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K Number
K970976
Device Name
CARDIOIMMUNE CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3
Manufacturer
MEDICAL ANALYSIS SYSTEMS, INC.
Date Cleared
1997-04-02

(16 days)

Product Code
JJY,75J
Regulation Number
862.1660
Type
Traditional
Panel
Clinical Chemistry
Reference & Predicate Devices
K961828
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Not Found

Device Description

Medical Analysis Systems CARDIOIMMUNE Cardiac Marker Control, Levels 1, 2 and 3 are ready-to-use liquid stable assayed control sera suitable for monitoring test procedures used in cardiac marker determinations. The controls are prepared from a human serum matrix with the addition of various constituents. Preservatives and stabilizers are added to maintain product integrity. The liquid matrix eliminates causes of vial to vial variability and, when handled as directed, provides consistency in day-to-day testing.

AI/ML Overview

This document is a 510(k) submission for a medical device (CARDIOIMMUNE Cardiac Marker Control, Levels 1, 2 and 3). It does not include information about acceptance criteria or a study proving the device meets acceptance criteria in the way you've described for an AI/ML powered medical device.

The document focuses on:

  • Establishing substantial equivalence to an existing device (LiquichekTM Cardiac Markers Control, K961828).
  • Describing the product's intended use (monitoring test procedures for cardiac marker determinations).
  • Providing details on its composition (human serum matrix, preservatives, stabilizers).
  • Mentioning its stability (36 months at -20°C, 60 days unopened at 2-8°C, 30 days opened at 2-8°C).
  • Product code.

Therefore, I cannot provide the requested information. The document does not contain data related to:

  1. A table of acceptance criteria and reported device performance (for an AI/ML device).
  2. Sample size used for a test set, or its data provenance.
  3. Number/qualifications of experts for ground truth.
  4. Adjudication method for a test set.
  5. MRMC comparative effectiveness study or effect size.
  6. Standalone (algorithm only) performance.
  7. Type of ground truth (expert consensus, pathology, outcomes data).
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

§ 862.1660 Quality control material (assayed and unassayed).

(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.