The Psychemedics Microplate EIA for Cocaine is an enzyme immunoassay (EIA) for the preliminary qualitative detection of cocaine in human head and body hair samples using a cocaine calibrator at 5 ng /10 mg hair cutoff for the purpose of identifying cocaine use. This product is intended exclusively for in-house professional use only and not for sale to anyone.

The Psychemedics EIA Cocaine Assay provides only a preliminary analytical test result. To obtain a quantitative analytical result or to confirm positive results, a more specific alternate chemical method (e.g. GC/MS) must be used. Clinical consideration and professional judgment should be applied to the interpretation of any drug-of-abuse test result.

Device Description

The test consists of two parts; a pre-analytical hair treatment procedure (to convert the solid matrix of hair to a measurable liquid matrix) and the screening assay, the Psychemedics Microplate EIA for Cocaine. The drug is recovered from the hair using a patented method (U.S. Patent #8,084,215). The screening portion of the test system consists of (1) microplate wells coated with multiple drugs including benzoylecgonine conjugated to bovine serum albumin (BSA) (patent pending), monoclonal mouse anti-cocaine, goat anti-mouse secondary antibody conjugated to HRP (horseradish peroxidase), substrate [3, 3', 5, 5' tetramethylbenzidine (TMB)], HCl to acidify the final reaction, and wash buffer for washing the plates. Absorbance in the wells is read with a microplate reader.

AI/ML Overview

Acceptance Criteria and Study for Psychemedics Microplate EIA for Cocaine in Hair

The Psychemedics Microplate EIA for Cocaine in Hair is an enzyme immunoassay (EIA) for the preliminary qualitative detection of cocaine and its metabolites in human head and body hair. The device's performance was evaluated against a predicate device (Psychemedics Cocaine Assay, K010868) and confirmed by LC/MS/MS (liquid chromatography/mass spectrometry/mass spectrometry).

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state pre-defined acceptance criteria for the accuracy of the new device relative to the predicate or LC/MS/MS. However, the study aims to demonstrate "substantial equivalence" to the predicate and "substantially equivalent" results to LC/MS/MS. Based on the presented data, the implicit acceptance criteria appear to be:

High agreement with the predicate device.
High agreement with LC/MS/MS for confirmed samples.
No significant impact of cosmetic treatments on negative or positive samples.
Effective wash procedure to mitigate external contamination.
Stability of calibrator and control solutions.
Cross-reactivity within acceptable limits for related compounds, and minimal to no cross-reactivity or interference from other common compounds.
Equivalent recovery to the predicate device.

Here's a summary of the reported device performance against these implicit criteria:

