PATHFAST CK-MB-II CALIBRATORS

K130628 · Mitsubishi Chemical Medience Corporation · JIT · Oct 4, 2013 · Clinical Chemistry

Device Facts

• Record ID: K130628
• Device Name: PATHFAST CK-MB-II CALIBRATORS
• Applicant: Mitsubishi Chemical Medience Corporation
• Product Code: JIT · Clinical Chemistry
• Decision Date: Oct 4, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The PATHFAST® CK-MB-II Calibrators are for calibration of the PATHFAST® system when used for the quantitative determination of creatine kinase-MB in human heparinized or EDTA whole blood and plasma.

Device Story

PATHFAST CK-MB-II Calibrators are liquid-based reference materials used to calibrate the PATHFAST system for quantitative measurement of creatine kinase-MB (CK-MB) in human heparinized or EDTA whole blood and plasma. The device consists of a liquid Calibrator 1 (saline and preservative) and a lyophilized Calibrator 2 (CK-MB in buffer). The system is used in clinical settings to ensure accurate analyte quantification. The calibrators are loaded into the PATHFAST instrument to establish a calibration curve. By providing a known zero-analyte level (Calibrator 1) and a CK-MB concentration (Calibrator 2), the device enables the instrument to accurately measure patient samples, aiding clinicians in diagnosing or monitoring cardiac conditions associated with CK-MB levels.

Clinical Evidence

Bench testing only. Verification and validation activities performed per design control procedures to assess impact of formulation and packaging changes. Results demonstrated that predetermined acceptance criteria were met.

Technological Characteristics

Liquid calibrator formulation; dropper bottle container; used with PATHFAST Immunoanalyzer; fundamental scientific technology unchanged from predicate.

Indications for Use

Indicated for use as a calibrator for the PATHFAST CK-MB-II assay on the PATHFAST Immunoanalyzer to ensure accurate quantitative measurement of CK-MB in human whole blood or plasma samples.

Regulatory Classification

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.)

Special Controls

*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.

Predicate Devices

• PATHFAST CK-MB-II Calibrator 1 (K081360)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

OIR Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER k130628

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary):

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.) k081360 PATHFAST CK-MB-II Calibrator 1 which is supplied with the PATHFAST CK-MB-II

2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).

3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for:

A. Change from lyophilized to a liquid formulation of Calibrator 1
B. New dropper bottle container
C. Diluent for Calibrator 1 is eliminated

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and analytes.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied
c) A declaration of conformity with design controls. The declaration of conformity should include:

i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and
ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.