OLYMPUS CK-MB REAGENT

• K Number: K971817
• Device Name: OLYMPUS CK-MB REAGENT
• Manufacturer: OLYMPUS AMERICA, INC.
• Date Cleared: 1997-06-11 ( 26 days)
• Product Code: JLB
• Regulation Number: 862.1210
• Type: Traditional
• Panel: CH
• Reference & Predicate Devices: N/A

Intended Use

The Olympus Creatine Kinase MB reagent is for the quantitative determination of Creatine Kinase-MB isoenzyme in human serum on Olympus analyzers.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for the Olympus CK-MB Reagent, not a study report or a detailed technical specification. Therefore, it does not contain the specific information requested in the prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement.

The letter simply states that the FDA has reviewed the 510(k) notification and determined the device is "substantially equivalent" to legally marketed predicate devices for the indicated use, which is the quantitative determination of Creatine Kinase-MB isoenzyme in human serum on Olympus analyzers.

Therefore, I cannot provide the requested information from the given input.

Regulation Number and Section

§ 862.1210 Creatine test system.

(a)
Identification. A creatine test system is a device intended to measure creatine (a substance synthesized in the liver and pancreas and found in biological fluids) in plasma, serum, and urine. Measurements of creatine are used in the diagnosis and treatment of muscle diseases and endocrine disorders including hyperthyroidism.(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 the limitations in § 862.9.