QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945

K073080 · Bio-Rad Laboratories · JJY · Jan 24, 2008 · Clinical Chemistry

Device Facts

• Record ID: K073080
• Device Name: QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945
• Applicant: Bio-Rad Laboratories
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jan 24, 2008
• 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 laboratory testing procedures for the analytes listed in the package insert.

Device Story

Quest Diagnostics Serum Chemistry Control is a multi-analyte quality control material prepared from human serum supplemented with purified biochemical materials, chemicals, preservatives, and stabilizers. Provided in three levels, it serves as a reference to monitor the precision of laboratory testing procedures for a broad panel of general chemistry analytes, including enzymes, lipids, electrolytes, and metabolites. The device is intended for use in clinical laboratories using the Olympus AU5400 instrument. Healthcare providers use the control to verify the performance of their testing systems; results falling within established lot-specific ranges indicate that the laboratory's testing procedures are operating within acceptable precision limits. The product is handled as potentially infectious human-source material.

Clinical Evidence

No clinical data. Evidence consists of bench-top stability studies confirming open-vial stability (30 days at 2-8°C), closed-vial alternate storage (6 months at -10 to -20°C), and shelf life (2 years at -20 to -70°C).

Technological Characteristics

Human serum-based control material; liquid form; contains stabilizers and preservatives. Analyte list includes enzymes, lipids, electrolytes, and proteins. Storage requirements: -20°C to -70°C (shelf), -10°C to -20°C (alternate).

Indications for Use

Indicated for use as a quality control serum to monitor the precision of laboratory testing procedures for specified analytes in clinical laboratory 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.

Predicate Devices

• Quest Diagnostics Serum Chemistry Control (k033387)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE

A. 510(k) Number:
k073080

B. Purpose for Submission:
New Device

C. Measurand:
Quality control materials for general chemistry analytes (see device description below)

D. Type of Test:
N/A

E. Applicant:
Bio-Rad Laboratories

F. Proprietary and Established Names:
Quest Diagnostics Serum Chemistry Control

G. Regulatory Information:
1. Regulation section:
21 CFR § 862.1660 Quality control material (assayed and unassayed)
2. Classification:
Class I
3. Product code:
JJY, Multi-Analyte controls (assayed and unassayed)
4. Panel:
Clinical Chemistry (75)

H. 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 laboratory testing procedures for the analytes listed in the package insert.
2. Indication(s) for use:
See intended use section above.
3. Special conditions for use statement(s):

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For in vitro diagnostic use; for prescription use

4. Special instrument requirements:
Olympus AU5400

I. Device Description:
Quest Diagnostics Serum Chemistry Controls are provided as three levels of control materials. They are prepared from human serum to which purified biochemical materials (tissue extracts of human and animal origin), chemicals, preservatives and stabilizers have been added.

Each serum/plasma donor unit used in the manufacture of this product has been tested by FDA accepted methods and found non-reactive for the presence of HBsAg and antibody to HIV-1/2, HCV and HIV-1 Ag. While these methods are highly accurate, they do not guarantee that all infected units will be detected. Because no known test method can offer complete assurance the hepatitis B virus, hepatitis C virus, human immunodeficiency virus (HIV) or other infectious agents are absent, all products containing human source material should be considered potentially infectious and handled with the same precautions used with patient specimens.

The analyte constituents are as follows:

- Alanine Aminotransferase (ALT/SGPT)
- Albumin
- Alkaline Phosphatase (ALP)
- Amylase
- Aspartate Aminotransferase (AST/SGOT)
- Bilirubin. Direct
- Bilirubin. Total
- Blood Urea Nitrogen
- Calcium
- Chloride
- Cholesterol
- Cholesterol, HDL
- CO2
- Creatine Kinase (CK)
- Creatinine
- Cholesterol, LDL

- Gamma-Glutamyltransferase (GGT)
- Glucose
- Iron
- Iron-Binding Capacity, Unsaturated (UIBC)
- Lactate Dehydrogenase (LDH)

- Lipase
- Magnesium
- Phosphorous
- Potassium
- Sodium
- Thyroxine (T4)
- T3 Uptake
- Total Protein
- Triglycerides
- Uric Acid

J. Substantial Equivalence Information:

1. Predicate device name(s):
Quest Diagnostics Serum Chemistry Control

2. Predicate 510(k) number(s):
k033387

3. Comparison with predicate:

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Quest Diagnostics Serum Chemistry Control claims substantial equivalence to the Quest Diagnostics Serum Chemistry Control currently in commercial distribution. The new Quest Diagnostics Serum Chemistry Control contains the claims for the same analytes as the predicate device, with the addition of new claims for LDL-cholesterol. The predicate claimed ranges for analytes tested on both the Olympus AU5200 and AU5400. This device claims ranges for analytes tested on the Olympus AU5400 only.

K. Standard/Guidance Document Referenced (if applicable):
None were reference.

L. Test Principle:
Not Applicable

M. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
Not Applicable
b. Linearity/assay reportable range:
Not Applicable
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
No traceability was provided.

The ranges were established as follows, limits for mean values (at least 20 replicates) +/- 3SDs of the mean or 25% of allowable total error (ATE). The mean values printed in the package were derived from replicate measurements from various Quest Laboratories using the Olympus AU5400 and are lot specific. The labeling indicates that individual laboratory means should fall within the corresponding acceptable range; however, laboratory means may vary from the listed values during the life of the control material. Variations over time and between laboratories may be caused by differences in laboratory technique, instrumentation and reagents, or by manufacturer test method modifications. The sponsor recommends in the labeling that each laboratory establish its own means and acceptable ranges and use those provided in the labeling only as guides.

Stability studies have been performed to determine the open vial stability and shelf life for the Quest Diagnostics Serum Chemistry Control. Product claims are as follows: open vial: 30 days when stored tightly capped at 2-8°C; alternate Stability (Closed vial): 6 months when stored at -10 to -20°C; and shelf Life: Two years when stored at -20 to -70°C.

Real time studies will be ongoing to support the shelf life of this product. All supporting data is retained on file at Bio-Rad Laboratories.

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d. Detection limit:
Not Applicable

e. Analytical specificity:
Not Applicable

f. Assay cut-off:
Not Applicable

2. Comparison studies:
a. Method comparison with predicate device:
Not Applicable
b. Matrix comparison:
Not Applicable

3. Clinical studies:
a. Clinical Sensitivity:
Not Applicable
b. Clinical specificity:
Not Applicable
c. Other clinical supportive data (when a. and b. are not applicable):
Not Applicable

4. Clinical cut-off:
Not Applicable

5. Expected values/Reference range:
Lot specific ranges are provided for each analyte using the Olympus AU5400 in the labeling.

N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

O. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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