ROCHE DIAGNOSTICS CALIBRATOR FOR AUTOMATED SYSTEMS, ROCHE DIAGNOSTICS CALIBRATOR CALIBRATOR FOR AUTOMATED SYSTEM

K101456 · Roche Diagnostics · JIX · Sep 8, 2010 · Clinical Chemistry

Device Facts

• Record ID: K101456
• Device Name: ROCHE DIAGNOSTICS CALIBRATOR FOR AUTOMATED SYSTEMS, ROCHE DIAGNOSTICS CALIBRATOR CALIBRATOR FOR AUTOMATED SYSTEM
• Applicant: Roche Diagnostics
• Product Code: JIX · Clinical Chemistry
• Decision Date: Sep 8, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

1. Calibrator for automated systems (C.f.a.s.) is for use in the calibration for automated Roche methods on Roche chemistry analyzers as specified in the value sheets. 2. C.f.a.s. (Calibrator for automated systems) CK-MB is for use in the calibration of Roche methods for the quantitative determination of CK-MB on Roche clinical chemistry analyzers as specified in the value sheets.

Device Story

Calibrator for automated systems used for clinical chemistry analysis. Modification involves replacing animal-derived enzymes (porcine kidney γ-GT, porcine heart AST, porcine brain CK-BB) with human recombinant equivalents (γ-GT, AST, CK-MB). Includes updates to reference materials (SRM 909b, 956, 929, 914, 967, 1951) and reference method publications (IFCC 2002). Device used in clinical laboratory settings to calibrate automated diagnostic systems. Output provides calibration curves for clinical chemistry assays, enabling accurate patient sample quantification by healthcare providers.

Clinical Evidence

No clinical data. Substantial equivalence supported by design control activities, risk analysis, and verification/validation testing demonstrating that modifications did not alter fundamental scientific technology or performance.

Technological Characteristics

Lyophilized multi-analyte (C.f.a.s.) and single-analyte (C.f.a.s. CK-MB) calibrators. C.f.a.s. base: human serum; C.f.a.s. CK-MB base: bovine serum albumin. Recombinant human proteins used for AST, γGT, and CK-MB. Traceable to SRM 909b, 929, 914, 956, 967, 1951, and IFCC reference methods. Storage: 2-8°C (lyophilized).

Indications for Use

Indicated for use as a calibrator for quantitative Roche clinical chemistry methods on Roche analyzers. C.f.a.s. is a multi-analyte calibrator; C.f.a.s. CK-MB is a single-analyte calibrator for CK-MB determination. No specific patient population or contraindications described.

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

• Roche Diagnostics, Calibrator for automated systems (k062319)
• Roche Diagnostics, Calibrator for automated systems CK-MB (k003158)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

OIVD Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER: k101456

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.)
Roche Diagnostics, Calibrator for automated systems (k062319),
Roche Diagnostics, Calibrator for automated systems CK-MB (k003158)

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. Human recombinant Gamma-glutamyltransferase (γ-GT) replaced porcine kidney γ-GT in Calibrator for automated systems.
B. Human recombinant Aspartate aminotransferase (AST) replaced porcine heart AST in Calibrator for automated systems.
C. For Calibrator for automated systems, there are additional reference materials for five analytes; SRM 909b and SRM 956 for Calcium, SRM 929 and SRM 956 for Magnesium, SRM 914 and SRM 967 for Creatinine Jaffe, SRM 909b (IDMS) and SRM 967 for Creatinine Plus and SRM 909b (IDMS) and SRM 1951 for Triglycerides GB.
D. For Calibrator for automated systems, there are reference material name changes for two analytes; ERM DA470k for Albumin Plus and Primary Reference Material-USP for Salicylate.
E. For Calibrator for automated systems, there are reference method publication updates for four analytes; IFCC (2002), Manual for ALT, IFCC (2002), Manual for AST, IFCC (2002), Manual for CK and IFCC (2002), Manual for LD.
F. Human recombinant Creatine Kinase Isoenzyme MB (CK-MB) replaced porcine brain Creatine Kinase Isoenzyme BB (CK-BB) in Calibrator for automated systems CK-MB.

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

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).

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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.