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K Number
K973316
Device Name
REP SPE VIS-60/40 KIT
Manufacturer
HELENA LABORATORIES
Date Cleared
1997-10-01

(28 days)

Product Code
CEF
Regulation Number
862.1630
Type
Traditional
Panel
CH
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

These kits are intended for separation and quantitations of serum proteins using agarose gel electrophoresis on the REP and REP 3 Analyzer.

This test can be useful in diagnosing various disease states which typically exhibit abnormal patterns. Examples of such diseases are inflammatory response, rheumatic fever, liver disease, protein-loss disorders, plasma cell dyscrasias and genetic deficiencies.

Device Description

Not Found

AI/ML Overview

I apologize, but the provided text is a 510(k) clearance letter from the FDA for a device, the REP SPE Vis-60/40 Kit, and does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria. The letter primarily states that the device is substantially equivalent to a pre-amendments device and can be marketed.

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

  1. A table of acceptance criteria and the reported device performance: This information is not present.
  2. Sample size used for the test set and the data provenance: Not mentioned.
  3. Number of experts used to establish the ground truth for the test set and their qualifications: Not mentioned.
  4. Adjudication method for the test set: Not mentioned.
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not mentioned.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned.
  7. The type of ground truth used: Not mentioned.
  8. The sample size for the training set: Not mentioned.
  9. How the ground truth for the training set was established: Not mentioned.

The 510(k) letter confirms the device's regulatory pathway and its intended use for "separation and quantitations of serum proteins using agarose gel electrophoresis on the REP and REP 3 Analyzer" to assist in diagnosing various disease states. However, it does not include the detailed performance study information you are asking for.

§ 862.1630 Protein (fractionation) test system.

(a)
Identification. A protein (fractionation) test system is a device intended to measure protein fractions in blood, urine, cerebrospinal fluid, and other body fluids. Protein fractionations are used as an aid in recognizing abnormal proteins in body fluids and genetic variants of proteins produced in diseases with tissue destruction.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.