The First Sign Drug of Abuse Tests are rapid, chromatographic immunoassays for the qualitative detection of drugs-of-abuse in human urine. The tests may be run singly of in combinations of up to six drugs simultaneously. The cut-off concentrations and specific analytes tested for are listed below.

This assay provides only a preliminary test result. A more specific alternate chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical and professional judgment must be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.

For Professional Use Only.

Device Description

The First Sign Drug of Abuse Tests are rapid, chromatographic immunoassays for the qualitative detection of drugs-of-abuse in human urine.

AI/ML Overview

Here's an analysis of the provided text, outlining the acceptance criteria and study details for the First Sign™ Drug of Abuse Urine Screening Tests:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this type of device (qualitative drug screening) are typically based on strong agreement with a definitive, confirmatory method. While explicit percentage targets (e.g., "must achieve >95% positive agreement") aren't directly stated as "acceptance criteria" in the submission, the performance characteristics provided demonstrate successful achievement of high agreement rates relative to the gold standard.

First Sign Test	Acceptance Criteria (Implied by Predicate and Type of Test)	Reported Device Performance (Positive Agreement)	Reported Device Performance (Negative Agreement)	Reported Device Performance (Overall Agreement)
Nortriptyline	High agreement (e.g., >95%) with GC/MS or HPLC	97.5%	>99%	98.7%
Secobarbital	High agreement (e.g., >95%) with GC/MS or HPLC	97.4%	97.6%	97.5%
MDMA	High agreement (e.g., >95%) with GC/MS or HPLC	92.5%	>99%	96.2%
Oxazepam	High agreement (e.g., >95%) with GC/MS or HPLC	95.7%	>99%	97.5%
Methadone	High agreement (e.g., >95%) with GC/MS or HPLC	93.7%	97.9%	96.2%
Oxycodone	High agreement (e.g., >95%) with GC/MS or HPLC	95%	>99%	97.5%

Note on Acceptance Criteria: For a 510(k) submission, the "acceptance criteria" are implicitly met when the sponsor demonstrates substantial equivalence to predicate devices, which typically includes performance data that is comparable or superior to the predicate. High positive, negative, and overall agreement rates with a confirmatory method are standard for establishing performance for qualitative drug tests.

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

Sample Size: The document does not explicitly state the total sample size (number of urine samples/patients) used for the test set for each drug. It provides percentages (e.g., 97.5% positive agreement), which are derived from a sample, but the raw numbers of positive and negative samples are not given.
Data Provenance: The document does not specify the country of origin of the data. It mentions that WHPM, Inc. is in El Monte, CA, and WHPM, Bioresearch and Technology Co. Ltd. is in Beijing, China, and that product would be manufactured in both locations. However, where the clinical samples were collected is not stated. The study described is a "clinical evaluation," implying it was prospective or at least involved testing on clinical samples (as opposed to entirely in-silico or simulated data).

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

Number of Experts: Not applicable. The ground truth was established by laboratory methods (GC/MS or HPLC), not human experts interpreting the results of the rapid test.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. The ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS) or High-Performance Liquid Chromatography (HPLC), which are objective analytical methods, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a rapid, chromatographic immunoassay, not an imaging or interpretive AI device where human readers are involved in the primary result generation. The test provides a direct positive/negative result, not an interpretation of complex data by a human.
Effect Size of Human Readers with/without AI: Not applicable, as there's no AI component or human interpretation in the workflow described.

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

Standalone Performance: Yes, the described performance results are for the device (the immunoassay) operating in a standalone capacity. The comparison is between the immunoassay result and the confirmatory laboratory method. There is no human interpretation or intervention in determining the First Sign test result itself (beyond reading the visible lines, which is standard for such tests).

7. The Type of Ground Truth Used

Ground Truth Type: The ground truth was established using confirmatory analytical laboratory methods:
- Gas Chromatography/Mass Spectrometry (GC/MS)
- High-Performance Liquid Chromatography (HPLC)
  These are considered the gold standard for drug detection and quantification in urine.

8. The Sample Size for the Training Set

Training Set Sample Size: The document does not mention a training set. This is typical for traditional immunoassay devices based on chemical reactions rather than machine learning algorithms. Immunoassays are "trained" during their development and optimization phases in the lab, but there isn't a distinct "training set" of patient data in the same way there would be for an AI algorithm.

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

Ground Truth for Training Set: Not applicable, as there is no specific "training set" of patient data in the context of an immunoassay. The inherent "ground truth" for developing such a test is the known presence/absence and concentration of analytes in controlled laboratory samples used during R&D.

