The Rapid Reader System is designed to read , capture, document and archive ABMC's Rapid Drug Screen®, Rapid One®, and Rapid TEC® screening immunoassays ("ABMC test"). The Rapid Reader is used to obtain qualitative results (equivalent to manual read test results) and is intended for professional and point of care use only. It is not intended for over the counter sale to non-professionals. This Reader, combined with ABMC tests is a simplified qualitative screening method that provides only a preliminary result for use in determining the need for additional or confirmatory testing, i.e., gaschromatography/mass spectrometry (GC/MS).

The Rapid Reader System is a reader designed to capture, document and archive ABMC Drug of abuse test results using Rapid Drug Screen®, Rapid One®, and Rapid TEC® screening immunoassays ("ABMC tests"). The Rapid Reader is used to obtain qualitative results and is intended for professional use only. This Reader, combined with ABMC tests is a simplified qualitative screening method that provides a preliminary indication of drugs in urine. Results should be confirmed using appropriate confirmation methods. i.e., gas-chromatography/mass spectrometry (GC/MS).

Device Description

The Rapid Reader utilizes a digital camera, pictures are analyzed using software algorithm developed to read any of American Bio Medica Corporation's (ABMC's) drugs of abuse screening immunoassays. These immunoassays include the Rapid Drug Screen®, Rapid One®, or Rapid TEC® drug of abuse test for the simultaneous detection of up to 10 drugs of abuse in human urine. All of these tests have been previously FDA cleared as Class II devices.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Correctly identified drug-free specimens as negative (equivalent to manual interpretation).	The Rapid Reader interpretation and manual interpretation correctly identified 100% of drug-free specimens as negative.
Correctly identified specimens containing drug at a concentration above cutoff as positive (equivalent to manual interpretation).	The Rapid Reader interpretation and manual interpretation correctly identified 100% of specimens containing drug at a concentration above the cutoff level for each of the 14 drugs of abuse as positive.
Qualitative results equivalent to manual read test results.	The study implicitly demonstrates this by showing 100% concordance with manual interpretation for both negative and positive results across all tested drugs. The conclusion states: "The evaluation has led to the assurance that the performance of the Rapid Reader in correctly interpreting the ABMC test result is equivalent to the performance of reading the test manually."

Study Details:

Sample size used for the test set and the data provenance: Not explicitly stated. The text mentions "Certified negative and positive controls for each of the 14 drugs of abuse were tested," suggesting a set of controlled samples. The provenance (country of origin, retrospective/prospective) is not specified, but the study inherently appears prospective in nature as it describes an evaluation being conducted.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Three "untrained professionals" performed the manual interpretation which served as the reference for comparison. Their specific qualifications beyond "untrained professionals" are not provided.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not explicitly stated, but the process implies direct comparison of the Rapid Reader's output to the manual interpretation by the three "untrained professionals." It's not clear if there was a formal adjudication process if these three professionals disagreed amongst themselves.
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: No, an MRMC comparative effectiveness study, in the typical sense of measuring human reader improvement with AI assistance, was not performed. This study compared the device (Rapid Reader) against manual human interpretation, not human readers with and without AI assistance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Yes, the described study is a standalone performance evaluation. The Rapid Reader generated results independently, which were then compared to human manual interpretation.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth was established by "manual interpretation (human eye interpretation)" performed by three "untrained professionals," combined with the use of "certified negative and positive controls" for each drug. This is a form of expert consensus/reference standard.
The sample size for the training set: Not provided. The document focuses exclusively on the performance evaluation of the Rapid Reader, not its development or training data.
How the ground truth for the training set was established: Not provided.

Summary

{0}------------------------------------------------

K041696

Pre-market 510(k) Notification JUL 1 2 2005 Rapid Reader

American Bio Medica Corporation

Page 2-1

PREMARKET NOTIFICATION 510(k) SUMMARY

This 510(k) information required in 21 C.F.R.§ 807.87 for a 510(k) premarket notification is itemized below:

Date Prepared: June 15, 2004

Applicant: American Bio Medica Corporation 122 Smith Road Kinderhook, NY 12106

Fran White, MDC Associates Contact: 163 Cabot Street, Beverly, MA Phone: 978 927 3808 Fax: 978 927 1308 E-mail: Fran(a)mdcassoc.com

