REFERENCE MATERIAL FOR AMPHETAMINE/METHAMPHETAMINE IN HUMAN URINE

• K Number: K974699
• Device Name: REFERENCE MATERIAL FOR AMPHETAMINE/METHAMPHETAMINE IN HUMAN URINE
• Manufacturer: CONSOLIDATED TECHNOLOGIES, INC.
• Date Cleared: 1998-01-22 ( 37 days)
• Product Code: DKB
• Regulation Number: 862.3200
• Type: Traditional
• Panel: TX
• Reference & Predicate Devices: N/A

Intended Use

Reference Material for Amphetamine/Methamphetamine in Human Urine is a material intended for use in verifying the accuracy of GC/MS methods used for quantitation of this analyte and imetabolite in human urine.

Device Description

Reference Material for Amphetamine/Methamphetamine in Human Urine

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a diagnostic reference material, not an AI device. As such, it does not contain the information requested in your prompt regarding acceptance criteria and a study proving an AI device meets these criteria.

The document discusses:

• The FDA's determination of substantial equivalence for a "Reference Material for Amphetamine/Methamphetamine in Human Urine."
• Regulatory classifications and general controls for medical devices.
• Requirements under CLIA-88 (Clinical Laboratory Improvement Amendments of 1988).
• Contact information for various FDA departments.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
6. If a standalone (algorithm only) performance study was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

Regulation Number and Section

§ 862.3200 Clinical toxicology calibrator.

(a)
Identification. A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). 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.