COBAS INTEGRA ALP IFCC GEN.2

K033185 · Roche Diagnostics Corp. · CJE · Oct 14, 2003 · Clinical Chemistry

Device Facts

• Record ID: K033185
• Device Name: COBAS INTEGRA ALP IFCC GEN.2
• Applicant: Roche Diagnostics Corp.
• Product Code: CJE · Clinical Chemistry
• Decision Date: Oct 14, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1050
• Device Class: Class 2

Intended Use

The cassettes COBAS Integra ALP IFCC Gen.2 Small (ALP2S) and COBAS Integra ALP IFCC Gen.2 Large (ALP2L) contains an in vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of the catalytic activity of alkaline phosphatase in human serum and plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.

Device Story

In vitro diagnostic reagent system for COBAS Integra clinical chemistry analyzers; utilizes colorimetric assay method per IFCC recommendations. Input: human serum or plasma samples. Principle: magnesium and zinc ions facilitate cleavage of p-nitrophenyl phosphate by alkaline phosphatase into phosphate and p-nitro-phenol; p-nitro-phenol concentration is directly proportional to catalytic ALP activity. Output: quantitative measurement of ALP activity (U/L). Used in clinical laboratory settings by trained technicians. Results assist physicians in diagnosing and monitoring liver, bone, parathyroid, and intestinal disorders.

Clinical Evidence

Bench testing only. Verification and validation activities performed per design control requirements; results met predetermined acceptance criteria confirming substantial equivalence.

Technological Characteristics

In vitro diagnostic reagent; dual-reagent (R2) format; citrate buffer system. Photometric assay principle. Designed for use on COBAS Integra automated clinical chemistry analyzers.

Indications for Use

Indicated for the quantitative determination of alkaline phosphatase (ALP) activity in human serum and plasma on COBAS Integra systems.

Regulatory Classification

Identification

An alkaline phosphatase or isoenzymes test system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.

Predicate Devices

• COBAS Integra ALP IFCC Assay (K981897)

Submission Summary (Full Text)

{0}

SPECIAL 510(k): Device Modification

ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER K033185

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.)
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.
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 changing from a succinate buffer to a citrate buffer, changing from a mono reagent (R1) to a dual reagent (R2) and changing the name of the assay to COBAS Integra ALP IFCC Gen2.

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).

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.