Summary

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K052/97

JUN - 9 2006

510(k) Summary

Date of Summary: 30 May, 2005

Product Name

First Sign™ Drug of Abuse Urine Screening Tests

Sponsor and Manufacturer

WHPM, Inc. 9662 Telstar Avenue El Monte, CA 91731

WHPM, Bioresearch and Technology Co. Ltd. 806 Taihong Mansion, No 44 Chongwai Street Chongwai District Beijing, China 100062

Product will be manufactured in both locations and distributed through the California site.

Correspondent

Fran White, President MDC Associates, LLC 163 Cabot Street Beverly, MA 01915

Substantial Equivalency

The First Sign™ Drug of Abuse Urine Screening Test is substantially equivalent to other tests currently on the market.

First Sign Test Analyte	Predicate Device Name	Predicate Device 510(k) #
Oxazepam	ACON BZO One Step Benzodiazepine Test Strip	K012300
Oxycodone	ACON OXY One Step Oxycodone Test Strip	K043507
Secobarbital	ACON BAR One Step Barbiturates Test Strip	K050593
Methadone	ACON MTD One Step Methadone test Strip	K012595
Nortriptyline	ACON TCA One Step Tricyclic Antidepressants	K021526
MDMA	ACON MDMA One Step Ecstasy Test Strip	K022589

Product Description

The First Sign Drug of Abuse Tests are rapid, chromatographic immunoassays for the qualitative detection of drugs-of-abuse in human urine.

Indications for Use

The First Sign Drug of Abuse Tests are rapid, chromatographic immunoassays for the qualitative detection of drugs-of-abuse in human urine. The tests may be run singly or in combinations of up to six drugs simultaneously. The cut-off concentrations for these drugs are as follows: Nortriptyline 1,000ng/mL, Secobarbital 300ng/mL, MDMA 500ng/mL, Oxazepam 300ng/mL, Methadone 300ng/mL, Oxycodone 100ng/mL. For Professional Use Only.

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Performance Characteristics

A clinical evaluation compared test results between the First Sign Drugs of Abuse Tests and GC/MS or HPLC results. The results are summarized below.

First Sign Test	Positive Agreement	Negative Agreement	Overall Agreement
Nortriptyline	97.5%	>99%	98.7%
Secobarbital	97.4%	97.6%	97.5%
MDMA	92.5%	>99%	96.2%
Oxazepam	95.7%	>99%	97.5%
Methadone	93.7%	97.9%	96.2%
Oxycodone	95%	>99%	97.5%

Conclusion

Clinical studies demonstrate the substantial equivalence between the First Sign Drugs of Abuse Tests [Nortriptyline, Secobarbital, MDMA, Oxazepam, Methadone, and Oxycodone] and commercially available FDA-cleared drugs of abuse tests. The studies also demonstrated that the First Sign tests are safe and effective in detecting drugs of abuse at or above their stated cut-off concentrations.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is positioned to the right of a circular emblem that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN - 9 2006

WHPM, Inc c/o Ms. Fran White President MDC Associates, LLC. 163 Cabot Street Beverly, MA 01915

Re: K052197

Trade/Device Name: First Sign Drug of Abuse Urine Screening Test Regulation Number: 21 CFR 862.3620 Regulation Name: Methadone test system Regulatory Class: Class II Product Code: DJR, LFG, DIS, LAF, JXM, DJG Dated: May 11, 2006 Received: May 12, 2006

Dear Ms. White:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good 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 may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 --

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Alberto Gutierrez, Ph.D.

Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K052197

Device Name: First Sign Drug of Abuse Urine Screening Test

Indications For Use:

For Professional Use Only.

Test Name	Analyte Tested	Cut-off Concentration
First Sign Nortriptyline	nortriptyline	1,000ng/mL
First Sign Secobarbital	secobarbital	300ng/mL
First Sign MDMA	mdma	500ng/mL
First Sign Oxazepam	oxazepam	300ng/mL
First Sign Oxycodone	oxycodone	100ng/mL
First Sign Methadone	methadone	300ng/mL

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CORH. Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

Page 1 of 1

Regulation Number and Section

§ 862.3620 Methadone test system.

(a)
Identification. A methadone test system is a device intended to measure methadone, an addictive narcotic pain-relieving drug, in serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of methadone use or overdose and to determine compliance with regulations in methadone maintenance treatment.(b)
Classification. Class II (special controls). A methadone 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).