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K Number
K992981
Device Name
ELECSYS ESTRADIOL CALSET II
Manufacturer
ROCHE DIAGNOSTICS CORP.
Date Cleared
1999-09-24

(21 days)

Product Code
JIT
Regulation Number
862.1150
Type
Traditional
Panel
CH
Reference & Predicate Devices
K965109
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

For the calibration of the quantitative estradiol assay on the Elecsys 1010 and 2010 immunoassay systems.

Device Description

Roche Diagnostics Elecsys® Estradiol CalSet II consists of lyophilized human serum with added estradiol in two concentration ranges.

AI/ML Overview

The provided text describes a 510(k) summary for the "Elecsys® Estradiol CalSet II" but does not contain information about acceptance criteria or a study proving that the device meets such criteria.

The document focuses on:

  • Introduction to the device: Elecsys® Estradiol CalSet II, an in vitro diagnostic calibrator.
  • Intended Use: For the calibration of the quantitative estradiol assay on the Elecsys® 1010 and 2010 immunoassay systems.
  • Substantial Equivalence: A comparison to a predicate device (Elecsys® Estradiol CalSet) outlining similarities (intended use, two levels) and differences (format, matrix, stability).
  • FDA Clearance: The letter from the FDA granting clearance based on substantial equivalence.

Therefore, I cannot provide the requested information about acceptance criteria and the study that proves the device meets the acceptance criteria from the given text.

The document is a regulatory submission for device clearance, not a performance study report with acceptance criteria.

§ 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.