A1C-CELLULAR

K040025 · Streck Laboratories, Inc. · JJX · Mar 2, 2004 · Clinical Chemistry

Device Facts

• Record ID: K040025
• Device Name: A1C-CELLULAR
• Applicant: Streck Laboratories, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Mar 2, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

A1c-Chex is a bi-level whole blood based, assayed control for monitoring performance of analysis procedures for HbA1c.

Device Story

A1c-Chex is a bi-level, whole blood-based, assayed quality control material used to monitor the performance of HbA1c analysis procedures. It is designed to be treated as a patient specimen and processed according to the instructions of the specific instrument, kit, or reagent being used. By mimicking a patient specimen, it allows laboratory personnel to verify the accuracy and reproducibility of the analytical process, including the lysing of red blood cells. The device is used in clinical laboratory environments to ensure the reliability of glycated hemoglobin measurements, which are critical for diabetes management.

Clinical Evidence

No clinical data. Bench testing only. Traceability established by assaying each lot using up to eight reagents across three methodologies (immunoassays, Ionic Exchange HPLC, Boronate affinity). Expected ranges derived from the mean of all values ± 1% (normal) or ± 2% (abnormal).

Technological Characteristics

Bi-level, whole blood-based assayed control. Formulated from human whole blood adjusted to specific concentrations of glycated hemoglobin. Open vial stability of 30 days. No electronic, software, or energy-based components.

Indications for Use

Indicated for monitoring the performance of HbA1c analysis procedures in clinical laboratory settings. Intended for use as a whole blood control material to monitor the complete analytical process, including lysing of red blood cells.

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.

Predicate Devices

• Medical Analysis Systems, Inc. Diabetes Control (k023307)

Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
DEVICE TEMPLATE

A. 510(k) Number: k040025
B. Analyte: HbA1c
C. Type of Test: N/A
D. Applicant: Streck Laboratories
E. Proprietary and Established Names: A1c-Chex

F. Regulatory Information:
1. Regulation section: 21 CFR 862.1660
2. Classification: Class I
3. Product Code: JJX
4. Panel: 75

G. Intended Use
1. Intended use(s): See indications for use.
2. Indication(s) for use:
A1c-Chex is a bi-level whole blood based, assayed control for monitoring performance of analysis for HbA1c.
3. Special condition for use statement(s): None
4. Special instrument Requirements: Beckman Synchron/CX7, Dade Dimension, Bio-Rad Varian/II, Tosoh G7/A1c, Roche Integra

H. Device Description:
A1c-Chex consists of Control materials for verifying performance of analysis procedures for HbA1c. The controls contain human red blood cells and preservative suspension medial packaged in a 15 x 30 mm clear glass vial.

I. Substantial Equivalence Information:
1. Predicate device name(s): Medical Analysis Systems, Inc. Diabetes Control

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2. Predicate K number(s): k023307

3. Comparison with predicate:

| DEVICE | PREDICATE |
| --- | --- |
| | |
| The controls contain human red blood cells and preservative suspension media. This control can be used to monitor RBC lysis. | MAS Diabetes Control is a lyophilized product prepared from human whole blood adjusted to specific concentrations of glycolated hemoglobin. MAS Diabetes control does not monitor the RBC lysis in the hemoglobin A1c analytic methods. |
| A1c-Chex has an open vial stability of 30 days. | MAS Diabetes Control has an open vial stability of 14 days. |

J. Standard/Guidance Document Referenced (if applicable) None Referenced

K. Test Principle: N/A

L. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility: N/A
b. Linearity/assay reportable range: N/A
c. Traceability (controls, calibrators, or method):

Each lot is assayed by up to eight different reagents with at least three different methodologies (immunoassays, Ionic Exchange HPLC, Boronate affinity). The abnormal level expected range is derived from the mean of all the values ± 2%. The normal level expected range is derived from the mean of all the values ± 1%.

d. Detection limit (functional sensitivity): N/A
e. Analytical specificity: N/A
f. Assay cut-off: N/A

2. Comparison studies:

a. Method comparison with predicate device: NA
b. Matrix comparison: NA

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3. Clinical studies:
a. Clinical sensitivity: N/A
b. Clinical specificity: N/A

4. Clinical cut-off: N/A

5. Expected values/Reference range: N/A

M. Conclusion: Based upon the information provided, I recommend that the Streck Laboratories A1c-Chex control system be found substantially equivalent with the predicate device as defined in 21 CFR 862.1660.