PRECINORM CK-MB AND PRECIPATH CK-MB CONTROLS

K062972 · Roche Diagnostics Corp. · JJX · Oct 13, 2006 · Clinical Chemistry

Device Facts

• Record ID: K062972
• Device Name: PRECINORM CK-MB AND PRECIPATH CK-MB CONTROLS
• Applicant: Roche Diagnostics Corp.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Oct 13, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The intended use of the modified device as described in its labeling has not changed.

Device Story

Precinorm CK-MB and Precipath CK-MB are lyophilized, bovine serum albumin-based quality control materials; contain human-derived CK-MM and porcine-derived CK-BB. Used in clinical chemistry laboratories to monitor accuracy and precision of quantitative CK-MB and creatine kinase assays on Roche analytical systems. Precinorm CK-MB provides control levels in the normal range or at the normal/pathological threshold; Precipath CK-MB provides control levels in the pathological range. Healthcare providers use the output (measured control values compared to assigned setpoints) to verify analytical system performance, detect reagent or instrument variation, and ensure reliable patient test results.

Clinical Evidence

No clinical data. Bench testing only; value assignment performed via internal laboratory testing using independent series and master calibrators to establish setpoints.

Technological Characteristics

Lyophilized control serum; bovine serum albumin base; biological additives (human CK-MM, porcine CK-BB). Reconstituted for use. Stability: 2-8°C shelf life; 24 hours at 25°C or 3 days at 4°C post-reconstitution. Traceability linked to system reagent and calibrator instructions for use.

Indications for Use

Indicated for use as assayed quality control material in Roche test systems to monitor accuracy and precision of quantitative CK-MB and creatine kinase assays; intended for clinical laboratory use to detect systematic analytical deviations.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Predicate Devices

• Precinorm CK-MB (K003158)

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 k062972

This 510(k) submission contains information/data on modifications made to the SUBMITTERS 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 SUBMITTERS previously cleared device. (For a preamendments device, a statement to this effect has been provided.) k003158
2. Submitters 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, users 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 renaming the previously cleared device containing pathological concentrations of CK and CK-MB from Precinorm CK-MB to Precipath CK-MB and adding a new control level containing concentrations of CK and CK-MB at the normal range; the name of this product is Precinorm CK-MB.

4. Comparison Information (similarities and differences) to applicants legally marketed predicate device including, labeling, intended use, physical characteristics, and stability testing.
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. FMEA
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 submitters 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.