The ACON TCA One Step Tricyclic Antidepressants Test Strip and ACON TCA One Step Tricyclic Antidepressant Test Device are rapid chromatographic immunoassays for the qualitative detection of Tricyclic Antidepressants in human urine at a cut-off concentration of 1,000 ng/mL in reference to Nortriptyline. They are intended for Healthcare professionals including professionals at the point-of-care sites.

Device Description

The ACON TCA One Step Tricyclic Antidepressant Test Strip and ACON TCA One Step Tricyclic Antidepressant Test Device are competitive binding, lateral flow immunochromatographic assays for the qualitative screening of Tricyclic Antidepressant in a urine sample. The test is based on the principle of antigen-antibody immuncchemistry. It utilizes mouse monoclonal antibody to selectively detect elevated levels of Tricyclic Antidepressant in urine at a cut-off concentration of 1000 ng/mL for Nortriptyline. These tests can be performed without the use of an instrument.

A drug-positive urine specimen will not generate a colored-line in the designated test region, while a negative urine specimen or a urine specimen containing Tricyclic Antidepressant at the concentration below the cut-off level will generate a colored-line in the test region. To serve as a procedural control. a colored-line will always appear at the control region, indicating that proper volume of specimen has been added and membrane wicking has occurred.

AI/ML Overview

Here's an analysis of the provided text, outlining the acceptance criteria and study details for the ACON TCA One Step Tricyclic Antidepressant Test Strip and Device:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a numerical target format (e.g., "Positive Agreement > 90%"). However, it reports performance metrics against a predicate device and a reference method, implying these reported values demonstrate acceptable performance for substantial equivalence.

Performance Metric (vs. Predicate Device: Status DSTM One Step Tricyclic Antidepressants Test)	ACON TCA Test Strip Performance	ACON TCA Test Device Performance
Positive Agreement (95% CI)	95% (86% - 99%)	95% (86% - 99%)
Negative Agreement (95% CI)	100% (98% - 99%)	100% (98% - 99%)
Overall Agreement (95% CI)	99% (96% - 99%)	99% (96% - 99%)

Performance Metric (vs. Reference Method: HPLC at 1,000 ng/mL cutoff)	ACON TCA Test Strip Performance	ACON TCA Test Device Performance
Agreement for Negative (Drug-free urine)	100% (150/150)	100% (150/150)
Agreement for Negative (<-25% cutoff)	0% (0/17) - Incorrectly reported as "Negative", should be Positive	0% (0/17) - Incorrectly reported as "Negative", should be Positive
Agreement for Negative (-25% cutoff to cutoff)	0% (0/12) - Incorrectly reported as "Negative", should be Positive	0% (0/12) - Incorrectly reported as "Negative", should be Positive
Agreement for Positive (Cutoff to +25% cutoff)	100% (15/15)	100% (15/15)
Agreement for Positive (>+25% cutoff)	100% (20/20)	100% (20/20)
% Agreement (Negative)	89% (84% - 93%)*	89% (84% - 93%)*
% Agreement (Positive)	>99% (90% - 99%)*	>99% (90% - 99%)*
Note: The tables for HPLC comparison in the original document seem to have a mixed interpretation of "Negative" and "Positive" agreement, particularly for the categories around the cutoff. The data presented indicates the device accurately identified true negatives (drug-free) and true positives (> +25% cutoff).

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

Sample Size: 226 clinical urine specimens.
- This included "over 10% of the samples with Antidepressants concentrations at -25% cut-off to +25% cut-off range."
Data Provenance: The document does not explicitly state the country of origin. It mentions "clinical urine specimens," which implies human-derived data. The study is a "clinical evaluation," typically prospective in nature, as it compares new devices to existing methods. However, it doesn't explicitly state "retrospective" or "prospective."

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

There is no mention of experts being used to establish ground truth for the test set.

