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K Number
K972408
Device Name
CARDIAC STATUS CONTROLS
Manufacturer
SPECTRAL DIAGNOSTICS, INC.
Date Cleared
1997-07-25

(29 days)

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

Cardiac STATus™ Controls are intended for use as assayed quality control materials in quality assurance programs to monitor the performance of the Spectral Diagnostics Inc. Cardiac STATus™ CKMB/Myoglobin Rapid Test. These external controls complement the monitoring of the test performance by the internal control provided in each test device.

Device Description

Cardiac STATus™ Controls /CK-MB/Myoglobin

AI/ML Overview

I am unable to extract specific acceptance criteria and study details from the provided text to fulfill your request. The document is a 1997 FDA 510(k) clearance letter for "Cardiac STATus™ Controls," which are quality control materials for an in-vitro diagnostic test, not a medical device that performs a diagnosis or algorithm.

The text primarily details:

  • The FDA's decision of substantial equivalence for the Cardiac STATus™ Controls.
  • Regulatory classifications and requirements for the device.
  • Instructions for the manufacturer regarding labeling, promotion, and other regulatory obligations.
  • The intended use of the Cardiac STATus™ Controls as "assayed quality control materials in quality assurance programs to monitor the performance of the Spectral Diagnostics Inc. Cardiac STATus™ CKMB/Myoglobin Rapid Test."

There is no mention of a study involving algorithmic performance, human readers, or detailed acceptance criteria for a diagnostic device's accuracy. Thus, I cannot construct the table or answer the specific questions about sample sizes, ground truth, experts, or comparative effectiveness studies that you've asked for.

§ 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.