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K Number
K052262
Device Name
QUANTA LITE M2 EP (MIT3) ELISA
Manufacturer
INOVA DIAGNOSTICS, INC.
Date Cleared
2005-10-27

(69 days)

Product Code
DBM
Regulation Number
866.5090
Type
Traditional
Panel
IM
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The QUANTA Lite™ M2 EP (MIT3) ELISA is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of mitochondrial antibodies in human serum. The presence of mitochondrial antibodies can be used in conjunction with clinical findings to aid in the diagnosis of primary biliary cirrhosis.

Device Description

The QUANTA Lite™ M2 EP (MIT3) ELISA is an enzyme-linked immunosorbent assay (ELISA)

AI/ML Overview

The provided document is a 510(k) premarket notification letter from the FDA regarding the QUANTA Lite™ M2 EP (MIT3) ELISA device. While it states that the device is substantially equivalent to a predicate device, it does not contain the detailed study information needed to answer the questions about acceptance criteria and device performance.

Specifically, the document only provides:

  • Device Name: QUANTA Lite™ M2 EP (MIT3) ELISA
  • Intended Use: Semi-quantitative detection of mitochondrial antibodies in human serum to aid in the diagnosis of primary biliary cirrhosis.
  • Regulatory Classification: Class II, Product Code DBM.

The document does NOT include any information on:

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

To obtain this information, one would typically need to review the full 510(k) submission (not just the FDA's decision letter), which includes the detailed analytical and clinical performance studies conducted by the manufacturer.

§ 866.5090 Antimitochondrial antibody immunological test system.

(a)
Identification. An antimitochondrial antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the antimitochondrial antibodies in human serum. The measurements aid in the diagnosis of diseases that produce a spectrum of autoantibodies (antibodies produced against the body's own tissue), such as primary biliary cirrhosis (degeneration of liver tissue) and chronic active hepatitis (inflammation of the liver).(b)
Classification. Class II (performance standards).