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K Number
K122066
Device Name
HUMAN BETA-2 MICROGLOBULIN URINE KIT FOR USE ON THE SPAPLUS
Manufacturer
THE BINDING SITE GROUP LTD
Date Cleared
2012-08-30

(45 days)

Product Code
JZG
Regulation Number
866.5630
Type
Special
Panel
IM
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The kit is intended for the quantitative in vitro determination of beta-2 microglobulin (β2M) in human unne using the SPAPLUS analyser, to aid the diagnosis of active rheumatoid arthritis and kidney disease. The test result is to be used in conjunction with other clinical and laboratory findings

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) premarket notification letter for the "Human Beta-2 Microglobulin Kit for use on SPAplus™". It discusses the regulatory approval of the device but does not contain information about the acceptance criteria or the study that proves the device meets those criteria.

The letter confirms that the FDA has determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It outlines regulatory requirements but does not include:

  1. A table of acceptance criteria and reported device performance.
  2. Sample size used for the test set and data provenance.
  3. Number of experts and their qualifications for ground truth establishment.
  4. Adjudication method for the test set.
  5. Information on any multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
  6. Details about standalone (algorithm only) performance.
  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.

Therefore, I cannot answer the specific questions based on the provided text. The document is primarily a regulatory approval letter, not a performance study report.

§ 866.5630

Beta -2-microglobulin immunological test system.(a)
Identification. Abeta -2-microglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniquesbeta -2-microglobulin (a protein molecule) in serum, urine, and other body fluids. Measurement ofbeta -2-microglobulin aids in the diagnosis of active rheumatoid arthritis and kidney disease.(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 § 866.9.