ACCU-STAT HOME DRUG TEST FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, OPIATES, AND PHENCYCLIDINE
K040629 · Accu-Stat Diagnostics, Inc. · LDJ · May 5, 2004 · Clinical Toxicology
Device Facts
Record ID
K040629
Device Name
ACCU-STAT HOME DRUG TEST FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, OPIATES, AND PHENCYCLIDINE
Applicant
Accu-Stat Diagnostics, Inc.
Product Code
LDJ · Clinical Toxicology
Decision Date
May 5, 2004
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 862.3870
Device Class
Class 2
Indications for Use
The Accu-Stat™ Home Drug Test for Marijuana (THC), Cocaine (COC), Amphetamine (AMP), Methamphetamine (mAMP), Opiates (OPI), and Phencyclidine (PCP) is a single-unit screening test for the rapid detection of two to six of the above drugs in human urine. The designated cutoff concentrations for these drugs are as follows: Marijuana at 50 ng/ml, Cocaine at 300 ng/ml, Amphetamine at 1000 ng/ml, Methamphetamine at 1000 ng/ml, Opiates at 2000 ng/ml, and Phencyclidine at 25 ng/ml. The tests are intended for over-the-counter (OTC) consumer use as the first step in a two step process that includes confirmatory testing of preliminary positive results. Information, along with the materials for shipping a portion of the urine specimen to the laboratory is provided.
Device Story
Single-use, visually-read lateral flow immunochromatographic cassette; detects drugs of abuse in human urine. User adds urine via plastic dispenser; competitive binding principle: drug-free samples allow antibody-coated particles to bind to immobilized drug-specific conjugate, forming a colored test line; drug-positive samples saturate binding sites, preventing line formation. Procedural control line confirms proper wicking. Intended for OTC consumer use; preliminary results require laboratory confirmation via provided shipping materials. Benefits include rapid, private initial screening for drug presence.
Clinical Evidence
Consumer study (n=503) evaluated accuracy and interpretation. Participants tested urine samples spiked with drugs at 0%, 50%, 75%, 125%, 150%, and 200% of cutoff concentrations. Results showed high correct interpretation rates; all incorrect interpretations occurred within ±25% of the cutoff. No clinical sensitivity/specificity studies were required for this device type.
Technological Characteristics
One-step rapid chromatographic immunoassay; competitive binding principle. Device utilizes antibody-coated particles and immobilized drug conjugates. Form factor: test card/well for urine sample application. No external energy source required; visual readout via colored lines. No software or electronic components.
Indications for Use
Indicated for OTC consumer use for the rapid qualitative detection of two to six drugs (THC, COC, AMP, mAMP, OPI, PCP) in human urine. Intended as a preliminary screening step requiring confirmatory testing via alternative chemical methods (e.g., GC/MS).
Regulatory Classification
Identification
A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds include delta-9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.
Special Controls
*Classification.* Class II (special controls). A cannabinoid 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
First Check® Home Drug Test for Marijuana, Cocaine, Mcthamphetamine, & Opiates (K993852)
Phamatech At Home™ Drug Test for Amphetamine, Methamphetamine (Ecstasy), Marijuana, Cocaine, and Opiates (K003858)
Submission Summary (Full Text)
{0}
510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
DEVICE ONLY TEMPLATE
A. 510(k) Number:
K040629
B. Purpose for Submission:
Remarketing of previously approved product for OTC use
C. Analyte:
Marijuana (THC), Cocaine (COC), Amphetamine (AMP), Methamphetamine (mAMP), Opiates (OPI), and Phencyclidine (PCP)
D. Type of Test:
Qualitative immunoassay
E. Applicant:
Accu-Stat Diagnostics
F. Proprietary and Established Names:
Accu-Stat Home Drug Test for Marijuana (THC), Cocaine (COC), Amphetamine (AMP), Methamphetamine (mAMP), Opiates (OPI), and Phencyclidine (PCP)
G. Regulatory Information:
1. Regulation section:
Unclassified, Test Kit, Multiple Drugs of Abuse, Over the Counter
862.3870, Enzyme Immunoassay, Cannabinoids
862.3250, Enzyme Immunoassay, Cocaine and Cocaine Metabolites
862.3100, Enzyme Immunoassay, Amphetamine
862.3610, Enzyme Immunoassay, Methamphetamine
862.3650, Enzyme Immunoassay, Opiates
Unclassified, Enzyme Immunoassay, Phencyclidine
2. Classification:
Class II
3. Product Code:
MVO, LDJ, DIO, DKZ, LAF, DJG, and LCM respectively
4. Panel:
Toxicology (91)
H. Intended Use:
1. Indication(s) for use:
"The Accu-Stat™ Home Drug Test for Marijuana (THC), Cocaine (COC), Amphetamine (AMP), Methamphetamine (mAMP), Opiates (OPI), and Phencyclidine (PCP) is a single-unit screening test for the rapid detection of
{1}
Page 2 of 4
two to six of the above drugs in human urine. The designated cut-off concentrations for these drugs are as follows: Marijuana at 50 ng/ml, Cocaine at 300 ng/ml, Amphetamine at 1000 ng/ml, Methamphetamine at 1000 ng/ml, Opiates at 2000 ng/ml, and Phencyclidine at 25 ng/ml. The tests are intended for over-the-counter (OTC) consumer use as the first step in a two step process that includes confirmatory testing of preliminary positive results. Information, along with the materials for shipping a portion of the urine specimen to the laboratory is provided.”
