VITROS CHEMISTRY PRODUCTS K+ SLIDES AND CALIBRATOR KIT 2

K073157 · Ortho-Clinical Diagnostics, Inc. · CEM · Dec 7, 2007 · Clinical Chemistry

Device Facts

• Record ID: K073157
• Device Name: VITROS CHEMISTRY PRODUCTS K+ SLIDES AND CALIBRATOR KIT 2
• Applicant: Ortho-Clinical Diagnostics, Inc.
• Product Code: CEM · Clinical Chemistry
• Decision Date: Dec 7, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1600
• Device Class: Class 2

Indications for Use

For in vitro diagnostic use only. VITROS K+ Slides quantitatively measure potassium (K+) concentration in serum, plasma, and urine. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases and conditions characterized by low or high blood potassium levels. For in vitro diagnostic use only. VITROS Calibrator Kit 2 is used to calibrate the VITROS Chemistry Systems for the quantitative measurement of CHOL, CI , ECO2, HDLC, K+, Na+, and TRIG.

Device Story

VITROS Chemistry Products K+ Slides are multilayered analytical elements on polyester support for quantitative measurement of ionic potassium in serum, plasma, and urine. Device uses direct potentiometry via ion-selective electrodes containing valinomycin. Operation involves depositing 10 uL of reference fluid and sample fluid onto separate slide halves; a paper bridge facilitates liquid junction. After 2-minute incubation, VITROS Chemistry System electrometer measures potential difference between reference and indicator electrodes. System microcomputer calculates potassium concentration (mmol/L) using stored calibration parameters. Used in clinical laboratory settings by trained personnel. Output assists clinicians in diagnosing and treating electrolyte imbalances. Modified device utilizes magnetic sputter deposition for ISE baseweb manufacturing compared to electron beam evaporation in predicate.

Clinical Evidence

No clinical data provided; substantial equivalence supported by design control activities, risk analysis, and verification/validation testing.

Technological Characteristics

Ion selective electrode (ISE) component. Material: nickel-chromium alloy (80% Ni, 20% Cr). Manufacturing: magnetic sputter deposition. Compatibility: Vitros 250, 350, 950, and 5,1 FS Series Analyzers.

Indications for Use

Indicated for quantitative measurement of potassium in serum, plasma, and urine to monitor electrolyte balance in patients with conditions characterized by abnormal blood potassium levels.

Regulatory Classification

Identification

A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.

Predicate Devices

• VITROS Chemistry Products K+ Slides (K961115)
• VITROS Chemistry Products Calibrator Kit 2 (K071801)

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 K073157

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.) k961115
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 4 items:

1. The instrumentation for the new device will only support the Vitros 250, 350, 950 and 5,1 FS Series Analyzers.
2. The nickel in the reagents will be replaced with nickel-chromium.
3. The composition of ion selective electrode will change its nickel stripes to include chromium.

The predicate device contained 99% nickel whereas the current device has 80% nickel and 20% chromium.

4. The manufacturing process for the ISE baseweb was previously made with electron beam evaporation and the current device is prepared with magnetic sputter deposition.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and intended use, technology and sample type. The differences are shown above in number 3.
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
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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