4. Adjudication Method for the Test Set

There is no mention of an adjudication method. The ground truth was established by comparison to the predicate device and High-Performance Liquid Chromatography (HPLC).

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

No, an MRMC comparative effectiveness study was not done. This study is for an in vitro diagnostic (IVD) device, which typically does not involve human readers interpreting results in the same way imaging AI does. The device produces a visual, qualitative result (colored line or no colored line).

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

Yes, the performance presented in the "ACON TCA One Step Tricyclic Antidepressant Test Strip versus HPLC" and "ACON TCA One Step Tricyclic Antidepressant Test Device versus HPLC" tables represents the standalone performance of the device. The device's output (presence/absence of a line) is directly compared to the reference standard (HPLC). There is no "human-in-the-loop" interpretation beyond observing the presence or absence of a line.

7. The Type of Ground Truth Used

The ground truth was established by two methods:

Comparison to a legally marketed predicate device: Status DSTM One Step Tricyclic Antidepressants Test.
Reference method: Customary High-Performance Liquid Chromatography (HPLC) analysis, which is an established laboratory method for drug quantification.

8. The Sample Size for the Training Set

There is no mention of a separate training set or its sample size. For these types of immunoassay devices, the development process might involve internal validation and optimization, but a distinct "training set" like in machine learning is not typically detailed in 510(k) submissions unless it's an AI-driven diagnostic.

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

As no training set is explicitly mentioned or detailed, there is no information on how its ground truth was established.

Summary

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SUMMARY OF 510(k) 8.

This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The Assigned 510(k) number is ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Submitter:

ACON Laboratories, Inc. 4108 Sorrento Valley Boulevard San Diego, California 92121

Tel .: 858-535-2030 Fax: 858-535-2038

Date:

May 8, 2002

Contact Person:

Edward Tung, Ph.D.

Product Names:

ACON® TCA One Step Tricyclic Antidepressant Test Strip

ACON® TCA One Step Tricyclic Antidepressant Test Device

Common Name:

Immunochromatographic test for the qualitative detection of Tricyclic Antidepressant in urine

Device Classification:

The ACON TCA One Step Tricyclic Antidepressant Test Strip and ACON TCA One Step Tricyclic Antidepressant Test Device are similar to other FDA-cleared devices for the qualitative detection of Tricyclic Antidepressant in urine specimens. These tests are used to provide a preliminary analytical result. Tricyclic Antidepressant test systems have been classified as Class II devices with moderate complexity. The product code for these devices is LFG and the regulation number is 862.3910.

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Classification Name:

Tricyclic Antidepressant test system

Intended Use:

The ACON® TCA One Step Tricyclic Antidepressant Test Strip and ACON TCA One Step Tricyclic Antidepressant Test Device are rapid chromatographic immunoassays for the qualitative detection of Tricyclic Antidepressant in urine at a cut-off concentration of 1,000 ng/mL in reference to Nortriptyline. They are intended for healthcare professionals at point-of-care sites. 23-1-1-1-1

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Description:

Predicate Device:

Status DSTM TCA One step Tricyclic Antidepressants Test

510(k) Number: K980249

Comparison to a Predicate Device:

A comparison of the features of the ACON TCA One Step Tricyclic Antidepressant Test Strip and ACON TCA One Step Tricyclic Antidepressant Test Device versus the Status™ One step Antidepressants Test is shown below:

Both tests are assays intended for the qualitative detection of Tricyclic Antidepressant in urine . samples.
. Both tests are intended as a screening method that provides a preliminary analytical test result.
. Both tests are immunochromatographic, lateral flow assays for the rapid detection of Tricyclic Antidepressant with a visual, qualitative end result.

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Both tests utilize the same basic immunoassay principles that rely on antigen/ antibody . interactions to indicate a positive or negative result.
Both tests have a cut-off for Nortriptyline concentration of 1,000 ng/mL. .