2. Special condition for use statement(s):
This device only provides a preliminary analytical test result. A more specific alternative chemical method must be used to obtain confirmed analytical results. Gas chromatography/mass spectroscopy is the preferred confirmatory method but other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test, particularly when preliminary positive results are used.
The assay is for OTC use.
The materials necessary for confirmation testing are provided with the screening device. Materials, as well as confirmation testing, are provided to the consumer at no additional cost. The consumer pays for shipment of the sample to the laboratory.
3. Special instrument Requirements:
Not applicable. This is a visually-read single-use device.
I. Device Description:
The device is a single-use visually read cassette device. It has a plastic housing that contains the test strip. A plastic sample dispenser is also provided. Several drops of urine are added to start the test which employs traditional immunochromatographic technology.
J. Substantial Equivalence Information:
1. Predicate device name(s):
Acon Multi-Drug Multi-Line Test Device
2. Predicate K number(s):
K020313
3. Comparison with predicate:
Both devices are identical in product design, performance characteristics, materials, manufacturing, matrix used, and are intended for use as an initial screening method subject to confirmation. The proposed device is intended to be sold over the counter (OTC) while the predicate is for prescription use only.
{2}
Page 3 of 4
## K. Standard/Guidance Document Referenced (if applicable):
The sponsor did not reference any standards or guidance documents in the pre-market notification.
## L. Test Principle:
The device employs lateral flow immunochromatographic technology and is based on the principle of competitive binding. Drugs, if present in concentrations below the cutoff level, will not saturate the binding sites of antibody-coated particles in the device. The antibody-coated particles will then be captured by immobilized drug-specific conjugate and a colored line will appear in the test line region. The colored line will not form if the sample contains drug in excess of the cutoff level because the drug will saturate all the binding sites of the drug-specific antibody. Each strip in the device contains a procedural control that appears in the control line region indicating that the proper volume of urine has been added and membrane wicking has occurred.
## M. Performance Characteristics (if/when applicable):
### 1. Analytical performance:
#### a. Precision/Reproducibility:
The accuracy and precision of the test was demonstrated in a consumer study. 503 unique tests were performed by consumers using drug-free urine that had been spiked with various concentrations and combinations of drugs. Each drug was tested at 0%, 50%, 75%, 125%, 150%, and 200% of the target concentration. Some samples contained as many as three drugs; there were combinations that contained no drugs at all. At least 21 but not more than 34 tests were performed for each combination. Drug concentrations were confirmed by GC/MS; recovery ranged between 81 to 116% of the target concentration. Approximately 10% of the consumers had used a home drug kit before. 98% reported that they were high-school graduates and the ratio of female to male was approximately 1:1. Four geographic locations were cited but the settings were not specified.
The results of the study are summarized in the table below:
| Drug | Cutoff Concentration (ng/ml) | Number of Studies | Correctly Interpreted | Incorrectly Interpreted* |
| --- | --- | --- | --- | --- |
| THC | 50 | 169 | 167 | 2 |
| COC | 300 | 165 | 163 | 2 |
| AMP | 1000 | 165 | 161 | 4 |
| mAMP | 1000 | 163 | 161 | 2 |
| OPI | 2000 | 161 | 161 | 2 |
| PCP | 25 | 167 | 165 | 2 |
* All samples that were interpreted incorrectly were ±25% of the cutoff value (75% or 125% of target).
{3}
Page 4 of 4
A consumer questionnaire was administered to evaluate labeling effectiveness. It asked only one question: "Was the test easy to interpret?" Thus it did not determine whether the labeling adequately alerted users to the limitations of home use testing devices. Only one participant of 503 responded that the test was not easy to interpret.
b. Linearity/assay reportable range:
Not applicable for a qualitative assay.
c. Traceability (controls, calibrators, or method):
The device has an internal process control. Users are informed that the control indicates that sufficient urine was added to the test. This is typical of OTC tests. Users are also informed not to interpret the test if the control line does not form.
d. Detection limit:
Issues were addressed in the predicate submission.
e. Analytical specificity:
Issues were addressed in the predicate submission.
f. Assay cut-off:
The identified cutoff concentrations are those recommended by the Substance Abuse and Mental Health Services Administration (SAMHSA). Analytical performance of the device around the cutoff is described in the precision section above.
2. Comparison studies:
a. Method comparison with predicate device:
Not applicable.
b. Matrix comparison:
Not applicable as the device is only intended for use with urine.
3. Clinical studies:
a. Clinical sensitivity:
Not applicable; clinical studies are not typically submitted for this device type.
b. Clinical specificity:
Not applicable; clinical studies are not typically submitted for this device type.
c. Other clinical supportive data (when a and b are not applicable):
Not applicable; clinical studies are not typically submitted for this device type.
4. Clinical cut-off:
Not applicable.
5. Expected values/Reference range:
Not applicable.
N. Conclusion:
The submitted information in this pre-market 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.
