The ACON BZO One Step Benzodiazepines Test Strip and ACON BZO One Step Benzodiazepines Test Device are rapid chromatographic immunoassays for the qualitative detection of Benzodiazepines in human urine at a cut-off concentration of 300 ng/mL set relative to oxazepam, a major metabolite of benzodiazepines. They are intended for healthcare professionals including professionals at point of care sites.

Device Description

The ACON BZO One Step Benzodiazepines Test Strip and ACON BZO One Step Benzodiazepines Test Device are competitive binding, lateral flow immunochromatographic assays for the qualitative screening of Benzodiazepines in a urine sample. The test is based on the principle of antigen-antibody immunochemistry. It utilizes mouse monoclonal antibody to selectively detect elevated levels of Benzodiazepines in urine at a cut-off concentration of 300 ng/mL. 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 Benzodiazepines 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

{
  "acceptance_criteria": {
    "device_performance_table": [
      {
        "criterion": "ACON BZO One Step Benzodiazepines Test Strip vs. LifeSign Status DS™ BZO One-Step Benzodiazepines Test - Positive Agreement",
        "reported_performance": "90% (95% CI: 84% - 95%)"
      },
      {
        "criterion": "ACON BZO One Step Benzodiazepines Test Strip vs. LifeSign Status DS™ BZO One-Step Benzodiazepines Test - Negative Agreement",
        "reported_performance": "97% (95% CI: 93% - 99%)"
      },
      {
        "criterion": "ACON BZO One Step Benzodiazepines Test Strip vs. LifeSign Status DS™ BZO One-Step Benzodiazepines Test - Overall Agreement",
        "reported_performance": "94% (95% CI: 91% - 96%)"
      },
      {
        "criterion": "ACON BZO One Step Benzodiazepines Test Device vs. LifeSign Status DS™ BZO One-Step Benzodiazepines Test - Positive Agreement",
        "reported_performance": "90% (95% CI: 84% - 94%)"
      },
      {
        "criterion": "ACON BZO One Step Benzodiazepines Test Device vs. LifeSign Status DS™ BZO One-Step Benzodiazepines Test - Negative Agreement",
        "reported_performance": "97% (95% CI: 92% - 99%)"
      },
      {
        "criterion": "ACON BZO One Step Benzodiazepines Test Device vs. LifeSign Status DS™ BZO One-Step Benzodiazepines Test - Overall Agreement",
        "reported_performance": "94% (95% CI: 90% - 96%)"
      },
      {
        "criterion": "ACON BZO One Step Benzodiazepines Test Strip vs. GC/MS - Positive Agreement",
        "reported_performance": "97% (95% CI: 92% - 99%)"
      },
      {
        "criterion": "ACON BZO One Step Benzodiazepines Test Strip vs. GC/MS - Negative Agreement",
        "reported_performance": "95% (95% CI: 91% - 98%)"
      },
      {
        "criterion": "ACON BZO One Step Benzodiazepines Test Strip vs. GC/MS - Total Agreement",
        "reported_performance": "96% (95% CI: 93% - 98%)"
      },
      {
        "criterion": "ACON BZO One-Step Benzodiazepines Test Device vs. GC/MS - Positive Agreement",
        "reported_performance": "96% (95% CI: 92% - 98%)"
      },
      {
        "criterion": "ACON BZO One-Step Benzodiazepines Test Device vs. GC/MS - Negative Agreement",
        "reported_performance": "96% (95% CI: 92% - 99%)"
      },
      {
        "criterion": "ACON BZO One-Step Benzodiazepines Test Device vs. GC/MS - Total Agreement",
        "reported_performance": "96% (95% CI: 94% - 98%)"
      }
    ],
    "study_details": {
      "test_set_sample_size": 300,
      "data_provenance": "Clinical urine specimens, retrospective (implied by the nature of clinical evaluation and GC/MS retrospective analysis)",
      "number_of_experts_ground_truth": "Not specified, but the comparison is against another FDA-cleared device and Gas Chromatography/Mass Spectrometry (GC/MS) analysis, which serves as the gold standard.",
      "qualification_of_experts": "Not specified, as the ground truth is established by objective methods (GC/MS) and comparison to a predicate device.",
      "adjudication_method": "Not applicable, as the ground truth is established by objective methods (GC/MS) and comparison to a predicate device rather than human consensus.",
      "mrmc_comparative_effectiveness_study": "No, this was not a multi-reader multi-case (MRMC) comparative effectiveness study, as it did not involve human readers interpreting images with and without AI assistance.",
      "standalone_performance_study": "Yes, a standalone performance study was conducted comparing the device against Gas Chromatography/Mass Spectrometry (GC/MS) at the cutoff of 300 ng/ml. This represents the algorithm's (device's) performance without human intervention in the result interpretation.",
      "type_of_ground_truth_test_set": "Gas Chromatography/Mass Spectrometry (GC/MS) analysis at the cutoff of 300 ng/ml.",
      "training_set_sample_size": "Not specified in the provided document. The study describes a clinical evaluation using a test set, but does not detail the training set for the device's development.",
      "how_ground_truth_for_training_set_established": "Not specified in the provided document, as training data and how its ground truth was established are not described."
    }
  }
}

