Agreement with GC/ Mass | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | Low Negative | 50% below Cutoff | 25% Below Cutoff | Cutoff | 25 % Above Cutoff | 50 % Above Cutoff | High Positive | Negative | Positive |
| PCP | Positive | 0 | 0 | 0 | 13 | 13 | 13 | 14 | 100 | 100 |
| | Negative | 30 | 14 | 6 | 0 | 0 | 0 | 0 | | |
Results for tricyclic antidepressants:
| HomeCheck Test Results By Lay User | HPLC Test Results | | | | | | | % Agreement with HPLC | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | Low Negative | 50% below Cutoff | 25% Below Cutoff | Cutoff | 25 % Above Cutoff | 50 % Above Cutoff | High Positive | Negative | Positive |
| TCA | Positive | 0 | 0 | 3 | 13 | 14 | 15 | 15 | 96.4 | 100 |
| | Negative | 20 | 13 | 10 | 0 | 0 | 0 | 0 | | |
Results for THC:
| HomeCheck Test Results By Lay User | GC/MS Test Results | | | | | | | % Agreement with GC/ Mass | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | Low Negative | 50% below Cutoff | 25% Below Cutoff | Cutoff | 25 % Above Cutoff | 50 % Above Cutoff | High Positive | Negative | Positive |
| THC | Positive | 0 | 0 | 2 | 15 | 14 | 6 | 13 | 96.3 | 100 |
| | Negative | 26 | 14 | 13 | 0 | 0 | 0 | 0 | | |
## Participant Procedure Questionnaire:
After testing, participants responded to surveys with questions to help determine whether participants understood test instructions.
These included questions to the participant on whether they had any difficulty running the test, reading it at the appropriate time, seeing the test line, and whether there was anything in the labeling that they found confusing.
Participants were given the opportunity to rate various features of the labeling (clarity, illustration, directions) on a scale of 1-5. Responses indicated that 99-100% of participants felt the test was not difficult to run, read, or interpret, and that labeling was understandable.
Additional questions were included to address test interpretation issues such as test line darkness/faintness, importance of confirmation testing, and possibility for false positives from certain foods or drugs, as well as issues concerning testing and confirmation of prescription drugs. Participant
{7}
responses support that lay user participants generally understood how to run and interpret the screening test, including the importance of confirmation, and some of the issues concerning testing for prescription drugs.
4. Clinical cut-off:
Not applicable
5. Expected values/Reference range:
Not applicable.
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.
8
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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.
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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?
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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.
