QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945

K033387 · Bio-Rad · JJY · Dec 2, 2003 · Clinical Chemistry

Device Facts

• Record ID: K033387
• Device Name: QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945
• Applicant: Bio-Rad
• Product Code: JJY · Clinical Chemistry
• Decision Date: Dec 2, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

Quest Diagnostics Serum Chemistry Control is intended for use as a quality control serum to monitor the precision of an individual laboratory’s automated and manual testing procedures.

Device Story

Quest Diagnostics Serum Chemistry Control is a liquid, human serum-based quality control material. It contains purified biochemical materials, chemicals, preservatives, and stabilizers. The device is used in clinical laboratories to monitor the precision of automated and manual testing procedures for various serum chemistry analytes. Healthcare providers use the control results to verify the performance and accuracy of their diagnostic testing systems, ensuring reliable patient results. The product is stored frozen (-10°C to -20°C) and has a 10-day open-vial stability when refrigerated at 2-8°C.

Clinical Evidence

Bench testing only. Stability studies were performed to establish shelf life (two years at -10 to -20°C) and open-vial stability (10 days at 2-8°C). No clinical data was required or provided.

Technological Characteristics

Liquid, human serum-based control material. Contains purified biochemical materials, chemicals, preservatives, and stabilizers. Storage: -10°C to -20°C (unopened); 2-8°C (open vial).

Indications for Use

Indicated for use as a quality control serum to monitor the precision of automated and manual laboratory testing procedures for multiple analytes.

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

• Bio-Rad Laboratories Liquid Assayed Multiqual Control (k011867)

Submission Summary (Full Text)

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

A. 510(k) Number: k033387
B. Analyte: Quality Control material for multiple analytes
C. Type of Test: N/A
D. Applicant: Bio-Rad Laboratories
E. Proprietary and Established Names: Quest Diagnostics Serum Chemistry Control

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

G. Intended Use:
1. Intended use(s): Quest Diagnostics Serum Chemistry Control is intended for use as a quality control serum to monitor the precision of an individual laboratory’s automated and manual testing procedures.
2. Indication(s) for use: Quest Diagnostics Serum Chemistry Control is for use as a quality control serum to monitor the precision of an individual laboratory’s automated and manual-testing procedures.
3. Special condition for use statement(s): none stated
4. Special instrument Requirements: Olympus AU5200; AU5400

H. Device Description: Quest Diagnostics Serum Chemistry Control is prepared from human serum to which purified biochemical materials (tissue extracts of human serum and animal origin), chemicals, preservatives, and stabilizers have been added.

I. Substantial Equivalence Information:
1. Predicate device name(s): Bio-Rad Laboratories Liquid Assayed Multiqual Control

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2. Predicate K number(s): k011867

3. Comparison with predicate:

| Similarities & Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Characteristics | Quest Diagnostics Serum Chemistry Control | Bio-Rad Liquid Assayed Muliqual Control |
| Intended Use | Quest Diagnostics Serum Chemistry Control is intended for use in clinical laboratories as a portion of Quality Assurance to aid in the maintenance of accuracy and precision in the clinical chemistry laboratory. | Liquid Assayed Muliqual Control is intended for use in clinical laboratories as an assayed quality control serum to monitor the precision of laboratory procedures listed in the package insert. |
| Form | Liquid | Liquid |
| Matrix | Human serum based plasma | Human serum based plasma |
| Other ingredients | Stabilizers and preservatives | Stabilizers and preservatives |
| Storage | -10°C to -20°C Until expiration date | -20°C r colder Until expiration date |
| Open Vial claim | 10 days at 2-8°C | 14 days at 2-8°C |
| Storage | No Claim | 30 days at 2-8°C |
| Analytes | ALT, Albumin, Alkaline Phosphatase, Amylase, AST, Direct Bilirubin, Total Bilirubin, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, HDL-C, CO2, Creatine Kinase, Gamma - Glutamyltransferase, Glucose, Iron, Lactate Dehydrogenase, Lipase, Magnesium, Phosphorus, | The predicate device contains other specific analytes not included in the new product. |

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| | Potassium, Sodium, T3 Uptake, T4, Total Protein, Triglycerides, Iron-Binding capacity, Unsaturated Iron Binding Capacity, Uric Acid. | |
| --- | --- | --- |

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

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): None Referenced
d. Detection limit: N/A
e. Analytical specificity: N/A
f. Assay cut-off: N/A

2. Comparison studies:
a. Method comparison with predicate device: N/A
b. Matrix comparison: Quest Diagnostics Serum Chemistry Control is prepared from human serum to which purified biochemical materials (tissue extracts of human serum and animal origin), chemicals, preservatives, and stabilizers have been added.

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

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M. Conclusion: Based upon the information provided, I recommend that the Quest Diagnostics Serum Chemistry Control for multiple analytes be found substantially equivalent to the predicate device.