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K Number
K061841
Device Name
QUANTA LITE INTRINSIC FACTOR ELISA
Manufacturer
INOVA DIAGNOSTICS, INC.
Date Cleared
2006-12-22

(176 days)

Product Code
LIG
Regulation Number
862.1810
Type
Traditional
Panel
IM
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The QUANTA Lite™ Intrinsic factor ELISA is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of Intrinsic factor antibodies in human serum. The presence of Intrinsic factor antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of pernicious anemia.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification approval letter for the "QUANTA Lite™ Intrinsic Factor ELISA" device. It does not contain information about acceptance criteria, a specific study, or detailed performance metrics. The document only specifies the device name, its indications for use, and confirms its substantial equivalence to a legally marketed predicate device.

Therefore, I cannot provide the requested information from this document. It lacks data on:

  1. Acceptance criteria and reported device performance: No such table is present.
  2. Sample size and data provenance: Not mentioned.
  3. Number and qualifications of experts for ground truth: Not mentioned.
  4. Adjudication method for the test set: Not mentioned.
  5. MRMC comparative effectiveness study or effect size: Not applicable as this is an in-vitro diagnostic test, not an AI-assisted imaging device.
  6. Standalone performance (algorithm only): Not applicable as this is an ELISA kit.
  7. Type of ground truth used: Not specified.
  8. Sample size for the training set: Not mentioned.
  9. How ground truth for the training set was established: Not mentioned.

§ 862.1810 Vitamin B

12 test system.(a)
Identification. A vitamin B12 test system is a device intended to measure vitamin B12 in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.(b)
Classification. Class II.