VITROS CHEMISTRY PRODUCTS ECO2 SLIDES

K120765 · Ortho-Clinical Diagnostics, Inc. · KHS · Oct 24, 2012 · Clinical Chemistry

Device Facts

• Record ID: K120765
• Device Name: VITROS CHEMISTRY PRODUCTS ECO2 SLIDES
• Applicant: Ortho-Clinical Diagnostics, Inc.
• Product Code: KHS · Clinical Chemistry
• Decision Date: Oct 24, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1160
• Device Class: Class 2

Indications for Use

The VITROS Chemistry Products ECO₂ Slides are intended for the quantitative measurement of carbon dioxide (CO₂) in serum and plasma.

Device Story

VITROS Chemistry Products ECO₂ Slides; in vitro diagnostic reagent slides for quantitative CO₂ measurement in serum/plasma. Modification involves changing biological source of phosphoenolpyruvate carboxylase (PEPC) from wheat germ to microorganism to improve enzyme stability during manufacturing. Device operates via enzymatic reaction on slide; intended for use in clinical laboratory settings by trained personnel. Output is quantitative CO₂ concentration. Modification does not alter fundamental scientific technology, reagent storage, or stability claims compared to predicate.

Clinical Evidence

No clinical data. Bench testing only. Validation included hazard analysis, accuracy, precision, linearity, potential interferents, long-term and on-analyzer stability, and limit of detection. The modified device met all pre-determined acceptance criteria.

Technological Characteristics

Multi-layered analytical element on polyester support. Enzymatic detection principle using Phosphoenolpyruvate carboxylase (microorganism-derived), Malate dehydrogenase, phosphoenolpyruvate, and NADH. Reflectance spectrophotometry measurement. Designed for use on VITROS 250/350/950/5,1 FS, 4600, and 5600 systems. No software algorithm described; device relies on system-level reflectance measurement.

Indications for Use

Indicated for quantitative measurement of carbon dioxide (CO₂) in serum and plasma for clinical diagnostic purposes.

Regulatory Classification

Identification

A bicarbonate/carbon dioxide test system is a device intended to measure bicarbonate/carbon dioxide in plasma, serum, and whole blood. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.

Predicate Devices

• VITROS Chemistry Products ECO₂ Slides (k001133)

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: k120765

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) for the VITROS Chemistry Products ECO₂ Slides:

1. The name and 510(k) number of SUBMITTER'S previously cleared device: Ortho Clinical Diagnostics, VITROS Chemistry Products ECO₂ Slides (k001133).

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 VITROS ECO₂ Slides:

1) Change in biological source of phosphoenolpyruvate carboxylase (PEPC), one of the reactive ingredients used in the slides, from wheat germ to microorganism. The Sponsor claims that this change provides improved stability of the enzyme solution during manufacturing. However, the reagent storage and stability claims of the modified slides remain unchanged from the predicate device.

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