CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3

• K Number: K984277
• Device Name: CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3
• Manufacturer: MEDICAL ANALYSIS SYSTEMS, INC.
• Date Cleared: 1998-12-09 ( 9 days)
• Product Code: JJT
• Regulation Number: 862.1660
• Type: Traditional
• Panel: Clinical Chemistry
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

Cardiolmmune Cardiac Marker Control Levels 1, 2, and 3 is intended for use in the clinical laboratory as an assayed control serum suitable for monitoring various immunoassay and general chemistry assays.

Include Cardiolmmune Cardiac Marker Control Levels 1, 2, and 3 when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter for a medical device called "CardioImmune Cardiac Marker Control Level 1, 2, and 3". It does not contain information about acceptance criteria, study details, performance metrics, sample sizes, expert qualifications, or ground truth establishment.

Instead, the document primarily:

• Confirms that the device is substantially equivalent to legally marketed predicate devices.
• States the intended use of the device.
• Outlines general regulatory information for the manufacturer.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the given text.

Regulation Number and Section

§ 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.