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K Number
K042406
Device Name
OLYMPUS LACTATE, OSR6193
Manufacturer
OLYMPUS AMERICA, INC.
Date Cleared
2004-12-03

(91 days)

Product Code
JIT
Regulation Number
862.1150
Type
Traditional
Panel
Clinical Chemistry
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Olympus lactate calibrator is a device intended for medical purposes for use in the Olympus lactate test system to establish a standardized point of reference that is used in the determination of lactate values in human plasma and cerebrospinal fluid.

Device Description

Not Found

AI/ML Overview

This 510(k) summary document from the FDA relates to the Olympus Lactate Calibrator, a device used in an in vitro diagnostic setting. The document confirms substantial equivalence to a predicate device but does not contain the detailed study information typically found in a clinical study report for an AI/CADe medical device.

Therefore, I cannot provide most of the requested information, specifically points 1, 2, 3, 4, 5, 6, 7, 8, and 9, as they pertain to the performance evaluation of a device through clinical studies.

Here's what I can extract and explain:

  • Device Name: Olympus Lactate Calibrator
  • Intended Use: To establish a standardized point of reference for determining lactate values in human plasma and cerebrospinal fluid using the Olympus lactate test system.
  • Regulatory Status: Class II (Special Controls), Product Code JIT.

This document is a regulatory clearance letter, not a scientific study report. It indicates that the FDA has reviewed the device and found it substantially equivalent to a legally marketed predicate device, allowing it to be marketed. The detailed performance data and study design (especially for AI/CADe devices) are typically found in the 510(k) submission itself or in separate scientific publications, which are not part of this letter.

In summary, the provided document does not contain the information required to answer your specific questions related to acceptance criteria and device performance studies as it's a regulatory clearance letter for an IVD calibrator, not a clinical study report for an AI/CADe imaging device.

§ 862.1150 Calibrator.

(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special 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.