QUEST TUMOR MARKER CONTROL, MODEL 955

K042815 · Bio-Rad · JJY · Nov 5, 2004 · Clinical Chemistry

Device Facts

• Record ID: K042815
• Device Name: QUEST TUMOR MARKER CONTROL, MODEL 955
• Applicant: Bio-Rad
• Product Code: JJY · Clinical Chemistry
• Decision Date: Nov 5, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

Quest Diagnostics Tumor Marker 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 Tumor Marker Control is a lyophilized quality control serum derived from human serum with added chemicals and constituents of human/animal origin. It is used in clinical laboratories to monitor the precision of testing procedures for specific tumor marker analytes. The product is reconstituted by laboratory personnel and used to verify the performance of diagnostic assays. By comparing control results against expected values, clinicians assess the reliability of patient test results, ensuring accurate diagnostic monitoring and clinical decision-making. The device provides stability for 14 days at 2-8°C when refrigerated or 30 days at -10 to -20°C when frozen.

Clinical Evidence

No clinical data. Bench testing only. Value assignments were generated by four Quest Diagnostics Laboratories using internal QC material protocols.

Technological Characteristics

Lyophilized human serum matrix with added chemical constituents. No preservatives. Storage at 2-8°C. Reconstituted stability: 14 days at 2-8°C or 30 days at -10 to -20°C. Shelf life: 3 years and 3 months.

Indications for Use

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

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 Marker Control (K011579)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

A. 510(k) Number:
K042815

B. Purpose for Submission:
New device

C. Measurand:
CA 125, CA 19-9, CA 15-3, CA 27.29

D. Type of Test:
Quality control material for automated testing

E. Applicant:
Bio-Rad Laboratories

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

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 all kinds (assayed and unassayed)

4. Panel:
Chemistry 75

H. Intended Use:

1. Intended use(s):
Quest Diagnostics Tumor Marker 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:
Same as the Intended use(s)

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

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4. Special instrument requirements:
Instruments listed in the package insert: Abbott AxSYM (CA 125 and CA 15-3) and the Bayer ADVIA Centaur (CA19-9 and CA 27.29)

I. Device Description:
The Quest Diagnostics Tumor Marker Control is a human serum based product containing constituents of human and animal origin and added chemicals. The controls are provided in lyophilized form at 3 levels.

J. Substantial Equivalence Information:

1. Predicate device name(s):
Bio-Rad Laboratories Lyphochek Tumor Marker Control

2. Predicate 510(k) number(s):
K011579

3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | Intended for use as a quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. | Intended for use as a quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. |
| Matrix | Serum | Same |
| Form | Lyophilized | Same |
| Storage – unopened | 2° - 8°C until expiration date | Same |
| Stability after reconstitution and freezing | All analytes 30 days at -10° to -20°C | Same |
| Preservatives | Does not contain preservatives | Same |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Constituents | CA 15-3, CA 125, CA 19-9, CA 27.29 | CA 15-3, CA 125, CA 19-9, CA 27.29 plus ACTH*, AFP, aldosterone*, β-2 micro-globulin*, CA 50**, CA 72-4**, calcitonin*, |

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| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| | | CASA**, CEA, CYFRA 21-1**, ferritin*, hCG*, hCG – beta subunit*, neuron specific enolase**, PAP, prolactin*, PSA |
| Levels | 3 levels | 2 levels |
| Reconstituted vial claims | All 4 analytes 14 days at 2° - 8°C | CA 27.29 stable for 6 days |

* Not cleared or approved as tumor markers in the US
** Not cleared or approved in the US

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):
The controls are not traceable to any recognized reference material. Value assignments were performed according to Bio-Rad’s QC material protocol. Mean values presented in the package insert were generated by four Quest Diagnostics Laboratories.
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.

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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:
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.