VITROS Chemistry Products Calibrator Kit 3

K161140 · Ortho-Clinical Diagnostics, Inc. · JIX · May 20, 2016 · Clinical Chemistry

Device Facts

• Record ID: K161140
• Device Name: VITROS Chemistry Products Calibrator Kit 3
• Applicant: Ortho-Clinical Diagnostics, Inc.
• Product Code: JIX · Clinical Chemistry
• Decision Date: May 20, 2016
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

For in vitro diagnostic use only. VITROS® Chemistry Products Calibrator Kit 3 is used to calibrate VITROS® 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System for the quantitative measurement of ALT, ALKP, AMYL, AST, CK, GGT, LDH and LIPA.

Device Story

VITROS Chemistry Products Calibrator Kit 3 consists of three levels of lyophilized, multi-analyte calibrators derived from processed bovine serum. It includes calibrator vials and diluent vials. The device is used in clinical laboratory settings to calibrate VITROS Chemistry and Integrated Systems. By providing known concentrations of specific enzymes (ALT, ALKP, AMYL, AST, CK, GGT, LDH, LIPA), the calibrator allows the system to establish a calibration curve for quantitative patient sample analysis. This ensures the accuracy and traceability of clinical chemistry measurements, supporting healthcare providers in diagnosing and monitoring patient conditions related to these analytes.

Clinical Evidence

No clinical data. Bench testing only. Stability studies (shelf-life and open-vial) were conducted per CEN 13640. Traceability was established using reference methods (IFCC, NCCLS) and value transfer protocols.

Technological Characteristics

Lyophilized bovine serum-based multi-analyte calibrator. Three levels. Analyte sources: Porcine (Heart, Kidney, Pancreas) and Chicken Heart. Storage: Frozen ≤ -18°C (24 months); Reconstituted 2-8°C (< 24 hours). Traceability to IFCC/NRSCL reference methods. No software or electronic components.

Indications for Use

Indicated for in vitro diagnostic use to calibrate VITROS Chemistry and Integrated Systems for quantitative measurement of ALT, ALKP, AMYL, AST, CK, GGT, LDH, and LIPA. Prescription use only.

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
## TRIAGE-QUICK REVIEW DECISION SUMMARY

510(k) #: k161140

This 510(k) was reviewed under OIR’s Triage-Quick Review Program. This program represents an internal workload management tool intended to reduce internal FDA review resources for 510(k) applications that are of good quality upon receipt by FDA.

The information in the 510(k) is complete and supports a substantial equivalence (SE) determination. Please refer to the applicant’s 510(k) summary for a summary of the information that supports this SE determination.