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K Number
K040226
Device Name
WAKO AUTO KIT PREALBUMIN, WAKO AUTOKIT PREALBUMIN CALIBRATOR SET, PREALBUMIN CONTROL SET
Manufacturer
WAKO CHEMICALS, USA, INC.
Date Cleared
2004-03-25

(52 days)

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

The Wako Prealbumin Calibrator Set is intended to be used in the Wako Prealbumin Test System to establish points of reference that are to be used in determination of values in the measurement of prealbumin in human serum or plasma.
The Wako Prealbumin Control Set is intended to be used in the Wako Prealbumin Test System to estimate test precision and detect systematic analytical deviations that may arise from reagent or analytical instrument variation.

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided text, there is no information about the acceptance criteria and the study that proves the device meets those criteria. The document is primarily an FDA 510(k) clearance letter for the "Wako Prealbumin Calibrator Set" and "Wako Prealbumin Control Set", stating that the devices are substantially equivalent to legally marketed predicate devices.

The letter mentions:

  • Trade/Device Name: Wako Prealbumin Calibrator Set, Wako Prealbumin Control Set
  • Regulation Number: 21 CFR 862.1150
  • Regulation Name: Calibrator
  • Regulatory Class: Class II
  • Product Code: JIT, JJX
  • Indications for Use:
    • Wako Prealbumin Calibrator Set: To establish points of reference for determining prealbumin values in human serum or plasma within the Wako Prealbumin Test System.
    • Wako Prealbumin Control Set: To estimate test precision and detect systematic analytical deviations in the Wako Prealbumin Test System.

However, it does not include details on specific performance characteristics, acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement. These details are typically part of the 510(k) submission itself, which is not fully provided here.

§ 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.