Acceptance Criteria (Implicit)	Reported Device Performance
Agreement with Predicate Device	Four hundred-twenty-five hair samples were compared. <1% discordance between the EIA and predicate RIA. Importantly, the 4 discordant samples (positive by predicate, negative by EIA) were also found negative by LC/MS/MS, suggesting the EIA's results were correct.
Agreement with LC/MS/MS (Confirmation Study)	Strong agreement for the 256 samples confirmed by LC/MS/MS.
(From provided table)	EIA Positive (when LC/MS/MS is) * ≥ Cutoff, And < +50% of Cutoff: 12/12 samples (100%) * ≥ +50% of Cutoff and < +100% of Cutoff: 5/5 samples (100%) * ≥ +100% of cutoff: 101/101 samples (100%)EIA Negative (when LC/MS/MS is) * Zero: 118/118 samples (100%) * ≥ 10% and <50% of Cutoff: 9/9 samples (100%) * ≥ -50% of Cutoff and < Cutoff: 3/3 samples (100%)The table shows that the EIA correctly identified all samples well above the cutoff as positive and all samples well below the cutoff as negative. There were no false positives when LC/MS/MS was zero or significantly below the cutoff, and no false negatives when LC/MS/MS was significantly above the cutoff. There were 8 samples that were EIA Positive where LC/MS/MS showed "≥ -50% of Cutoff and > Cutoff", and 12 samples for "≥ Cutoff, And < +50% of Cutoff", indicating good performance at or around the cutoff.
Impact of Cosmetic Treatments	- Negative Samples: No significant differences observed; all 20 negative samples for each treatment type (bleach, perm, dye, relaxer, shampoo) remained negative after treatment (total 100 samples).- Positive Samples: No positive samples became negative after any of the cosmetic treatments (bleach, perm, dye, relaxer, shampoo). Mean B/B₀ x 100 values for positive samples showed slight variations but remained positive after treatment.
Effectiveness of Wash Procedure	- High Contamination (1000 ng cocaine/mL water): Amounts on hair reduced from 38.6-98.7 ng/10 mg to 1.1-3.0 ng/10 mg after washing. None at or above cutoff before wash criterion applied.- Moderate Contamination (1000 ng cocaine/mL saline): Amounts on hair reduced from 8.5-29.3 ng/10 mg to 0.2-1.0 ng/10 mg after washing. All samples were negative (below cutoff) even without wash criterion.
Stability of Calibrator and Control Solutions	Stability of cocaine in methanol in the presence of other drugs of abuse was shown to exceed 1 year.
Cross-reactivity and Interference	- Cross-reactivity: Seven related compounds showed cross-reactivity ranging from 2.5% (Norbenzoylecgonine) to 76.9% (Cocaethylene).- No Cross-reactivity: Seventy-nine other compounds showed no cross-reactivity.- No Interference: One hundred-forty-one compounds tested at +/-50% of the cutoff showed no interference.
Recovery Study	Recovery of cocaine and benzoylecgonine from hair of cocaine users was shown to be substantially equivalent to that of the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size:
- Agreement Testing: 425 hair samples were used for comparison between the predicate device and the new EIA.
- LC/MS/MS Confirmation: 256 of the 425 samples were further confirmed by LC/MS/MS.
- Cosmetic Treatment Study: 20 negative hair samples per treatment type (5 types = 100 samples), and 12 positive hair samples per treatment type (5 types = 60 samples).
- Contamination Study: 8 hair samples per contamination method (water and saline = 16 samples).
Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given the nature of a 510(k) submission for a diagnostic device, the studies are typically conducted in a controlled laboratory environment using collected human samples, implying real-world (prospective or retrospectively collected and stored) human hair samples. The samples included both head and body hair (15.8% were body hair samples).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The ground truth for the agreement and confirmation studies was established by LC/MS/MS, which is a highly specific and quantitative analytical chemical method, considered the "gold standard" for drug confirmation in forensic toxicology.
No human "experts" in the sense of clinicians or radiologists are mentioned as establishing the ground truth for the test set results. The ground truth refers to the analytical confirmation by LC/MS/MS, performed by trained laboratory personnel.

4. Adjudication Method for the Test Set

For the agreement testing, discrepancies between the new EIA device and the predicate RIA device (<1% of samples) were adjudicated by LC/MS/MS. The document states, "The samples were negative by LC/MS/MS, demonstrating that the EIA negative results, although discordant with the predicate, are correct." This indicates that LC/MS/MS served as the ultimate adjudicator for discordant results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This product is an in-vitro diagnostic (IVD) assay, not an imaging device for human interpretation. Therefore, a multi-reader, multi-case comparative effectiveness study involving human readers is not applicable. The device's performance is determined by its analytical accuracy against a gold standard (LC/MS/MS), not by human interpretation improvement.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes. The primary studies presented (Agreement Testing, LC/MS/MS Confirmation, Cosmetic Treatment, Contamination, Cross-reactivity, and Recovery) all demonstrate the standalone performance of the Psychemedics Microplate EIA for Cocaine in Hair. The output is a preliminary qualitative result (positive/negative based on cutoff), without direct "human-in-the-loop" interpretation for the initial screening result itself. The "human-in-the-loop" aspect comes in the professional judgment for clinical interpretation of any drug-of-abuse test result and the requirement for confirmation by a more specific method for positive preliminary results.

7. The Type of Ground Truth Used

The primary ground truth used for validating the device's accuracy is LC/MS/MS (Liquid Chromatography/Mass Spectrometry/Mass Spectrometry). This is a highly sensitive and specific analytical method for identifying and quantitating substances.
For the agreement study, the predicate device (Psychemedics Cocaine Assay, K010868) also served as an initial comparison point, though LC/MS/MS was used to resolve discrepancies.

8. The Sample Size for the Training Set

The document does not explicitly state the sample size for a training set. For an IVD assay like this, development typically involves internal validation and optimization, but the 510(k) summary focuses on the performance studies used for regulatory submission. It is common for the public summary to detail testing data rather than development/training data for such devices.

9. How the Ground Truth for the Training Set Was Established

As the document does not explicitly mention a "training set" in the context of machine learning or AI models, it also does not describe how the ground truth for a training set was established. For an immunoassay, the "training" involves optimizing reagents, protocols, and cutoff values, likely guided by samples with known cocaine concentrations confirmed by methods like GC/MS or LC/MS/MS during the assay development phase.

