VITROS CHEMISTRY PRODUCTS CI-DT SLIDES; VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CI-DT SLIDES:131 4905

K082099 · Ortho-Clinical Diagnostics, Inc. · CGZ · Aug 21, 2008 · Clinical Chemistry

Device Facts

• Record ID: K082099
• Device Name: VITROS CHEMISTRY PRODUCTS CI-DT SLIDES; VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CI-DT SLIDES:131 4905
• Applicant: Ortho-Clinical Diagnostics, Inc.
• Product Code: CGZ · Clinical Chemistry
• Decision Date: Aug 21, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1170
• Device Class: Class 2

Indications for Use

For in vitro diagnostic use only. VITROS Cl- DT Slides quantitatively measure chloride (CI-) concentration in serum and plasma. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. VITROS Chemistry Products DT Calibrator Kit For in vitro diagnostic use only. VITROS Chemistry Products DT Calibrator Kit is specially formulated for use as calibrators for ALB, ALKP, ALT, AMY, AST, TBIL, NBIL, BUN/CREA, Ca, CHOL, CK, CI, CO2, CREA, CRSC, Fe, GGT, GLU, HDLC, K , LAC, LDH, LIPA, Mg, Na , NH2, PHOS, TP, TRIG, urCR, and URIC on VITROS DT Chemistry Systems.

Device Story

VITROS Chemistry Products Cl- DT Slides are multilayered analytical elements for direct potentiometric measurement of chloride ions in serum/plasma. Input: 10 uL each of reference fluid and sample fluid deposited on separate halves of the slide. Operation: Reference and indicator electrodes connected by a paper bridge form a stable liquid junction; chloride ions migrate to silver/silver chloride layers to establish equilibrium; potential difference between electrodes is proportional to chloride concentration. Output: Chloride concentration in mmol/L. Used in clinical laboratory settings on VITROS DT Chemistry Systems; operated by laboratory technicians. Results assist healthcare providers in diagnosing/treating metabolic and electrolyte disorders. Benefits: Rapid, quantitative electrolyte assessment.

Clinical Evidence

Bench testing only; design control activities and risk analysis performed to validate manufacturing and formulation changes.

Technological Characteristics

Ion-Selective Electrode (ISE) baseweb; modification to manufacturing process and component formulation. Fundamental scientific technology unchanged.

Indications for Use

Indicated for in vitro diagnostic quantitative measurement of chloride (Cl-) in human serum and plasma to aid in diagnosis and treatment of electrolyte and metabolic disorders, including cystic fibrosis and diabetic acidosis.

Regulatory Classification

Identification

A chloride test system is a device intended to measure the level of chloride in plasma, serum, sweat, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

Predicate Devices

• VITROS Chemistry Products CI DT Slides (K912844)
• VITROS Chemistry Products DT Calibrator Kit (K072443)

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 K082099

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.) k912844, k072443
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 a change in the manufacturing process and formulation of a component of the slide, the Ion-Selective Electrode (ISE) baseweb.

4. Comparison Information (similarities and differences) to applicants 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.