RANDOX ALDOLASE CALIBRATION SERUM

K142181 · Randox Laboratories Limited · JIT · Sep 18, 2014 · Clinical Chemistry

Device Facts

• Record ID: K142181
• Device Name: RANDOX ALDOLASE CALIBRATION SERUM
• Applicant: Randox Laboratories Limited
• Product Code: JIT · Clinical Chemistry
• Decision Date: Sep 18, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The Aldolase Calibration Serum is intended for in vitro diagnostic use in the calibration of Aldolase on the Randox RX Daytona and Beckman Coulter AU640 systems. This device is for prescription use only.

Device Story

Randox Aldolase Calibration Serum is a lyophilized human serum-based product used to calibrate Aldolase assays on specific clinical chemistry analyzers (Randox RX Daytona and Beckman Coulter AU640). The product is supplied as a kit (3x1ml vials) and requires reconstitution with distilled water. It is intended for professional use in clinical laboratory settings. By providing a standardized reference material with assigned Aldolase values, the device enables the calibration of automated clinical chemistry systems, ensuring accurate measurement of patient Aldolase levels. This supports clinicians in diagnosing and monitoring conditions associated with Aldolase activity. The device is handled by laboratory technicians; it is derived from human serum tested for HIV, HBsAg, and HCV, though it must be treated as potentially infectious.

Clinical Evidence

Bench testing only. Stability studies (open-vial and real-time) confirmed a 5-day reconstituted stability and 2-year shelf life with recovery within ±5% of acceptance criteria. Value assignment was validated via nested testing against master lots on clinical chemistry analyzers, achieving precision (CV) of 1.8% to 2.2%, meeting the ≤3% acceptance criterion.

Technological Characteristics

Lyophilized human serum matrix; contains Aldolase derived from rabbit muscle (Sigma A2714). Designed for use on Randox RX Daytona and Beckman Coulter AU640 systems. Storage at +2°C to +8°C. No electronic or software components.

Indications for Use

Indicated for in vitro diagnostic use as a calibrator for Aldolase assays on Randox RX Daytona and Beckman Coulter AU640 systems. Intended for prescription use.

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) #: k142181

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.