(385 days)
Not Found
No
The description mentions a "software algorithm developed to read" the immunoassays, but there is no mention of AI, ML, or any related concepts like training sets or complex learning processes. The performance study compares the reader's results to manual interpretation, which is typical for a standard image processing algorithm, not necessarily an AI/ML system.
No
The device is described as a system designed to read, capture, document and archive results from drug screening immunoassays. It provides only a preliminary result and is a simplified qualitative screening method for indicating drugs in urine. It is used to obtain qualitative results and results should be confirmed using appropriate confirmation methods. This functionality indicates it is a diagnostic tool, not a therapeutic one.
Yes
The Rapid Reader System is designed to read and interpret results from drug screening immunoassays, which are used to obtain qualitative results for the preliminary detection of drugs in urine. Although it provides only preliminary results that require confirmation, its function is to provide information about a patient's condition (presence of drugs), which is characteristic of a diagnostic device.
No
The device description explicitly states that the Rapid Reader utilizes a digital camera, which is a hardware component. The software analyzes pictures captured by this camera.
Based on the provided text, the Rapid Reader System is not an IVD (In Vitro Diagnostic) device itself.
Here's why:
- The core function of the Rapid Reader is to read and interpret the results of other devices. The text explicitly states it is designed to read ABMC's Rapid Drug Screen®, Rapid One®, and Rapid TEC® screening immunoassays.
- The IVD devices are the ABMC tests themselves. The text mentions that these immunoassays have been previously FDA cleared as Class II devices. These are the devices that perform the in vitro diagnostic test on the human urine sample.
- The Rapid Reader is a tool to assist in the interpretation of the IVD results. It provides a qualitative result equivalent to a manual read, but it doesn't perform the diagnostic test itself.
Think of it like this: The ABMC tests are the pregnancy test strips (the IVD). The Rapid Reader is a device that helps you read the lines on the pregnancy test strip more consistently or document the result. The reader itself isn't performing the chemical reaction that detects the pregnancy hormone.
Therefore, the Rapid Reader System is a reader or analyzer for IVD devices, but it is not an IVD device itself.
N/A
Intended Use / Indications for 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).
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.
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).
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.
Product codes (comma separated list FDA assigned to the subject device)
DKZ, DIS, JXM, LDJ, DIO, DJC, DJR, DPK, DJG, LCM, JXN, LFG, KHO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional and point of care use only. It is not intended for over the counter sale to non-professionals.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
-
- Device Trade Name: Rapid Reader™
-
- Common Name: Densitometer/scanner
-
- Classification Name: Densitometer/scanner (Integrating, Reflectance, TLC, Radiochromatogram) for clinical use
-
- 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.
-
- 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
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.
-
- Substantial Equivalence: The Rapid Reader test system is substantially equivalent to BioSite Inc.'s Triage® Meter.
| Product
Attribute | Triage Meter (K973547) | Rapid Reader | Substantially
Equivalent |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Intended Use | Determines qualitative
positive or negative result
from drug of abuse
immunoassays screens | Determines qualitative
positive or negative result
from drug of abuse
immunoassay screens | ✓ |
| Measurement
Method | Reads the results generated
by the test device
(Triage Test) | Reads the results generated by
the test device
(Rapid Drug Screen, Rapid
One, or Rapid TEC) | ✓ |
| Output | Outputs “Positive” or
“Negative” qualitative test
result and provides a print
out of test result comparable
to a manual read test result. | Outputs “Positive” or
“Negative” qualitative test
result and provides a print out
of test results comparable to a
manual read test result. . | ✓ |
-
- 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.
-
- 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:
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).
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)
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