← Product Code [CGN](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGN) · K043318

# MODIFICATION TO ROCHE ELECSYS FOLATE II IMMUNOASSAY (K043318)

_Roche Diagnostics Corp. · CGN · Dec 23, 2004 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGN/K043318

## Device Facts

- **Applicant:** Roche Diagnostics Corp.
- **Product Code:** [CGN](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGN.md)
- **Decision Date:** Dec 23, 2004
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 862.1295
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Indications for Use

Binding assay for the in vitro quantitative determination of folate in human serum. The binding assay is intended for use on the Roche Elecsys 2010 and MODULAR ANALYTICS E170 (Elecsys module) immunoassay analyzers.

## Device Story

Modified Class II/III/I device; modifications include increased sample volume, reagent formulation change, value assignment process change, and onboard stability reduction from 6 weeks to 1 week. Device utilizes existing fundamental scientific technology. Design control activities, including risk analysis and verification/validation, performed to ensure performance criteria met. Intended use remains unchanged from previously cleared device.

## Clinical Evidence

No clinical data provided; substantial equivalence established through bench testing and comparison of analytical performance characteristics.

## Technological Characteristics

In vitro diagnostic device; modifications include reagent formulation, sample volume, and value assignment process. Onboard stability adjusted to 1 week. Fundamental scientific technology remains unchanged.

## Regulatory Identification

A folic acid test system is a device intended to measure the vitamin folic acid in plasma and serum. Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia, which is characterized by the presence of megaloblasts (an abnormal red blood cell series) in the bone marrow.

## Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification
OIVD Review Memorandum

To: THE FILE
RE: DOCUMENT NUMBER K 043318

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.

The change was for 1) an increase in sample volume 2) a change in reagent formulation 3) a change in value assignment process 4) change in onboard stability from 6 weeks to 1 week

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.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGN/K043318](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGN/K043318)

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