Summary

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510K SUMMARY

510K Number: Submitted By: K111925 Psychemedics Corporation 5832 Uplander Way Culver City, CA 90230 TEL: 310 216 7776 FAX: 310 216 6662

Submission Contact:

Date Prepared:

Device Trade Name:

Predicate Device:

Product Code:

Device Classification/Name:

Intended Use:

Assay Description:

Sample Collection: ·

Psychemedics Corporation
5832 Uplander Way
Culver City, CA 90230
TEL: 310 216 7776
FAX: 310 216 6662

Virginia Hill

April 25, 2012

Psychemedics Microplate EIA for Cocaine in Hair

Psychemedics Cocaine Assay, K010868

.الا الام

21 CFR 862.3250, Enzyme Immunoassay, Cocaine; Classification II;

A sample of hair should be cut as close as possible to the skin. The hair is placed in a V-shaped aluminum foil sample holder with the root end of the hair protruding beyond the slanted edge of the foil. The aluminum foil is crimped around the sample, securing the hair specimen firmly into

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place within the foil. The hair sample crimped within the foil is placed in a sample acquisition card envelope and the envelope is sealed with a tamper-evident seal. Hair specimens are kept at ambient temperature in a secure location until they are shipped without refrigeration to the laboratory.

Materials required:

Hair sample collection kit, Microplate EIA for Cocaine, Microplate washer and reader, LC/MS/MS for confirmation.

Comparison of Psychemedics Microplate EIA for Cocaine with Psychemedics RIA Assay for Cocaine

Item	Device	Predicate
Indications for Use	The Psychemedics Microplate EIA forCocaine is an enzyme immunoassay(EIA) for the preliminary qualitativedetection of cocaine in human headand body hair samples using a cocainecalibrator at 5 ng /10 mg hair cutoff forthe purpose of identifying cocaine use.This product is intended exclusivelyfor in-house professional use only andnot for sale to anyone. The test is notintended for over-the-counter sale tonon-professionals.The Psychemedics EIA Cocaine Assayprovides only a preliminary analyticaltest result. To obtain a quantitativeanalytical result or to confirm positiveresults, a more specific alternatechemical method (e.g. LC/MS/MS)must be used. Clinical considerationand professional judgment should beapplied to the interpretation of anydrug-of-abuse test result.	The Psychemedics Cocaine assay is aradioimmunoassay (RIA) for thequalitative and semi-quantitativedetection of cocaine in head hiar, leghair, underarm hair and chest hairthrough the measurement of cocaineand cocaine metabolites atconcentrations at or above a 5 ng/10mg hair cutoff. For a quantitativeanalytical results or to confirmpositive results via the presence ofcocaine and cocaine metabolites, amore specific alternate chemicalmethod must be used in order toobtain a confirmed analytical result.
510k	K111925	K010868
Measurand	Cocaine	Cocaine
Matrix	Human head or body hair	Human head or body hair
Cutoff concentration	5 ng cocaine/10 mg hair	5 ng cocaine /10 mg hair
Type of Test	Enzyme Immunoassay	Radioimmunoassay
Method ofmeasurement	Microplate reader	Gamma counter
Extraction Method	NonproteolyticDigestion	Proteolytic Digestion
ConfirmationMethod	LC/MS/MS	LC/MS/MS

Summary of Performance Testing:

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Summary -Intra-Assay			Summary-Inter-Assay
LEVEL	NEG	POS	LEVEL	NEG	POS
B₀ (-100%)	15	0	B₀ (-100%)	75	0
-75%	15	0	-75%	75	0
-50%	15	0	-50%	75	0
-25%	15	0	-25%	75	0
plus 25%	0	15	plus 25%	0	75
plus 50%	0	15	plus 50%	0	75
plus 75%	0	15	plus 75%	0	75
plus 100%	0	15	plus 100%	0	75

Agreement Testing

Four hundred-twenty-five hair samples were assayed by the predicate device and by the Psychemedics Cocaine EIA. Four samples near the cutoff and positive with the predicate device were negative with the EIA device and by LC/MS/MS. The discordance between EIA and RIA was < 1%. Of the total samples, 15.8% were body hair samples.

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Two-hundred fifty-six of the samples were confirmed by LC/MS/MS, with the results shown in the following table.

LC/MS/MS:	Zero	≥ 10%and <50%of Cutoff	≥ -50% ofCutoffand >Cutoff	≥ Cutoff,And <+50% ofCutoff	≥ +50% ofCutoff and< +100% ofCutoff	≥ +100%of cutoff
EIA Positive	0	0	8	12	5	101
EIA Negative	118	9	3	0	0	0

Samples vary in the amount of contamination on the surface; in fact, contamination is, by its very nature, random in the way in which it may present on the hair sample. Therefore, it is not surprising that a sample might be positive in one screening assay and not in the next, even if the assays are the same technology. The samples were negative by LC/MS/MS, demonstrating that the EIA negative results, although discordant with the predicate, are correct.