1. Device Trade Name: Rapid Reader™
1. Common Name: Densitometer/scanner
1. Classification Name: Densitometer/scanner (Integrating, Reflectance, TLC, Radiochromatogram) for clinical use
1. Device Description: The Rapid Reader utilizes a digital camera, pictures are analyzed using software algorithm developed to read any of American Bio Medica Corporation's (ABMC's) drugs of abuse screening immunoassays. These immunoassays include the Rapid Drug Screen®, Rapid One®, or Rapid TEC® drug of abuse test for the simultaneous detection of up to 10 drugs of abuse in human urine. All of these tests have been previously FDA cleared as Class II devices.
1. Intended Use: The Rapid Reader System is designed to read , capture, document and archive ABMC's Rapid Drug Screen®, Rapid One®, and Rapid TEC® screening immunoassays ("ABMC test"). The Rapid Reader is used to obtain qualitative results (equivalent to manual read test results) and is intended for professional and point of care use only. It is not intended for over the counter sale to non-professionals. This Reader, combined with ABMC tests is a simplified qualitative screening method that provides only a preliminary result for use in determining the need for additional or confirmatory testing, i.e., gaschromatography/mass spectrometry (GC/MS).

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

K041696

Pre-market 510(k) Notification Rapid Reader

Page 2-2 American Bio Medica Corporation

After performing an ABMC test (according to instructions for use for each ABMC test) the test is inserted into the device holder of the Rapid Reader. The Rapid Reader reads the test device, and the results are displayed as a "POSITIVE", "NEGATIVE", or "INVALID" generating a result for each individual drug test on the ABMC test device being used.

1. Substantial Equivalence: The Rapid Reader test system is substantially equivalent to BioSite Inc.'s Triage® Meter.

ProductAttribute	Triage Meter (K973547)	Rapid Reader	SubstantiallyEquivalent
Intended Use	Determines qualitativepositive or negative resultfrom drug of abuseimmunoassays screens	Determines qualitativepositive or negative resultfrom drug of abuseimmunoassay screens	✓
MeasurementMethod	Reads the results generatedby the test device(Triage Test)	Reads the results generated bythe test device(Rapid Drug Screen, RapidOne, or Rapid TEC)	✓
Output	Outputs “Positive” or“Negative” qualitative testresult and provides a printout of test result comparableto a manual read test result.	Outputs “Positive” or“Negative” qualitative testresult and provides a print outof test results comparable to amanual read test result. .	✓

1. Summary of Comparison Data: The Rapid Reader interpretation of results was compared to manual interpretation (human eye interpretation) of ABMC's Rapid One devices. Certified negative and positive controls for each of the 14 drugs of abuse were tested using ABMC's Rapid One assay. Testing was conducted by three untrained professionals. The results were read in accordance with defined procedures then test devices were read using two ABMC Rapid Readers. Results generated by the reader were compared to manual test results.
- The Rapid Reader and manual interpretation correctly identified 100% of drug . free specimens as negative.
- The Rapid Reader and manual interpretation correctly identified 100% of . specimens containing drug at a concentration above the cutoff level for each of the 14 drugs of abuse as positive.
1. Conclusion: The design control process led to a determination that the Rapid Reader is substantially equivalent to the previously cleared predicate device. The evaluation has led to the assurance that the performance of the Rapid Reader in correctly interpreting the ABMC test result is equivalent to the performance of reading the test manually.

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized representation of a human figure, with three overlapping profiles suggesting a family or community. The figure is abstract and uses curved lines to create a sense of movement and connection.

JUL 12 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

American Bio Media Corp. c/o Ms. Fran White MDC Associates 163 Cabot Street Beverly, MA 01915

Re: K041696 Trade/Device Name: Rapid Reader™ Regulation Number: 21 CFR 862.3150 Regulation Name: Barbiturate test system Regulatory Class: Class II Product Code: DKZ, DIS, JXM, LDJ, DIO, DJC, DJR, DPK, DJG, LCM, JXN, LFG, KHO Dated: June 16, 2005 Received: June 17, 2005

Dear Ms. White:

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.

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).

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

Page 2 -

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 (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours,

Carol C. Benem

Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

STATEMENT OF INDICATIONS FOR USE:

14041696 510(k) Number:

Device Name: Rapid Reader™

Indications For Use:

After having performed the ABMC tests (according to instructions for use of each ABMC tests) the ABMC test is inserted into the device holder of the Rapid Reader. The Rapid Reader scans the device, and the results are displayed.

The performance characteristics of the device have not been determined for use at point of care. This statement of intended use will be included in the operation manual.

Albert Sals
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K041696

Prescription Use ✔ (Per 21 CFR 801 Subpart D)

Over The Counter Use (21 CFR 807 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Regulation Number and Section

§ 862.3100 Amphetamine test system.

(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine 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).