LIQUICHEK SPECIALTY IMMUNOASSAY CONTROL

K043108 · Bio-Rad Laboratories, Inc. · JJY · Dec 7, 2004 · Clinical Chemistry

Device Facts

• Record ID: K043108
• Device Name: LIQUICHEK SPECIALTY IMMUNOASSAY CONTROL
• Applicant: Bio-Rad Laboratories, Inc.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Dec 7, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

Liquichek™ Specialty Immunoassay Control is intended for use as a quality control serum to monitor the precision of laboratory testing procedures listed in the package insert

Device Story

Liquichek™ Specialty Immunoassay Control is a multi-analyte quality control serum used in clinical laboratories to monitor the precision of immunoassay testing procedures. The device consists of human serum supplemented with chemicals, stabilizers, and preservatives (5-chloro-2-methyl-2H-isothiazol-3-1). It is provided in three levels as a ready-to-use liquid. Laboratory personnel use the control to verify the performance of assays for Anti-TG, Anti-TPO, C-peptide, EPO, iPTH, IGF-1, Osteocalcin, and 25-OH Vitamin D. By comparing observed results against assigned mean values and ranges provided in the package insert, clinicians can assess the stability and accuracy of their testing systems. The device serves as an external quality control measure to ensure reliable diagnostic results for patients.

Clinical Evidence

No clinical data. Bench testing only. Stability studies were conducted to validate open vial stability (30 days at 2-8°C, with 21-day exceptions for Anti-Tg and Anti-TPO) and shelf-life stability (2 years at -20°C to -70°C) using accelerated and real-time testing protocols.

Technological Characteristics

Matrix: Human serum with added human/animal constituents, chemicals, stabilizers, and preservatives. Form: Liquid. Storage: -20 to -70°C. Analyte list: Anti-Tg, Anti-TPO, C-peptide, EPO, iPTH, IGF-I, Osteocalcin, 25-OH Vitamin D.

Indications for Use

Indicated for use as a quality control serum to monitor the precision of laboratory testing procedures for specific analytes (Anti-Tg, Anti-TPO, C-peptide, EPO, iPTH, IGF-I, Osteocalcin, 25-OH Vitamin D) 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

• Lypochek Immunoassay Plus Control (k981532)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

A. 510(k) Number:
k043108

B. Purpose for Submission:
This is a new device.

C. Measurand:
Quality Control material for the following:
- Anti-TG
- Anti-TPO
- C-peptide
- Erythropoietin (EPO)
- Intact PTH (iPTH)
- IGF-1
- Osteocalcin
- 25-OH Vitamin D

D. Type of Test:
Not applicable

E. Applicant:
Bio-Rad Laboratories

F. Proprietary and Established Names:
Liquichek™ Specialty Immunoassay Control

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

H. Intended Use:
1. Intended use(s):
Liquichek™ Specialty Immunoassay Control is intended for use as a quality control serum to monitor the precision of laboratory testing procedures listed in the package insert

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

3. Special conditions for use statement(s):
For prescription use only

4. Special instrument requirements:
Not Applicable

I. Device Description:
This product is prepared from human serum with added constituents, chemicals, stabilizers, and preservatives. Three levels of control are available and are provided ready to use.

Substantial Equivalence Information:
1. Predicate device name(s):
Lypochek Immunoassay Plus Control
2. Predicate 510(k) number(s):
k981532
3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| | Liquichek™ Specialty Immunoassay Control | Lypochek Immunoassay Plus Control |
| Intended Use | For use as quality control serum to monitor the precision of laboratory testing procedures listed in the package insert. | Same |
| Matrix | Human serum | Same |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Form | Liquid | Lyophilized |
| Preservatives | Contains Preservatives (5-chloro-2-methyl-2H-isothiazol-3-1 | None |
| Analytes | Contains only the following analytes:
1. Anti-TG
2. Anti-TPO
3. C-peptide
4. Erythropoietin (EPO) | Contains the following analytes:
1. 25-OH Vitamin D
2. C-peptide
3. Intact PTH
Does not contain:
1. Anti-TG |

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| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| | 5. Intact PTH (iPTH)
6. Insulin like Growth Factor (IGF-1)
7. Osteocalcin
8. 25-OH Vitamin D | 2. Anti-TPO
3. Erythropoietin (EPO)
4. Insulin like Growth Factor (IGF-1)
5. Osteocalcin |

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

L. Test Principle:
Not applicable. This submission is for clearance of control material.

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 mean values printed in the insert were derived from replicate analyses and are specific for a particular lot. The material is analyzed by the reagent manufacturer and/or independent laboratories using manufacturer supported reagents. For value assignment, a minimum of 20 replicates per level per analyte over a period of 10 days are run. Means established by individual laboratory should fall within the corresponding acceptable range. Refer to the package insert for the assigned values and ranges. It is recommended that each laboratory establish its own means and acceptable ranges and use those provided only as guides.

Stability studies were performed as follows:
- Open Vial: At least six time points (time 0 and five additional time points at regular interval during the study period) per temperature, per analyte, per level are assayed using three vials in singlicate. The study time is defined to be at least 20% longer than the claimed open vial stability
- Shelf Life:
1. Accelerated Stability: At least six time points (time 0 and five additional time points at regular interval during the study period) per temperature, per analyte, per level are assayed using three

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vials in singlicate. The study time is defined to be at least 20% longer than the claimed shelf life stability.

2. Real Time Stability: At least eight time points (i.e. time 0, 6, 9, 12, 24, 27, 36 and 40 months) per analyte, per level are assayed using at least four vials to obtain a total of eight replicates. The study time is defined to be at least 20% longer than the claimed shelf life stability.

The results are as follows:
Open vial stability is 30 days at 2°C to 8°C with the following exceptions:
Anti-Tg and Anti-TPO will be stable for 21 days.
Shelf Life Stability is 2 years at -20°C to -70°C.

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

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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 based upon a Tier I review.

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