Multichem A1c

K162514 · Technopath Manufacturing · JJX · Oct 26, 2016 · Clinical Chemistry

Device Facts

• Record ID: K162514
• Device Name: Multichem A1c
• Applicant: Technopath Manufacturing
• Product Code: JJX · Clinical Chemistry
• Decision Date: Oct 26, 2016
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

Multichem A1c control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analyte, HbA1c as listed in the package insert.

Device Story

Multichem A1c is a liquid quality control material derived from human red blood cells with added chemicals and stabilizers. It is used in clinical laboratories to monitor the precision of HbA1c assay methods. The device is provided in bi-level configurations (Level 1 and Level 2) to cover the clinical range of HbA1c. Laboratory technicians use the control by running it through their existing HbA1c analyzers (e.g., Tosoh, Beckman, Trinity) alongside patient samples. The resulting values are compared against the manufacturer-assigned target ranges to verify instrument performance and ensure the accuracy of patient testing. By identifying potential drift or imprecision in the assay, the device helps clinicians maintain reliable diagnostic results for diabetes management.

Clinical Evidence

Bench testing only. Stability studies (open-vial and closed-vial/shelf-life) were conducted using isochronous protocols and accelerated stress testing (6.5 hours at 37°C) to validate a 12-month shelf life and 30-day open-vial stability. Value assignment was performed across multiple analyzer platforms (Tosoh, Beckman, Trinity) over 5 days with n=15 to 45 replicates per platform. All testing confirmed performance within a drift limit of ≤10%.

Technological Characteristics

Liquid control material composed of human red blood cells, stabilizers, and preservatives. Storage: -20°C to -80°C. Open-vial stability: 30 days at 2°C-8°C. Shelf life: ≥12 months. Analyte: HbA1c. No electronic components or software algorithms.

Indications for Use

Indicated for use as an assayed quality control material to monitor the precision of laboratory testing procedures for HbA1c in clinical settings.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Submission Summary (Full Text)

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

510(k) #: k162514

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.