PATHFAST CTNL CALIBRATORS

K130603 · Mitsubishi Chemical Medience Corporation · JIT · Mar 27, 2014 · Clinical Chemistry

Device Facts

• Record ID: K130603
• Device Name: PATHFAST CTNL CALIBRATORS
• Applicant: Mitsubishi Chemical Medience Corporation
• Product Code: JIT · Clinical Chemistry
• Decision Date: Mar 27, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The PATHFAST® cTnI Calibrators are for calibration of the PATHFAST® system when used for the quantitative determination of cardiac Troponin I in human heparinized or EDTA whole blood and plasma.

Device Story

PATHFAST cTnI Calibrator 1 is an in vitro diagnostic accessory used to calibrate the PATHFAST system for cardiac Troponin I (cTnI) measurement. The device provides a zero-analyte level (0 ng/mL) to establish the calibration curve for the PATHFAST cTnI-II test. The modified version transitions from a lyophilized format to a liquid saline solution containing 0.05% sodium azide, packaged in a polypropylene dropper bottle. The device is used by laboratory personnel in clinical settings. By ensuring accurate calibration of the PATHFAST instrument, the device enables precise quantitative measurement of cTnI, which assists clinicians in the diagnosis of acute myocardial infarction, potentially improving patient management and outcomes.

Clinical Evidence

Bench testing only. Verification and validation activities performed per design control procedures to confirm that the matrix change did not impact device performance or calibration accuracy.

Technological Characteristics

Liquid saline solution with 0.05% sodium azide preservative. Packaged in polypropylene dropper bottle with high-density polyethylene nozzle. Used for zero-point calibration of the PATHFAST system. No changes to fundamental scientific technology or value assignment compared to the lyophilized predicate.

Indications for Use

Indicated for use as a calibration material for the Pathfast cTnl assay on the Pathfast Immunoanalyzer to ensure accurate quantitative measurement of cardiac troponin I in human serum 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 cTnI Calibrator 1 (K100130)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER K130603

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), k100130, Mitsubishi Pathfast cTnl Calibrators. 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.)
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 calibrator matrix change for the zero calibrator from a human serum albumin matrix to buffer matrix.

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: ALARP
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.