LYPHOCHEK ASSAYED CHEMISTRY CONTROL

K040273 · Bio-Rad Laboratories, Inc. · JJY · Mar 4, 2004 · Clinical Chemistry

Device Facts

• Record ID: K040273
• Device Name: LYPHOCHEK ASSAYED CHEMISTRY CONTROL
• Applicant: Bio-Rad Laboratories, Inc.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Mar 4, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

Lyphochek Assayed Chemistry Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

Device Story

Lyphochek Assayed Chemistry Control is a human serum-based quality control product used in clinical laboratories to monitor the precision of testing procedures. It contains purified biochemicals, tissue extracts, chemicals, therapeutic drugs, preservatives, and stabilizers. The product is provided in lyophilized form at two levels. Laboratory personnel use the control to verify the performance of analytical assays. By comparing observed results against the lot-specific mean values provided in the package insert, clinicians and laboratory technicians assess the stability and accuracy of their testing systems, ensuring reliable diagnostic results for patients.

Clinical Evidence

No clinical data. Stability studies were performed to validate shelf life (3 years + 4 months at 2-8°C) and open-vial stability (7 days at 2-8°C, with 3-day exception for Acid Phosphatase/Prostatic Acid Phosphatase; 30 days at -10 to -20°C, with 20-day exception for Tobramycin).

Technological Characteristics

Lyophilized human serum matrix containing purified biochemicals, chemicals, therapeutic drugs, preservatives, and stabilizers. Storage at 2-8°C. Analyte-specific assay values provided for laboratory monitoring.

Indications for Use

Indicated for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for specific analytes in clinical chemistry 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

• Lyphochek Assayed Chemistry Control (k874280)

Submission Summary (Full Text)

{0}

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

A. 510(k) Number:
k040273

B. Analyte:
Quality control material (assayed & unassayed)

C. Type of Test:
Quantitative

D. Applicant:
Bio-Rad Laboratories, Inc.

E. Proprietary and Established Names:
Lyphochek® Assayed 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):
Lyphochek Assayed Chemistry Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
2. Indication(s) for use:
Lyphochek Assayed Chemistry Control is for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
3. Special condition for use statement(s):
Prescription use
4. Special instrument Requirements:
See instruments listed in the package insert.

{1}

Page 2 of 4

H. Device Description:
Lyphochek Assayed Chemistry Control is a human serum based product containing constituents of purified biochemicals (tissue extracts of human and animal origin), chemicals, therapeutic drugs, preservatives, and stabilizers. The control is provided in lyophilized form at two levels, each consisting of twelve (12) 5-mL vials.

I. Substantial Equivalence Information:
1. Predicate device name(s):
Lyphochek Assayed Chemistry Control
2. Predicate K number(s):
k874280
3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | Monitor precision of laboratory testing procedures for various analytes | Monitor precision of laboratory testing procedures for various analytes |
| Matrix | Serum | Serum |
| Form | Lyophilized | Lyophilized |
| Levels | Two | Two |
| Differences | | |
| Item | Device | Predicate |
| Constituents | Same as the predicate device (72 analytes) with the following exceptions: | |
| | Does not contain claims for aldolase and folate | Contains claims for aldolase and folate |
| | Contains claims for the following analytes: calcium (ionized), copper, glutamate dehydrogenase (GLDH), globulin, cholesterol (LDL), iron-binding capacity, total (TIBC), iron-binding capacity, unsaturated (UIBC), T3 free, T4 free, transferrin, vitamin B12, and zinc | Does not contain claims for the following analytes listed to the left |

{2}

Page 3 of 4

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

K. Test Principle:
Not applicable

L. Performance Characteristics (if/when applicable):

1. Analytical performance:
a. Precision/Reproducibility:
Not applicable
b. Linearity/assay reportable range:
Not applicable
c. Traceability (controls, calibrators, or method):
None referenced
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:
The mean values printed in the insert were derived from replicate analyses and are lot specific. The tests listed were performed by the reagent manufacturer and/or independent laboratories using manufacturer supported reagents and a representative sampling of this lot of control.

M. Conclusion:
The Lyphochek Assayed Chemistry Control is similar to the predicate device with the exception of sixteen (16) constituents. However, the difference in these constituents does not raise new issues of safety and effectiveness. Additionally, the value

{3}

Page 4 of 4

assignment and stability information provided for the calibrator were adequate. Therefore, a substantial equivalence determination is recommended for the Lyphochek Assayed Chemistry Control.