(154 days)
The Immunalysis Cocaine ELISA Kit for Hair test system utilizes an Enzyme Linked Immunoassay (ELISA) for the qualitative detection of cocaine in head hair samples using a cutoff of 500 pg/mg (0.5 ng/mg) of hair for the purpose of identifying chronic cocaine use. This process has not been evaluated for use with hair specimens other than head. This in vitro diagnostic device is intended for clinical laboratory use only.
The Immunalysis Cocaine ELISA Kit for Hair test system provides only a preliminary analytical test result. For confirmation of the results, presumptive positives are analyzed using a gas chromatograph - mass spectrometer operating in electron impact mode and using deuterated internal standards. Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.
Immunalysis Cocaine ELISA Kit for Hair test system utilizes an Enzyme Linked Immunoassay (ELISA) for the qualitative detection of cocaine in head hair samples.
The provided text is a 510(k) premarket notification letter from the FDA for the "Immunalysis Cocaine ELISA Kit for Hair." It does not contain a detailed study report with the specific information requested.
Therefore, I cannot provide the complete answer based solely on the provided text. The document refers to the acceptance of a "substantial equivalence" determination but does not include the actual study data, acceptance criteria table, or details about ground truth establishment, expert qualifications, or sample sizes.
However, based on the limited information in the "Indications for Use" section, here's what can be inferred and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria Mentioned (Implicitly): The "Indications for Use" states a cutoff of 500 pg/mg (0.5 ng/mg) of hair for identifying chronic cocaine use. This cutoff itself acts as an implicit performance characteristic related to the device's ability to differentiate between positive and negative samples.
- Reported Device Performance: NOT PROVIDED. The document does not contain data on sensitivity, specificity, accuracy, or any false positive/negative rates.
2. Sample size used for the test set and the data provenance:
- NOT PROVIDED.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- NOT PROVIDED.
4. Adjudication method for the test set:
- NOT PROVIDED.
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:
- NO. This is an ELISA kit for detecting cocaine, not an AI imaging device. Therefore, an MRMC study with human readers assisting with AI is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- YES (Implied). ELISA kits are designed to operate in a standalone manner to provide a preliminary analytical test result. The term "algorithm" is not applicable in the same way as with AI, but the kit itself is the "standalone" diagnostic tool.
7. The type of ground truth used:
- Confirmatory Test (Explicitly Mentioned): "For confirmation of the results, presumptive positives are analyzed using a gas chromatograph - mass spectrometer operating in electron impact mode and using deuterated internal standards." This highly accurate analytical method (GC-MS) serves as the gold standard or ground truth to confirm the preliminary ELISA results.
8. The sample size for the training set:
- NOT PROVIDED.
9. How the ground truth for the training set was established:
- NOT PROVIDED, but likely similar to the test set. Given that GC-MS is used for confirmation of positive results from the ELISA, it is highly probable that similar confirmatory methods would have been used to establish the ground truth for any samples used in developing or "training" the ELISA kit's performance characteristics.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, with three stylized lines forming the body and wings.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 4 - 2005
Mr. Michael J. Vincent V.P. Operations Immunalysis Corporation 829 Towne Center Dr. Pomona, CA 91767
$
K050465 Re:
Trade/Device Name: Immunalysis Cocaine Elisa Kit for Hair Regulation Number: 21 CFR 862.3250 Regulation Name: Cocaine and cocaine metabolite test system Regulatory Class: Class II Product Code: DIO Dated: June 10, 2005 Received: June 17, 2005
Dear Mr. Vincent:
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).
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This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter mification. The FDA finding of substantial equivalence of your device to a legally premaince notificate 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, rr you desire specific into motion 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 I ou may 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. Benson
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
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Indications for Use
510(k) Number (if known): K050465
E=mc²
Device Name: IMMUNALYSIS COCAINE ELISA KIT FOR HAIR
Indications For Use:
"The Immunalysis Cocaine ELISA Kit for Hair test system utilizes an Enzyme Linked Immunoassay (ELISA) for the qualitative detection of cocaine in head hair samples using a cutoff of 500 pg/mg (0.5 ng/mg) of hair for the purpose of identifying chronic cocaine use. This process has not been evaluated for use with hair specimens other than head. This in vitro diagnostic device is intended for clinical laboratory use only.
The Immunalysis Cocaine ELISA Kit for Hair test system provides only a preliminary analytical test result. For confirmation of the results, presumptive positives are analyzed using a gas chromatograph - mass spectrometer operating in electron impact mode and using deuterated internal standards. Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained."
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Albert C.
Division Sign-Off
Office of In Vitro Diagnostic
Device Evaluation and Safety
10(k) K050465
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§ 862.3250 Cocaine and cocaine metabolite test system.
(a)
Identification. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.(b)
Classification. Class II (special controls). A cocaine and cocaine metabolite 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).