K050050 · ACON Laboratories, Inc. · LDJ · Mar 11, 2005 · Clinical Toxicology
Device Facts
Record ID
K050050
Device Name
ON CALL MULTI-DRUG HOME TEST
Applicant
ACON Laboratories, Inc.
Product Code
LDJ · Clinical Toxicology
Decision Date
Mar 11, 2005
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 862.3870
Device Class
Class 2
Indications for Use
The On Call™ Multi-Drug Home Test for Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates, and Phencyclidine is a screening test for the rapid detection of Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates, and Phencyclidine in urine at a designated cut-off concentration of 50 ng/mL for Marijuana, 300 ng/mL for Cocaine, 1,000 ng/mL for Amphetamine, 1,000 ng/mL for Methamphetamine, 2,000 ng/mL for Opiates, and 25 ng/mL for Phencyclidine. The test is intended for over-the-counter (OTC) consumer use. This assay 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) 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 indicated.
Device Story
Single-use lateral flow immunochromatographic cassette; detects drugs of abuse in urine. User adds urine via dropper; competitive binding principle; drug presence below cutoff allows antibody-coated particles to bind immobilized conjugate, forming colored line. Absence of line indicates drug presence above cutoff. Control line confirms sample volume. Visually read by consumer at home. Preliminary positive results require laboratory confirmation via GC/MS; materials for confirmation provided with device. Benefits include rapid, accessible preliminary screening for drug presence.
Clinical Evidence
Consumer study (n=503) evaluated accuracy and interpretation. Participants tested spiked urine samples at 0%, 50%, 75%, 125%, 150%, and 200% of target concentrations. Results showed high correct interpretation rates; incorrect interpretations were limited to samples within ±25% of cutoff. 99.8% of participants reported the test was easy to interpret.
Technological Characteristics
Lateral flow immunochromatographic cassette; competitive binding principle. Plastic housing with test strip and sample dropper. Visual readout. No electronic components or instrumentation required. Qualitative assay.
Indications for Use
Indicated for OTC screening of urine for Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates, and Phencyclidine in consumers. Provides preliminary results; requires GC/MS confirmation.
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
ACON One Step Multi-Drug Multi-Line Screen Test (K020313)
Submission Summary (Full Text)
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1
# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY DEVICE ONLY TEMPLATE
A. 510(k) Number:
k050050
B. Purpose of the Submission:
New device
C. Analyte:
Amphetamine, Cannabinoids, Cocaine, Methamphetamine, Opiates (Morphine) and Phencyclidine.
A. Type of Test:
Qualitative Lateral Flow Immunochromatographic Test
B. Applicant:
ACON Laboratories, Inc.
C. Proprietary and Established Names:
ACON On Call Multi-Drug Home Test
D. Regulatory Information:
1. Regulation section:
21 CFR 862.3100, Enzyme Immunoassay, Amphetamine
21 CFR 862.3870, Enzyme Immunoassay, Cannabinoids
21 CFR 862.3250, Enzyme Immunoassay, Cocaine and Cocaine Metabolites
21 CFR 862.3610, Thin Layer Chromatography, Methamphetamine
21 CFR 862.3650, Enzyme Immunoassay, Opiates Unclassified, Enzyme Immunoassay, Phencyclidine
2. Classification:
Class II
3. Product Code:
DKZ, LDJ, DIO, LAF, DJG and LCM, respectively.
4. Panel:
Toxicology (91)
E. Intended Use:
1. Intended use(s):
Refer to Indications for use below
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2. **Indication(s) for use:**
The On Call™ Multi-Drug Home Test for Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates, and Phencyclidine is a screening test for the rapid detection of Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates, and Phencyclidine in urine at a designated cut-off concentration of 50 ng/mL for Marijuana, 300 ng/mL for Cocaine, 1,000 ng/mL for Amphetamine, 1,000 ng/mL for Methamphetamine, 2,000 ng/mL for Opiates, and 25 ng/mL for Phencyclidine. The test is intended for over-the-counter (OTC) consumer use.
This assay 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) 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 indicated.
3. **Special condition for use statement(s):**
The On Call™ Multi-Drug Home Test 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 is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.
This assay is for OTC use.
The materials necessary for confirmational testing are provided with the screening device. Materials, as well as confirmational testing, are provided to the consumer at no additional cost. The consumer pays for shipment of the sample to the laboratory.
4. **Special instrument Requirements:**
Not applicable. The device is a visually read single-use device.
F. **Device Description:**
The product is a single-use visually read cassette device. It has a plastic housing that contains the test strip. A plastic sample dropper is also provided with the device. Several drops of urine are added to start the test which employs traditional immunochromatographic technology.
G. **Substantial Equivalence Information:**
1. **Predicate device name(s):**
ACON Multi-Drug Multi-line Test Device, First Check Home Drug Test, Pharmatech at Home Drug Test and Accu-Stat™ Home Drug Test.
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2. Predicate K number(s):
k020313, k993852, k003858 and k040629
3. Comparison with predicate:
This device and the predicate cleared under k020313 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 device cleared under k020313 is prescription use only. Predicates cleared under k993852, k003858 and k040629 are all OTC products.
H. Standard/Guidance Document Referenced (if applicable):
The sponsor did not reference any standards or guidance documents in their premarket submission.
I. 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 the antibody coated particles on the drug specific test strips. The antibody-coated particles will then be captured by immobilized drug-specific conjugate and a colored line will appear in the control region and the test region. If the sample contains drugs above the cutoff level, a colored line will not appear in the strips test region. Formation of a colored line in the control region indicates that the proper volume of urine has been added. If a colored line does not appear in the control region, the test result is inconclusive and should be repeated. The absence or presence of the line is determined visually by the operator.
J. 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.
3
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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).
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:
Performance Characteristics have been addressed in k020313 (ACON Multi-Drug Multi-line Test Device).
e. Analytical specificity:
Performance Characteristics have been addressed in k020313 (ACON Multi-Drug Multi-line Test Device).
f. Assay cut-off:
The identified cutoff concentrations are those recommended by the Substance Abuse and Mental Health Services Administration
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(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.
K. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
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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.
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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.
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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.
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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.
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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.
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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.