Summary

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SEP 1 7 2001

SUMMARY OF 510(k) SAFETY AND EFFECTIVENESS 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 K012300

Submitter:

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

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

Date:

July 16, 2001

Contact Person:

Edward Tung, Ph.D.

Product Names:

ACON® BZO One Step Benzodiazepines Test Strip

ACON® BZO One Step Benzodiazepines Test Device

Common Name:

Immunochromatographic test for the qualitative detection of Benzodiazepines in urine

Device Classification:

The ACON BZO One Step Benzodiazepines Test Strip and ACON BZO One Step Benzodiazepines Test Device are similar to other FDA-cleared devices for the qualitative detection of Benzodiazepines in urine specimens. These tests are used to provide a preliminary analytical result. (21 CFR 862.3170) Benzodiazepines test systems have been classified as Class II devices with moderate complexity.

Classification Name:

Benzodiazepines test system

{1}------------------------------------------------

Intended Use:

The ACON® BZO One Step Benzodiazepines Test Strip and ACON BZO One Step Benzodiazepines Test Device are rapid chromatographic immunoassays for the qualitative detection of Benzodiazepines in urine at a cut-off concentration of 300 ng/mL set relative to Oxazepam. They are intended for healthcare professionals including professionals at point of care sites.

Description:

Predicate Device:

LifeSign Status DSTM BZO One-Step Benzodiazepines Test

510(k) Number: K991079

Comparison to a Predicate Device:

A comparison of the features of the ACON BZO One Step Benzodiazepines Test Strip and ACON BZO One Step Benzodiazepines Test Device versus the LifeSign Status DSTM BZO One-Step Benzodiazepines Test is shown below:

. Both tests are assays intended for the qualitative detection of Benzodiazepines 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 Benzodiazepines with a visual, qualitative end result.
8 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 Benzodiazepines concentration of 300 ng/mL. .

{2}------------------------------------------------

Safety and Effectiveness Data:

Accuracy

A clinical evaluation was conducted using 300 clinical urine specimens including 10% of the samples with benzodiazepine concentrations at -25% cut-off to +25% cut-off range. This evaluation compared the test results between ACON® BZO One Step Benzodiazepines Test Strip and Test Device with LifeSign Status DSTM BZO One-Step Benzodiazepines Test; as well as against data obtained from the customary Gas Chromatography/Mass Spectrometry analysis. The comparisons of data obtained from this study yielded the following results:

ACON BZO One Step Benzodiazepines Test Strip versus the LifeSign Status DSTM BZO One- Step Benzodiazepines Test:

Positive Agreement: 131 / 145 = 90% (84% - 95%) Negative Agreement: 149 / 153 = 97% (93% - 99%") Overall Agreement: 280 / 298 = 94% (91% - 96%) * 95% Confidence Intervals