Cosmetic Treatment Study

Twenty cocaine-negative hair samples were treated with bleach, 20 with permanent wave, 20 with dye, 20 with relaxer, and 20 with shampoo, and the results compared to the same samples without the treatments. In each case of the 20 samples treated with a type of cosmetic treatment, 10 samples were treated with one brand of a particular product and 10 other samples with a second brand. No significant differences were

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observed for the negative hair samples before and after the treatments; all samples remained negative after the treatments.

Twelve cocaine-positive hair samples were treated with bleach, 12 with permanent wave, 12 with dye, 12 with relaxer, and 12 with shampoo, and the results compared to the same samples without the treatments. In each case of the 12 samples treated with a type of cosmetic treatment, 6 samples were treated with one brand of a particular product and 6 other samples with a second brand. The means and ranges of the EIA results of the 12 samples before and after the cosmetic treatments are shown in the table below. No positive samples became negative after the cosmetic treatments.

TreatmentStatus	Bleach	Dye	Perm	Relaxer	Shampoo
	Mean (Range) of B/B₀ x 100 Values of 12 Cocaine-Positive Hair Samples in Cocaine EIA
Before	11.4 (2.9 – 19.2)	11.6 (2.9 – 22.5)	9.9 (2.9 – 17.6)	12.1 (4.2 – 26.0)	15.6 (2.9 – 54.6)
After	13.4 (3.0 – 18.8)	12.9 (2.8 – 30.9)	14.4 (6.8 – 24.8)	14.9 (4.9 – 29.8)	15.4 (2.7 – 57.4)

Contamination Study

Potential environmental contamination of samples that are identified as presumptive positive in the screening assay is addressed by an extensive washing procedure prior to confirmation and application of a wash criterion following confirmation, as described below.

Contamination of 8 hair samples by soaking in 1000 ng cocaine /mL of water resulted in a range of cocaine on the hair of 38.6 to 98.7 ng of cocaine /10 mg hair before washing. After washing by the procedure described below, the amount of cocaine remaining on the hair samples ranged from 1.1 to 3.0 ng/10 mg hair, with no samples at or above the cutoff even before application of the wash criterion.

Contamination of 8 hair samples by soaking in 1000 ng cocaine /mL of saline resulted in a range of cocaine on the hair of 8.5 to 29.3 ng of cocaine /10 mg hair before washing. After washing by the procedure described below, the amount of cocaine remaining on the hair samples ranged from 0.2 to 1.0 ng/10 mg hair, with all samples negative (i.e., below the cutoff) even without application of the wash criterion.

The Wash Procedure

Wash by Psychemedics' standard wash procedure: a.
- Add 2 mL of dry isopropanol and shake in waterbath for 15 minutes at 37°C with i. shaking @ 100 -120 oscillations/minute. Remove isopropanol.
- ii. Add 2 mL of Wash Buffer (0.01 M phosphate buffer, pH 6.0, containing 0.1% BSA) and shake in waterbath for 30 minutes at 37℃ with shaking @ 100 -120 oscillations/minute. Remove Buffer.
- iii. Repeat Step ii. two more times.
- iv. Add 2 mL of Wash Buffer, and shake in waterbath for 60minutes at 37°C with shaking @ 100 -120 oscillations/minute. Remove Buffer.
- Repeat Step iv. one more time. Remove Buffer. Save last wash buffer. v.
Analyze last wash for cocaine. b.

Confirmation and Interpretation

Perform confirmation procedures for cocaine and metabolites. C.
Calculate wash criterion: d.

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i. Multiply the last wash value x 5.
Subtract the value of the drug in the last wash from the value ii. of the parent drug in the digested hair.

iii. If the result is less than the cutoff for the parent drug, the sample is interpreted as contaminated. If the result is > the parent drug cutoff, in combination with other metabolite criteria, the sample is interpreted as positive due to ingestion. The parent-drug cutoff value for cocaine is 5 ng/ 10 mg hair.

Cross-reactivity and Interference Studies

Seven compounds, shown in the table below, showed cross-reactivity in the Cocaine assay. Seventynine other compounds showed no cross-reactivity in the assay. One-hundred-forty-one compounds tested for interference at +/-50% of the cutoff showed no interference in the assay.

