This device is a one-step immunoassay intended to provide qualitative rapid detection of tricyclic antidepressants (TCA) at a cutoff level of 1000 ng/ml in human urine. It is for health care professional use only.

It is for health care professional, in-vitro diagnostic use only.

This device is a one-step immunoassay intended to provide qualitative rapid detection of tricyclic antidepressants (TCA) at a cutoff concentration of 1,000 ng/ml in human urine. It is for health care professional use only.

Instant-View™ TCA Urine Test 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 used.

Device Description

A one-step lateral flow chromatographic immunoassay. The test strip in the device includes 1) a conjugate pad containing colloidal gold coupled with mouse anti-TCA antibodies; 2) nitrocellulose membrane containing a test line (T line) and a control line (C line). The Test line is coated with TCA- BSA, and the Control line is coated with goat anti-mouse IgG antibody.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Instant-View™ TCA Urine Test, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (Implicit)	Reported Device Performance
Accuracy - Negative	High agreement with GC/MS for negative samples	96.7% (58/60) agreement
Accuracy - Positive	High agreement with GC/MS for positive samples	100% (20/20) agreement
Accuracy - Overall	High overall agreement with GC/MS	97.5% overall accuracy
Reproducibility	High agreement across different testing sites and operators	99% agreement across four sites
Specificity - Related Compounds	Positive response to TCA-related compounds at or above cutoff	Positive responses to Amitriptyline, Desipramine, Imipramine, Nortriptyline, Nordoxepine at 1000 ng/ml; Cyclobenzaprine, Protriptyline, Trimipramine > 1500 ng/ml; Doxepine, Clomipramine > 3000 ng/ml.
Specificity - Unrelated Compounds	No significant interference from structurally unrelated compounds	No significant interference observed with structurally unrelated compounds at 1 mg/ml.

Note: The acceptance criteria are implicit based on the reported performance. The document doesn't explicitly state quantitative thresholds the device needed to meet, but rather presents the results as demonstrating "accuracy," "reproducibility," and "specificity."

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

Sample Size for Accuracy Test Set: 80 clinical urine samples.
Data Provenance: The document states "clinical urine samples," which implies human-derived samples. There is no information provided regarding the country of origin of the data or whether it was retrospective or prospective.

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

The ground truth for the accuracy study was established by GC/MS (Gas Chromatography/Mass Spectrometry), which is a chemical method, not human expert interpretation. Therefore, the concept of "number of experts" and "qualifications of experts" as typically applied to imaging or diagnostic interpretation by trained professionals does not directly apply here. GC/MS itself is considered a gold standard for drug quantification.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established by GC/MS, a definitive chemical analysis method, not by human adjudication of potentially subjective interpretations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This study is for an in vitro diagnostic device (immunoassay) for drug detection, not an AI-assisted diagnostic tool that would involve human readers interpreting cases. Therefore, an MRMC comparative effectiveness study is not relevant here.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, the accuracy and reproducibility studies described are standalone performance evaluations of the device itself (the immunoassay) without human interpretation being part of the primary outcome measure. While humans operate the test and interpret its visual output (lines on a strip), the core performance metrics are determined by how accurately the device differentiates between samples at the cutoff compared to the GC/MS reference.

7. Type of Ground Truth Used

The ground truth used was GC/MS (Gas Chromatography/Mass Spectrometry), which is a highly specific and quantitative analytical method, often considered a definitive or "gold standard" for confirming the presence and concentration of drugs.

8. Sample Size for the Training Set

No information is provided regarding a "training set." This device is a lateral flow immunoassay, not a machine learning or AI algorithm that typically requires a distinct training set. The performance is based on its inherent biochemical reactivity and design.

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

Not applicable, as there is no mention or indication of a training set for this type of device.

