LYPHOCHEK TUMOR MARKET PLUS CONTROL LEVEL 1, 2 AND 3 AND MINIPAK

K082036 · Bio-Rad Laboratories · JJY · Sep 8, 2008 · Clinical Chemistry

Device Facts

• Record ID: K082036
• Device Name: LYPHOCHEK TUMOR MARKET PLUS CONTROL LEVEL 1, 2 AND 3 AND MINIPAK
• Applicant: Bio-Rad Laboratories
• Product Code: JJY · Clinical Chemistry
• Decision Date: Sep 8, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

Lyphochek Tumor Marker Plus 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: Domestic Analytes Listed - Adrenocorticotropic Hormone (ACTH) - Alpha Fetoprotein (AFP) - Aldosterone - Beta-2-Microglobulin (B2M) - CA 15-3 - CA 19-9 - CA 27.29 - CA 125 - Calcitonin - Carcinoembryonic Antigen (CEA) - Ferritin - hCG Beta Subunit (β-hCG)/ hCG - Prostatic Acid Phosphatase (PAP) - Prolactin - Prostate Specific Antigen, Total (PSA) - Prostate Specific Antigen, Free (Free PSA) - Thyroglobulin (Tg) For prescription use only.

Device Story

Lyphochek Tumor Marker Plus Control is a lyophilized, serum-based quality control material used in clinical laboratories to monitor the precision of testing procedures for various tumor markers and hormones. The device is prepared by reconstituting the lyophilized material, which is then analyzed alongside patient samples using standard laboratory instrumentation. Healthcare providers use the resulting control values to verify the accuracy and precision of their diagnostic assays, ensuring the reliability of patient test results. The control is intended for professional use in clinical laboratory environments.

Clinical Evidence

No clinical data. Bench testing only; stability studies performed to validate shelf life and reconstituted stability for various analytes.

Technological Characteristics

Lyophilized serum-based control material. Provided in three levels. Requires reconstitution. Stability: 3 years at 2-8°C (unopened); 14 days at 2-8°C (reconstituted, with specific analyte exceptions); 30 days at -20 to -70°C (reconstituted). No electronic components, software, or energy sources.

Indications for Use

Indicated for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for specific tumor marker analytes in clinical settings. No specific patient population is targeted as the device is a laboratory control material.

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 ASSAY ONLY TEMPLATE

A. 510(k) Number:
k082036

B. Purpose for Submission:
New device

C. Measurand:
Adrenocorticotropic Hormone (ACTH), Alpha Fetoprotein (AFP), Aldosterone, Beta-2-Microglobulin, CA 15-3, CA 19-9, CA 27.29, CA 125, Calcitonin, Carcinoembryonic Antigen (CEA), Ferritin, hCG Beta Subunit (β-hCG)/ hCG, Prostatic Acid Phosphatase (PAP), Prolactin, Prostate Specific Antigen, Total (PSA), Prostate Specific Antigen, Free (Free PSA), Thyroglobulin (Tg)

D. Type of Test:
Quality control material

E. Applicant:
Bio-Rad Laboratories

F. Proprietary and Established Names:
Lyphochek Tumor Marker Plus Control

G. Regulatory Information:
1. Regulation section:
21 CFR §862.1660, Quality Control Material (assayed and unassayed)
2. Classification:
Class I, reserved
3. Product code:
JJY, Multi-analyte controls, all kinds (assayed and unassayed)
4. Panel:
Chemistry (75)

H. Intended Use:
1. Intended use(s):
See Indications for Use below.
2. Indication(s) for use:
Lyphochek Tumor Marker Plus 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:

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Domestic Analytes Listed

- Adrenocorticotropic Hormone (ACTH)
- Alpha Fetoprotein (AFP)
- Aldosterone
- Beta-2-Microglobulin (B2M)
- CA 15-3
- CA 19-9
- CA 27.29
- CA 125
- Calcitonin
- Carcinoembryonic Antigen (CEA)
- Ferritin
- hCG Beta Subunit (β-hCG)/ hCG
- Prostatic Acid Phosphatase (PAP)
- Prolactin
- Prostate Specific Antigen, Total (PSA)
- Prostate Specific Antigen, Free (Free PSA)
- Thyroglobulin (Tg)

3. Special conditions for use statement(s):

For prescription use only.

4. Special instrument requirements:

Values for each lot are listed in the package insert for several analyzers.

I. Device Description:

Lyophilized Lyphochek Tumor Marker Plus Controls (Level 1, 2, and 3) are provided in vials to be reconstituted by the user. They are prepared from human source material with added constituents of human and animal origin, chemicals, stabilizers, and preservatives.

J. Substantial Equivalence Information:

1. Predicate device name(s):

Lyphochek Tumor Marker Control

2. Predicate K number(s):

k011579

3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | Lyphochek Tumor Marker Plus Control is intended as an assayed quality control material to | Lyphochek Tumor Marker Control is intended as an assayed quality control material |

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| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| | monitor the precision of laboratory testing procedures for the analytes listed in the package insert. | to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. |
| Storage (unopened) | 3 years at 2 to 8°C | 3 years at 2 to 8°C |
| Form | Lyophilized | Lyophilized |
| Matrix | Human Serum | Human Serum |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Levels | 3 | 2 |
| Analytes | No claims for: CA 50 CA 72-4 CASA Cyfra 21-1 Neuron Specific Enolase (NSE) | Includes proposed device claims and additional analytes. Does not claim thyroglobulin (Tg) |

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 made for traceability.

Stability:
An accelerated stability study suggested that lyophilized (unreconstituted) vials stored under recommended conditions were stable for 3 years. Real time stability studies demonstrated that lyophilized vials were stable for a minimum of 12 months.

Reconstituted vial stability stored at 2°C to 8°C: All analytes are stable for 14 days with the following exceptions:
Carcinoembryonic Antigen (CEA) is stable for 11 days

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Free and Total PSA is stable for 7 days.

Thyroglobulin (Tg) is stable for 5 days.

ACTH and calcitonin should be assayed immediately.

Reconstituted vials stored at -20°C to -70°C are stable for 30 days with the following exceptions: there are no stability claims at -20°C to -70°C for ACTH and calcitonin.

**Expected values:**

Value assignments for each lot are performed by independent manufacturers and laboratories using FDA-exempt, cleared, or approved tests. Mean values for the three levels are derived from repeated analysis of each analyte. 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:

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.