K Number
K974181

Validate with FDA (Live)

Date Cleared
1997-12-11

(35 days)

Product Code
Regulation Number
862.3170
Age Range
All
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Immunoassay for the qualitative detection of Barbiturates, Benzodiazephines and/or their metabolites in human urine to assist in screening of drug of abuse samples and/or diagnosis of clinical symptoms associated with the use of drugs.

Device Description

Not Found

AI/ML Overview

The provided documents do not contain the specific details about acceptance criteria or a study proving the device meets those criteria, as typically found in a detailed submission for device clearance. This document is an FDA clearance letter for the AccuSign™ DOA 2(BAR/BZO) device, indicating that the FDA has determined it is "substantially equivalent" to previously marketed devices.

Therefore, I cannot provide information for most of your requested points. However, I can extract what is available:

1. A table of acceptance criteria and the reported device performance:

  • Not found in the provided text. The letter simply states the device is "substantially equivalent." Substantial equivalence is a regulatory standard, not a performance metric defined by specific acceptance criteria within this document.

2. Sample size used for the test set and the data provenance:

  • Not found in the provided text. This information would typically be in the 510(k) submission itself, not the clearance letter.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

  • Not found in the provided text.

4. Adjudication method for the test set:

  • Not found in the provided text.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

  • Not applicable and not found in the provided text. This device is an immunoassay for drug detection, not an AI-assisted diagnostic tool read by human readers.

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

  • Not applicable in the AI sense. This device is a qualitative immunoassay. The performance would be inherent to the test itself; there's no "algorithm only" performance separate from the human interpreting the test result (e.g., presence or absence of a line). Standalone performance in this context would refer to the device's accuracy in detecting the target substances. However, specific performance metrics (sensitivity, specificity, etc.) are not found in the provided text.

7. The type of ground truth used:

  • Not found in the provided text. For an immunoassay, the ground truth would typically be established by a more definitive laboratory method (e.g., GC/MS for drug detection).

8. The sample size for the training set:

  • Not applicable and not found in the provided text. This is not an AI/machine learning device that would have a "training set."

9. How the ground truth for the training set was established:

  • Not applicable and not found in the provided text.

Summary based on the provided FDA clearance letter:

The letter confirms the FDA has reviewed K974181 AccuSign™ DOA 2(BAR/BZO) and determined it is substantially equivalent to legally marketed predicate devices for the qualitative detection of Barbiturates, Benzodiazepines and/or their metabolites in human urine. The "Indications For Use" state it is "to assist in screening of drug of abuse samples and/or diagnosis of clinical symptoms associated with the use of drugs."

To get the detailed information you are requesting about performance criteria, study design, and data, you would typically need to review the full 510(k) submission (which is publicly available, but not included in these documents) for K974181.

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular emblem with the department's name encircling an abstract symbol. The symbol resembles a stylized caduceus, featuring a staff with a serpent entwined around it, representing health and medicine. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 1 1 1997

Kang, Ph.D. Jemo . Director Princeton BioMeditech Corporation P.O. Box 7139 Princeton, New Jersey 08543-7139

Re : K974181 AccuSign™ DOA 2(BAR/BZO) Regulatory Class: II Product Code: JXM Dated: December 3, 1997 Received: December 17, 1997

Dear Dr. Kang:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. ਮੈ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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

Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Litman

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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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 circular emblem with the department's name encircling an abstract symbol. The symbol resembles a stylized caduceus, featuring a staff with a serpent entwined around it, representing health and medicine. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 1 1 1997

Kang, Ph.D. Jemo . Director Princeton BioMeditech Corporation P.O. Box 7139 Princeton, New Jersey 08543-7139

Re : K974181 AccuSign™ DOA 2(BAR/BZO) Regulatory Class: II Product Code: JXM Dated: December 3, 1997 Received: December 17, 1997

Dear Dr. Kang:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. ਮੈ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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

Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Litman

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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K974181

510(K) Number (if Known):

Device Name: AccuSion_DOA_2_(BAR/B20)

Indications For Use:

Immunoassay for the qualitative detection of Barbiturates, Benzodiazephines and/or their metabolites in human urine to assist in screening of drug of abuse samples and/or diagnosis of clinical symptoms associated with the use of drugs.

vision Sign-Off)
vision of Clinical Laboratory Devices
510(k) Number. K97481

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Professional use (X)

Prescription Use X
(Per 21 CFR 801.109)

OR

(Tivisien Sign-Off) Division of Ciinical Laboratory Devices

510(k) Over The Counter Use

(Optional Format 1-2-96)

§ 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).