VITROS CHEMISTRY PRODUCT NA+ SLIDES; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2

K081411 · Ortho-Clinical Diagnostics, Inc. · JGS · Jun 30, 2008 · Clinical Chemistry

Device Facts

• Record ID: K081411
• Device Name: VITROS CHEMISTRY PRODUCT NA+ SLIDES; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2
• Applicant: Ortho-Clinical Diagnostics, Inc.
• Product Code: JGS · Clinical Chemistry
• Decision Date: Jun 30, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1665
• Device Class: Class 2

Indications for Use

For in vitro diagnostic use only. VITROS Na Slides quantitatively measure sodium (Na*) concentration in serum, plasma, and urine. Measurements used by this device are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic hormone secretion, or other disease involving electrolyte imbalance. 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 Na+ Slides are multilayered analytical elements on polyester support for quantitative sodium measurement in serum, plasma, and urine. Device uses direct potentiometry via two ion-selective electrodes containing methyl monensin ionophore. Operation involves depositing 10 uL of reference and sample fluids onto slide halves; fluids connect via paper bridge to form liquid junction. After 2-minute incubation, system electrometer measures potential difference between electrodes. Microcomputer uses measurement and stored calibration parameters to calculate sodium concentration (mmol/L). Used in clinical laboratory settings on VITROS Chemistry Systems; operated by laboratory technicians. Output provides quantitative sodium values to clinicians for diagnosing/treating electrolyte imbalances. Modified device utilizes magnetic sputter deposition for ISE baseweb manufacturing, replacing electron beam evaporation.

Clinical Evidence

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

Technological Characteristics

Modified slide component; manufacturing process and formulation changes. Fundamental scientific technology unchanged.

Indications for Use

Indicated for quantitative measurement of sodium in serum, plasma, and urine for diagnosis/treatment of electrolyte-related conditions including aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, and SIADH.

Regulatory Classification

Identification

A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.

Predicate Devices

• k961099
• k073157

Submission Summary (Full Text)

{0}

SPECIAL 510(k): Device Modification

OIVD Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER k081411

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.) k961099; k073157
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 modification was due to a change in the manufacturing process and formulation of a component of the slide.

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

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.