ACON BZO One Step Benzodiazepines Test Device versus the LifeSign Status DS™ BZO One-Step Benzodiazenines Test:

Positive Agreement: 130 / 144 = 90% {84% - 94%* } Negative Agreement: 149 / 154 = 97% (92% - 99%) Overall Agreement: 279 / 298 = 94% (90% -96%) * 95% Confidence Intervals

ACON BZO One Step Benzodiazepines Test Strip versus GC/MS at the cutoff of 300 ng/ml:

Positive agreement with GC/MS: 131 / 135 = 97% (92% - 99%) Negative agreement with GC/MS: 157 / 165 = 95% (91% - 98%) Total agreement with GC/MS: 288 / 300 = 96% (93% - 98%*) * 95% confidence intervals

ACON BZO One-Step Benzodiazepines Test Device versus GC/MS at the cutoff of 300 ng/ml.

Positive agreement with GC/MS: 130 / 135 = 96% (92% - 98%) Negative agreement with GC/MS: 159 / 165 = 96% (92% - 99%) Total agreement with GC/MS: 289 / 300 = 96% (94% - 98%*) * 95% confidence intervals

Conclusion:

These clinical studies demonstrate the substantial equivalency between the ACON BZO One Step Benzodiazepines Test Strip, ACON BZO One Step Benzodiazepines Test Device and the LifeSign Status DSTM BZO One-Step Benzodiazepines Test, which has already being marketed in the United States. It is also demonstrated that these tests are safe and effective in detecting Benzodiazepines at a concentration of 300 ng/mL. The POL study demonstrated that these tests are suitable for professional and point-of-care use.

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name in a circular arrangement around a stylized symbol. The symbol consists of four abstract shapes that resemble human profiles and waves, representing the department's focus on health and human well-being. The seal is in black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 1 7 2001

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

K012300 Re:

K012500
Trade/Device Name: ACON BZO One Step Benzodiazepines Test Strip ACON BZO One Step Benzodiazepines Test Device Regulation Number: 21 CFR 862.3170 Regulation Name: Benzodiazepine test system Regulatory Class: Class II Product Code: JXM Dated: July 16, 2001 Received: July 20, 2001

Dear Dr. Tung:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becalling is the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the encreativent of the enactment date of the Medical Device Amendments, or to comments problem to May 20, 1976, are excordance with the provisions of the Federal Food, Drug, devices may been recalismed in assess asproval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The 1 ou may, therefore, market the act include requirements for annual registration, listing of gencial controls provisions of the rice, 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 (socure) into existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations FDA wo inay be subject to subli additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oous cevents concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Frease be advised that I DT 3 lossantes of our device complies with other requirements of the Act that IDA has made a dolorimiation administered by other Federal agencies. You must of any I ederal statutes and regulations and limited to: registration and listing (21 compry with an the rice srequirements, and manufacturing practice requirements as set CITY at 807), adomig (21 OFR Part 820), and if applicable, the electronic form in the quality systems (Sections (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 Butman

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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10. INDICATIONS FOR USE

K012300 510(k) Number:

Device Name: ACON® BZO One Step Benzodiazepines Test Strip

ACON® BZO One Step Benzodiazepines Test Device

Indications for Use:

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

Prescription Use

(Per 21 CFR 801.109)

Over-The-Counter Use

Kesia Alexander for Joan Cooper
(Division Sign-Off)

Division of Clinical Laboratory Devices

510(k) Number K012300

Regulation Number and Section

§ 862.3170 Benzodiazepine test system.

(a)
Identification. A benzodiazepine test system is a device intended to measure any of the benzodiazepine compounds, sedative and hypnotic drugs, in blood, plasma, and urine. The benzodiazepine compounds include chlordiazepoxide, diazepam, oxazepam, chlorzepate, flurazepam, and nitrazepam. Measurements obtained by this device are used in the diagnosis and treatment of benzodiazepine use or overdose and in monitoring levels of benzodiazepines to ensure appropriate therapy.(b)
Classification. Class II (special controls). A benzodiazepine 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).