LIQUICHEK TUMOR MARKER CONTROL

K071675 · Bio-Rad Laboratories · JJY · Jul 3, 2007 · Clinical Chemistry

Device Facts

• Record ID: K071675
• Device Name: LIQUICHEK TUMOR MARKER CONTROL
• Applicant: Bio-Rad Laboratories
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jul 3, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

Liquichek Tumor Markers Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

Device Story

Liquichek Tumor Markers Control is an assayed quality control material used in clinical laboratories to monitor the precision of testing procedures for various tumor marker analytes. The device is a liquid-form control containing human and animal serum albumin and preservatives. It is provided in three levels (Level 1, 2, and 3) and is stored frozen (-20°C to -70°C). Laboratory technicians use the control to verify the performance of diagnostic assays; results are compared against expected values provided in the package insert to ensure analytical precision. By monitoring these controls, laboratories can identify potential errors in testing procedures, thereby ensuring the reliability of patient test results.

Clinical Evidence

No clinical data. Bench testing only. Stability studies confirmed open-vial stability of 30 days at 2°C to 8°C (15 days for IGF-1) and a two-year shelf life. Value assignments are derived from replicate analysis using FDA-cleared/approved tests.

Technological Characteristics

Ready-to-use liquid control material. Matrix consists of human and animal serum albumin, chemicals, stabilizers, and preservatives (concentration ≤0.1%). Analytes include AFP, B2-M, CA 15-3, CA 19-9, CA 27-29, CA 125, CEA, Ferritin, hCG, IGF-1, PAP, Prolactin, PSA, Free PSA, and Thyroglobulin. Storage at -20°C to -70°C. No specific software or electronic connectivity.

Indications for Use

Indicated for use as an assayed quality control material to monitor the precision of laboratory testing procedures for specific tumor marker analytes in clinical 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 Tumor Markers Control (K011579)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

A. 510(k) Number:
k071675

B. Purpose for Submission:
New Device

C. Measurand:
Alpha-Fetoprotein (AFP), Beta-2-Microglobulin (B2-M), CA 15-3, CA 19-9, CA 27-29, CA 125, Carcinoembryonic antigen (CEA), Ferritin, hCG/Beta hCG (human chorionic gonadotropin), Insulin growth factor-1 (IGF-1), Prostate acid phosphatase (PAP), Prolactin, Prostate specific antigen (PSA), Prostate specific antigen-free (Free PSA), Thyroglobulin.

D. Type of Test:
Quality Control Material

E. Applicant:
Bio-Rad Laboratories

F. Proprietary and Established Names:
Liquichek Tumor Marker Control Levels 1, 2 and 3

G. Regulatory Information:

| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| JJY | Class I | 21 CFR 862.1660
Quality control material (assayed and unassayed) | Chemistry 75 |

H. Intended Use:

1. Intended use(s):
Liquichek Tumor Markers Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

2. Indication(s) for use:
Same as above

3. Special conditions for use statement(s):
Prescription use

4. Special instrument requirements:
Not applicable

I. Device Description:
Liquichek Tumor Markers Control is prepared from human source material with added constituents of human and animal origin, chemicals, stabilizers, and preservatives (cocktail of preservatives in which the concentration of any one ingredient does not exceed 0.1%). The controls are provided in ready-to-use liquid form.

J. Substantial Equivalence Information:
Liquichek Tumor Markers Control claims substantial equivalence to the Lyphocheck Tumor Markers Control (k011579).

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| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | Liquichek Tumor Markers Control is intended as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. | Lyphochek Tumor Markers Control is intended as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. |
| | | |
| Differences | | |
| Item | Device | Predicate |
| Analytes | Alpha-Fetoprotein (AFP), Beta-2-Microglobulin (B2-M), CA 15-3, CA 19-9, CA 27-29, CA 125, Carcinoembryonic antigen (CEA), Ferritin, hCG/Beta hCG (human chorionic gonadotropin), Insulin growth factor-1 (IGF-1), Prostate acid phosphatase (PAP), Prolactin, Prostate specific antigen (PSA), Prostate specific antigen-free (Free PSA), Thyroglobulin | ACTH, Aldosterone, Alpha-Fetoprotein (AFP), Beta-2-Microglobulin (B2-M), CA 15-3, CA 19-9, CA 27-29, CA 50, CA 125, CASA, Calcitonin, Carcinoembryonic antigen (CEA), Ferritin, hCG/Beta hCG (human chorionic gonadotropin), Neuron specific enolase, Prostate acid phosphatase (PAP), Prolactin, Prostate specific antigen (PSA), Prostate specific antigen-free (Free PSA). |
| Levels | Level 1, 2 and 3 | Level 1 and 2 |
| Reagent Preparation | Liquid | Lyophilized |
| Matrix | Human and animal serum albumin | Human serum |
| Preservatives | Contains preservatives | Does not contain preservatives |
| Storage | -20°C to -70°C | 2°C to 8°C; -10°C to -20°C for 30 days after reconstitution |
| Stability, open | IGF-1: 15 days; All other analytes 30 days at 2°C to 8°C. | Ferritin and CA 27-29: 6 days; ACTH, Calcitonin, Free PSA, PSA immediately; all other analytes 14 days at 2°C to 8°C |

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

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):
Traceability: there are no claims for traceability made.
Stability:
Open vial stability: All analytes are stable for 30 days at 2°C to 8°C with the following exception: Insulin-like growth factor (IGF-1) is stable for 15 days.
Shelf life: two-years.
Expected values: Value assignments for each lot are performed by independent manufacturers and laboratories using FDA exempt/cleared/approved tests. Mean values for the three levels are derived from replicate analysis. It is recommended that each laboratory establish its own values and acceptable range. Values and ranges are lot specific.
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:
Not applicable.

N. Proposed Labeling:

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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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