Safety and Effectiveness Data:

Accuracy

A clinical evaluation was conducted using 226 clinical urine specimens including over 10% of the samples with Antidepressants concentrations at -25% cut-off to +25% cut-off range. This evauation compared the test results between ACON® TCA One Step Tricyclic Antidepressants Test Strip and Test Device with Status DS™ One Step Tricyclic Antidepressants Test; as well as against data obtained from the customary HPLC analysis. The comparisons of data obtained from this study yielded the following results:

ACON TCA One Step Tricyclic Antidepressant Test Strip versus the Status DSTM One Step Tricyclic Antidepressants Test:

Positive Agreement: 55 / 58 = 95% (86% - 99%) Negative Agreement: 164 / 164 = 100% (98% - 99%) Overall Agreement: 219 / 222 = 99% (96% - 99 %*) * 95% Confidence Intervals

ACON TCA One Step Tricyclic Antidepressant Test Device versus the Status DSTM One Step Tricyclic Antidepressant Test:

Positive Agreement: 55 / 58 = 95% (86% - 99%) Negative Agreement: 164 / 164 = 100% (98% - 99%) Overall Agreement: 219 / 222 = 99% (96% - 99 %*) * 95% Confidence Intervals

ACON TCA One Step Tricyclic Antidepressant Test Strip versus HPLC at the cutoff of 1,000 ng/ml:

AconTCA teststrip	Drug -free urine	<-25%cutoff	-25% cutoffto cutoff	Cutoff to+25% cutoff	>+25%cutoff	% agreement
Negative	150	17	0	0	0	89%(84% - 93%)*
Positive	0	12	8	15	20	>99%(90% - 99%)*

95% Confidence Intervals

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AconTCA testDevice	Drug - freeurine	<-25%cutoff	-25% cutoffto cutoff	Cutoff to+25% cutoff	>+25%cutoff	% agreement
Negative	150	17	0	0	0	89%(84% - 93%)*
Positive	0	12	8	15	20	>99%(90% 99%)*

ACON TCA One-Step Tricyclic Antidepressant Test Device versus HPLC at the cutoff of 1,000 ng/ml:

· 95% Confidence Intervals

Conclusion:

These clinical studies demonstrate the substantial equivalency between the ACON TCA One Step Tricyclic Antidepressant Test Strip, ACON TCA One Step Tricyclic Antidepressant Test Device and the Status DSTM One Step Tricyclic Antidepressant Test, which has already being marketed in the United States. It is also demonstrated that these tests are safe and effective in detecting Tricyclic Antidepressant at a concentration of 1,000 ng/mL. The POL study demonstrated that these tests are suitable for healthcare professionals including professionals at point-of-care site.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings and a wavy line representing its body.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 1 7 2002

Edward Tung, Ph.D. Director of Regulatory Affairs ACON Laboratories, Inc. 4108 Sorrento Valley Blvd. San Diego, CA 92121

Re: K021526

Trade/Device Name: ACON® TCA One Step Tricyclic Antidepressants Test Strip ACON® TCA One Step Tricyclic Antidepressants Test Device Regulation Number: 21 CFR 862.3910 Regulation Name: Tricyclic antidepressant drugs test system Regulatory Class: Class II Product Code: LFG Dated: May 8, 2002 Received: May 10, 2002

Dear Dr. Tung:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrb/dsma/dsmamain.html".

Sincerely yours,

Steven Putman

Steven I. Gutman, M.D., M.B.A. - -Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K021526

INDICATIONS FOR USE 10.

510(k) Number:

Koals Ble

Device Name: ACON® TCA One Step Tricyclic Antidepressants Test Strip

ACON® TCA One Step Tricyclic Antidepressants Test Device

德 12/200

Indications for Use:

Sean Cooper

(Division Sign-Off)
Division of Clinical Laboratory Devices

Division of Clinical Laboratory Devices
510(k) Number K021526

(Please do not write below this point) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ V (Per 21 CFR 801.109)

Over-The-Counter Use Or

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).