Cross-reactivity of related Compounds in Cocaine EIA
Compound	Amount of Compoundrequired to Produce a positivetest at the cutoff of 5 ngcocaine/10 mg hair	Percent Cross-reactivity*
Benzoylecgonine	80	6.3
Norbenzoylecgonine	200	2.5
Norcocaine	8.0	62.5
Norcocaethylene	11	45.5
Cocaethylene	6.5	76.9
Benzoylecgonine Isopropyl ester	9	55
Tropacocaine	13	38.5

. .

Stability of Calibrator and Control Solutions

The cocaine calibrator and control solutions are prepared in-house by the laboratory from certified standards. Stability of cocaine in methanol in the presence of other drugs of abuse was shown to exceed 1 year.

Recovery Study

Recovery of cocaine and benzoylecgonine from hair of cocaine users was shown to be substantially equivalent to that of the predicate device.

Conclusion:

The Psychemedics Microplate EIA for Cocaine in Hair is substantially equivalent to the predicate device K010868, and the results are substantially equivalent to LC/MS/MS results.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with its wings spread, positioned to the right. Encircling the bird is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The text is in all caps and appears to be in a sans-serif font.

Food and Drug Administration

10903 New Hampshire Avenue Silver Spring, MD 20993

Psychemedics Corporation c/o Virginia Hill Senior Scientist 5832 Uplander Way Culver City, CA 90230

MAY - 1 2012

K111925 Re: Psychemedics Microplate EIA for Cocaine in Hair Trade/Device Name: Regulation Number: 21CFR 862.3250 Regulation Name: Enzyme Immunoassay, Cocaine and Cocaine metabolites Regulatory Class: Class II Product Code: JXO Dated: March 9, 2012 Received: March 12, 2012

Dear Ms. Hill:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 310(x) prematically equivalent (for the indications for referenced above and nave delemined the devices marketed in interstate commerce
use stated in the enclosure) to legally mark the M. Lies Amedenents, or to devices that use stated in the enclosure) to legally hiar cleare device Amendments, or to devices that prior to May 28, 1976, the enactified in the Massar Son Federal Food, Drug, and Cosmetic
have been reclassified in accordance with the provisions of the Federal September 19 have been reclassified in acconualice with the provisions of the Act. The Act. The general Act (Act) that do not require approval ot a picmaller applo rar applo raires of the Act. The general
therefore, market the device, subject to the general somises provisions therefore, market the device, subject to the general one personal issing of devices, good
controls provisions of the Act include requirements for annoingsismation and anylera controls provisions of the Actimende requirements for annual 149
manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) into Enier easy in (cass in the materice and be
may be subject to such additional controls. may be subject to such additional controls. Exismig major regalatas. found in Title 21, Code of Pederal Rogalances (120))
publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA issuance of a substantial order requirements of the Act or
that FDA has made a determination that your device complies with and somply that FDA has made a determination intered by other Federal agencies. You must comply
any Federal statutes and regulations administered by consistes. You must comply any Federal statutes and regulations administered by other trepistration and listing (21 CFR Part
with all the Act's requirements, including, but not limited to: registration with all the Act's requirements, including, but not more we regulation of the more of the more of the more of the many as set
807); labeling (21 CFR Parts 801 and 809); and 807); fabeling (21 CFR RT arts 600 = 1.0 cm (21 CFR Part 820).

This letter will allow you to begin marketing your device as described in your Section 510(k)
1978 (contraction of the TP to City of substantial aquivalence of your device t This letter will allow you to begal marketing your device of your device to a legally
premarket notification. The FDA finding of substantial equir device and this, permits y premarket notification. The FDA finding of substantial equivations of your device to proceed to the market.

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Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical

Devices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance ...

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm

Sincerely yours,

signature

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indication for Use

510(k) Number (if known): K111925

Device Name: Psychemedics Microplate EIA for Cocaine in Hair

Indication For Use:

The Psychemedics Microplate EIA for Cocaine is an enzyme immunoassay (EIA) for the preliminary qualitative detection of cocaine and metabolites in human head and body hair using a cocaine calibrator at 5 ng /10 mg hair cutoff for the purpose of identifying cocaine use. This product is intended exclusively for in-house professional use only and is not for sale to anyone.

The Psychemedics Microplate EIA for Cocaine in Hair provides only a preliminary analytical test result. To confirm a presumptive screen positive result, a more specific alternate chemical method such as LC/MS/MS (liquid chromatography/mass spectrometry/mass spectrometry) must be used. Clinical consideration and professional judgment should be applied to the interpretation of any drug-of-abuse test result.

Prescription Use _ (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use _ X (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K111925

Regulation Number and Section

§ 862.3250 Cocaine and cocaine metabolite test system.

(a)
Identification. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.(b)
Classification. Class II (special controls). A cocaine and cocaine metabolite 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).