LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A - E FOR BECKMAN COULTER SYNCHRON SYSTEMS

K031921 · Cliniqa Corporation · JJY · Aug 25, 2003 · Clinical Chemistry

Device Facts

• Record ID: K031921
• Device Name: LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A - E FOR BECKMAN COULTER SYNCHRON SYSTEMS
• Applicant: Cliniqa Corporation
• Product Code: JJY · Clinical Chemistry
• Decision Date: Aug 25, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The LiniCAL Chemistry Calibration Verifiers, Levels A-E for Beckman Coulter Synchron Systems is intended for use as an assayed quality control material for analysis.

Device Story

LiniCAL™ Chemistry Calibration Verifiers are assayed quality control materials used to verify the calibration and linearity of clinical chemistry assays on Beckman Coulter Synchron® Systems. The device consists of five levels (A-E) of liquid-stable, human-serum based materials. It is used by laboratory professionals in clinical settings to monitor instrument performance and ensure the accuracy of patient test results. By comparing measured values of the verifiers against expected values, clinicians can confirm that the analytical measurement range of the instrument is properly calibrated.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Liquid-stable, human-serum based quality control material. Provided in five levels (A-E). Designed for use with Beckman Coulter Synchron® chemistry analyzers. No specific materials or software algorithms described.

Indications for Use

Indicated for use as an assayed quality control material for clinical laboratory analysis to verify calibration and assess linearity of Beckman Coulter Synchron Systems.

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)

{0}

510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
DEVICE ONLY TEMPLATE

A. 510(k) Number:
K031921

B. Analyte:
Chemistry calibration verifiers for Beckman Coulter Synchron Systems containing the following constituents: albumin, BUN, calcium, creatinine, lactate, magnesium, phosphorus, total protein, triglycerides, glucose, iron, sodium, potassium, chloride.

C. Type of Test:
N/A

D. Applicant:
Cliniqa Corporation

E. Proprietary and Established Names:
LiniCAL Chemistry Calibration Verifiers, Levels A-E for Beckman Coulter Synchron Systems.

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

G. Intended Use:
1. Indication(s) for use:
The LiniCAL Chemistry Calibration Verifiers, Levels A-E for Beckman Coulter Synchron Systems is intended for use as an assayed quality control material for analysis.
2. Special condition for use statement(s):
N/A
3. Special instrument Requirements:
N/A

{1}

Page 2 of 3

H. Device Description:

The LiniCAL Chemistry Calibration Verifiers are human serum-based, containing constituents of human origin. They are used in the clinical laboratory to verify calibration and/or assess linearity of the Beckman Coulter Synchronm Systems. Five assayed levels of albumin, BUN, calcium, creatinine, lactate, magnesium, phosphorus, total protein, triglycerides, glucose, iron, sodium, potassium, and chloride are provided to allow monitoring of the reportable range.

I. Substantial Equivalence Information:

1. Predicate device name(s):
LiniCAL Protein @ Calibration Verifiers Levels A-E for Beckman Coulter
Immage System.

2. Predicate K number(s):
K013332

3. Comparison with predicate:
Both devices are human serum-based products that are manufactured using the same processes. They differ in that the constituents in the predicate device are alpha-1-acid-glycoprotein, alpha-1-antitrypsin, alpha-2-macroglobulin, antithrombin III, beat-2-macroglobulin, and ceruloplasmin, and the constituents in the subject device are of albumin, BUN, calcium, creatinine, lactate, magnesium, phosphorus, total protein, triglycerides, glucose, iron, sodium, potassium, and chloride

J. Standard/Guidance Document Referenced (if applicable):
N/A

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

{2}

Page 3 of 3

2. Comparison studies:
a. Method comparison with predicate device: N/A
b. Matrix comparison: N/A

3. Clinical studies:
a. Clinical sensitivity: N/A
b. Clinical specificity: N/A
c. Other clinical supportive data (when a and b are not applicable): 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 Cliniqa LiniCAL Chemistry Verifiers, Levels A-E for Beckman Coulter Synchron Systems be found substantially equivalent to predicate devices according to 21 CFR 862.1660.