INSTANT-VIEW TCA URINE TEST

K022693 · Alfa Scientific Designs, Inc. · MLK · Dec 9, 2002 · Clinical Toxicology

Device Facts

• Record ID: K022693
• Device Name: INSTANT-VIEW TCA URINE TEST
• Applicant: Alfa Scientific Designs, Inc.
• Product Code: MLK · Clinical Toxicology
• Decision Date: Dec 9, 2002
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.3910
• Device Class: Class 2

Intended Use

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. 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 Story

Instant-View™ TCA Urine Test is a one-step lateral flow chromatographic immunoassay for qualitative detection of tricyclic antidepressants in human urine. Device utilizes a test strip containing a conjugate pad with colloidal gold-labeled mouse anti-TCA antibodies and a nitrocellulose membrane with a test line (TCA-BSA) and a control line (goat anti-mouse IgG). Sample application triggers competitive binding; presence of TCA in urine inhibits antibody binding to the test line. Healthcare professionals interpret visual lines to determine preliminary results. Device is intended for point-of-care or laboratory use. Results require confirmation via GC/MS or HPLC. Provides rapid screening to assist clinical decision-making regarding potential drug exposure.

Clinical Evidence

Bench testing only. Accuracy evaluated with 80 clinical urine samples calibrated against GC/MS. Negative agreement 96.7% (58/60); positive agreement 100% (20/20); overall accuracy 97.5%. Reproducibility assessed at four sites (three Physician's Office Laboratories and one reference lab) with 99% agreement. Specificity testing confirmed cross-reactivity with structurally related compounds (Amitriptyline, Desipramine, Imipramine, Nortriptyline, Nordoxepine) at 1000 ng/ml, with higher concentrations required for others (Cyclobenzaprine, Protriptyline, Trimipramine, Doxepine, Clomipramine). No interference observed with unrelated compounds at 1 mg/ml.

Technological Characteristics

Lateral flow chromatographic immunoassay. Components: conjugate pad (colloidal gold-mouse anti-TCA antibodies), nitrocellulose membrane (TCA-BSA test line, goat anti-mouse IgG control line). Qualitative visual readout. Standalone device. No energy source required.

Indications for Use

Indicated for healthcare professionals for the qualitative, rapid, in-vitro detection of tricyclic antidepressants (TCA) in human urine at a 1000 ng/ml cutoff concentration. Results are preliminary and require confirmation by GC/MS or HPLC.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• SureStep™ Drug Screen TCA Test (K981605)

Submission Summary (Full Text)

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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:<br>Contact Person:<br>E-mail: | 12330 Stowe Drive<br>Poway, CA 92064<br>Telephone: [phone]<br>Fax: [phone]<br>Naishu Wang, MD, Ph.D.<br>[e-mail] |
| Device Name | Trade Name: Instant-View™ TCA Urine Test<br>Common Name: Immunoassay, TCA Urine Test<br>Classification: Tricyclic antidepressant drugs test system<br>(21 CFR 862.3910) Class II | |
| Date of Summary<br>Preparation | November, 5, 2002 | |
| Predicate Device | SureStep™ Drug Screen TCA Test, Applied Biotech, Inc.,<br>K981605 | |
| Device Description | A one-step lateral flow chromatographic immunoassay. The<br>test strip in the device includes 1) a conjugate pad containing<br>colloidal gold coupled with mouse anti-TCA antibodies; 2)<br>nitrocellulose membrane containing a test line (T line) and a<br>control line (C line). The Test line is coated with TCA- BSA,<br>and the Control line is coated with goat anti-mouse IgG<br>antibody. | |
| Summary of the<br>Similarity to the<br>Predicate Device | • Both are one-step lateral-flow chromatographic<br>immunoassay.<br>• Both are intended to provide qualitative detection of<br>Tricyclic Antidepressants at 1000 ng/ml, the cutoff level.<br>• Both are based on the similar mechanism of competitive<br>binding immunoassay.<br>• Both use a C line as built-in control to indicate that an<br>appropriate volume of sample is applied and whether the<br>device functions properly<br>• Both provide a preliminary result and need to be confirmed<br>with a more solid reference method, e.g. GC/MS or HPLC. | |
| Intended Use | This device is a one-step immunoassay intended to provide<br>qualitative rapid detection of tricyclic antidepressants (TCA)<br>at a cutoff level of 1000 ng/ml in human urine. It is for health<br>care professional use only. | |
| Accuracy studies | The accuracy of the device was evaluated with 80 clinical<br>urine samples calibrated with GC/MS. The negative results<br>agreed 96.7% (58/60). The positive results agreed 100%<br>(20/20). The overall accuracy was 97.5%. | |
| Reproducibility<br>studies | The reproducibility of this device was studied at three<br>Physician's Office Laboratories (POL) and one reference<br>laboratory. Evaluations were performed by personnel with<br>diverse educational backgrounds and working experiences.<br>The results from the four evaluation sites agreed 99%,<br>indicating a high reproducibility of the device. | |
| Specificity studies | Instant-View™ TCA Urine Test has positive responses to<br>structurally related compounds, Amitriptyline, Desipramine,<br>Imipramine, Nortriptyline, and Nordoxepine, at a<br>concentration of 1000 ng/ml; to Cyclobenzaprine,<br>Protriptyline, and Trimipramine at a concentration higher than<br>1500 ng/ml; to Doxepine and Clomipramine at a<br>concentration higher than 3000 ng/ml. No significant<br>interference observed with this device by the structurally<br>unrelated compounds tested at a concentration of 1 mg/ml. | |
| Conclusion | The results of accuracy, reproducibility, and specificity<br>studies demonstrate that the Instant-View™ TM TCA Urine Test is<br>substantially 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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#### Page 2

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 [phone]. 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 [phone] or [phone] 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.

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.

(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)

OR

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

Sean Cooper

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