ALP IFCC Gen.2

K171080 · Roche Diagnostics Operations (Rdo) · CJE · May 10, 2017 · Clinical Chemistry

Device Facts

• Record ID: K171080
• Device Name: ALP IFCC Gen.2
• Applicant: Roche Diagnostics Operations (Rdo)
• Product Code: CJE · Clinical Chemistry
• Decision Date: May 10, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1050
• Device Class: Class 2

Indications for Use

The COBAS Integra ALP IFCC Gen.2 is an in vitro diagnostic test for the quantitative determination of alkaline phosphatase activity in human serum and plasma on COBAS Integra systems.

Device Story

In vitro diagnostic assay; measures alkaline phosphatase (ALP) activity in human serum/plasma; performed on COBAS Integra systems. Modification involves updated traceability from IFCC (1983) to modified IFCC (2011) reference method; addition of I-index (icterus) and L-index (lipemia) interference claims to labeling. Device provides quantitative results to clinicians for diagnostic assessment of liver and bone disorders. Fundamental scientific technology remains unchanged from predicate.

Clinical Evidence

Bench testing only. Verification and validation activities performed based on risk analysis to confirm performance following traceability change and interference claim updates.

Technological Characteristics

In vitro diagnostic reagent assay; photometric measurement principle. Traceability: modified IFCC (2011) reference method. System: COBAS Integra. Software: embedded system control.

Indications for Use

Indicated for quantitative determination of alkaline phosphatase activity in human serum and plasma for clinical diagnostic use.

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 Gen.2 (K033185)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification OIR Decision Summary

To: THE FILE

RE: DOCUMENT NUMBER k171080

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:

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.)

k033185, COBAS Integra ALP IFCC Gen.2

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 the following items:

a) A change in traceability of the ALP2 assay from the IFCC (1983) reference method to the modified IFCC (2011) reference method.

b) The addition of I index and L index for the icterus and lipemia interference claims to the labeling.

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

5. 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.

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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.

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