VITROS CHEMISTRY PRODUCTS NA + DT SLIDES, MODEL 153 2290 AND DT CALIBRATOR KIT, MODEL 195 7927
Applicant
Ortho-Clinical Diagnostics, Inc.
Product Code
JGS · Clinical Chemistry
Decision Date
Sep 3, 2009
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 DT Slides quantitatively measure sodium (Na ) concentration in serum and plasma. 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. VITROS Chemistry Products DT Calibrator Kit is specially formulated for use as calibrators for the quantitative measurement of ALB, ALKP, ALT, AMYL, AST, TBIL, NBIL, BUN/UREA, Ca, CHOL, CK, Cl-, Co2, CREA, CRSC, Fe, GGT, GLU, HDLC, K+, LAC, LDH, LIPA, Mg, Na+, NH3, PHOS, TP, TRIG, urCR, and URIC on VITROS DT Chemistry Systems. For in vitro diagnostic use only.
Device Story
VITROS Chemistry Products Na+ Slides; in vitro diagnostic reagent for quantitative sodium measurement in human serum, plasma, and urine. Modification involves transition from multi-packaged to individually packaged slides and expansion of instrument compatibility from high-throughput to low-throughput analyzers. Device operates via automated laboratory analyzer; provides quantitative sodium concentration data to clinicians for diagnostic assessment. Modification verified through method comparison, precision, interference, and stability studies.
Clinical Evidence
Bench testing only. Performance verified through method comparison, precision, interference, and stability studies conducted on automated laboratory analyzers to ensure results are consistent with the predicate device.
Technological Characteristics
In vitro diagnostic reagent slides for sodium measurement. Modification includes individual packaging of slides and compatibility with low-throughput analyzers. Fundamental scientific technology remains consistent with previously cleared VITROS Na+ slide chemistry.
Indications for Use
Indicated for use as an in vitro diagnostic reagent for the quantitative measurement of sodium (Na+) in human serum, plasma, and urine.
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.
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SPECIAL 510(k): Device Modification
ODE Review Memorandum (Decision Making Document is Attached)
To: THE FILE
RE: DOCUMENT NUMBER k091861
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.) k081411 (VITROS Chemistry Products Na+ Slides) and k083680 (VITROS Chemistry Products DT Calibrator Kit).
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:
a. Change in the packaging of the Sodium (Na+) slides, from multi-packaged to individually packaged slides.
b. Change of instrument from a high throughput analyzer to a low throughput analyzer.
4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and sample type. Studies include method comparison, precision, interferences, and stability with automated laboratory analyzer.
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.