Summary

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K02-693

510(K) Summary

DEC 0 9 2002 510(k) Summary of

Safety and Effectiveness as Required by 21 CFR 807.92

	Name:	Alfa Scientific Designs, Inc.
Submitter	Address:Contact Person:E-mail:	12330 Stowe DrivePoway, CA 92064Telephone: (858) 513-3888Fax: (858) 513-8388Naishu Wang, MD, Ph.D.wnss@alfascientific.com
Device Name	Trade Name: Instant-View™ TCA Urine TestCommon Name: Immunoassay, TCA Urine TestClassification: Tricyclic antidepressant drugs test system(21 CFR 862.3910) Class II
Date of SummaryPreparation	November, 5, 2002
Predicate Device	SureStep™ Drug Screen TCA Test, Applied Biotech, Inc.,K981605
Device Description	A one-step lateral flow chromatographic immunoassay. Thetest strip in the device includes 1) a conjugate pad containingcolloidal gold coupled with mouse anti-TCA antibodies; 2)nitrocellulose membrane containing a test line (T line) and acontrol line (C line). The Test line is coated with TCA- BSA,and the Control line is coated with goat anti-mouse IgGantibody.
Summary of theSimilarity to thePredicate Device	• Both are one-step lateral-flow chromatographicimmunoassay.• Both are intended to provide qualitative detection ofTricyclic Antidepressants at 1000 ng/ml, the cutoff level.• Both are based on the similar mechanism of competitivebinding immunoassay.• Both use a C line as built-in control to indicate that anappropriate volume of sample is applied and whether thedevice functions properly• Both provide a preliminary result and need to be confirmedwith a more solid reference method, e.g. GC/MS or HPLC.
Intended Use	This device is a one-step immunoassay intended to providequalitative rapid detection of tricyclic antidepressants (TCA)at a cutoff level of 1000 ng/ml in human urine. It is for healthcare professional use only.
Accuracy studies	The accuracy of the device was evaluated with 80 clinicalurine samples calibrated with GC/MS. The negative resultsagreed 96.7% (58/60). The positive results agreed 100%(20/20). The overall accuracy was 97.5%.
Reproducibilitystudies	The reproducibility of this device was studied at threePhysician's Office Laboratories (POL) and one referencelaboratory. Evaluations were performed by personnel withdiverse educational backgrounds and working experiences.The results from the four evaluation sites agreed 99%,indicating a high reproducibility of the device.
Specificity studies	Instant-View™ TCA Urine Test has positive responses tostructurally related compounds, Amitriptyline, Desipramine,Imipramine, Nortriptyline, and Nordoxepine, at aconcentration of 1000 ng/ml; to Cyclobenzaprine,Protriptyline, and Trimipramine at a concentration higher than1500 ng/ml; to Doxepine and Clomipramine at aconcentration higher than 3000 ng/ml. No significantinterference observed with this device by the structurallyunrelated compounds tested at a concentration of 1 mg/ml.
Conclusion	The results of accuracy, reproducibility, and specificitystudies demonstrate that the Instant-View™ TM TCA Urine Test issubstantially equivalent to the legally marketed test.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services, USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" around the perimeter. In the center of the seal is an abstract symbol that resembles three curved lines or waves.

DEC 0 9 2002

098 Gaither Road Rockville MD 20850

Naishu Wang, M.D., Ph.D. President Alfa Scientific Designs, Inc. 12330 Stowe Drive Poway, California 92064

Re: K022693

Trade/Device Name: Instant-View™ TCA Urine Test Regulation Number: 21 CFR § 862.3910 Regulation Name: Tricyclic antidepressant drugs test system Regulatory Class: II Product Code: MLK Dated: November 6, 2002 Received: November 12, 2002

Dear Dr. Wang :

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.

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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). 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). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(K) NUMBER (IF KNOWN) :

DEVICE NAME : Instant-View™ TCA Urine Test

INDICATIONS FOR USE:

It is for health care professional, in-vitro diagnostic use only.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use (Optional Format 1-2-96)

Sean Cooper

(Division Sign-Off) Division of Clinical Laboratory D 51'0(k) Number

Regulation Number and Section

§ 862.3910 Tricyclic antidepressant drugs test system.

(a)
Identification. A tricyclic antidepressant drugs test system is a device intended to measure any of the tricyclic antidepressant drugs in serum. The tricyclic antidepressant drugs include imipramine, desipramine, amitriptyline, nortriptyline, protriptyline, and doxepin. Measurements obtained by this device are used in the diagnosis and treatment of chronic depression to ensure appropriate therapy.(b)
Classification. Class II (special controls). A tricyclic antidepressant drugs 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).