LIQUICHEK TORCH PLUS IGM CONTROL

K040822 · Bio-Rad Laboratories, Inc. · JJY · May 19, 2004 · Clinical Chemistry

Device Facts

• Record ID: K040822
• Device Name: LIQUICHEK TORCH PLUS IGM CONTROL
• Applicant: Bio-Rad Laboratories, Inc.
• Product Code: JJY · Clinical Chemistry
• Decision Date: May 19, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

Liquichek™ ToRCH Plus IgM Control is intended for use as an unassayed quality control serum to monitor precision of IgM laboratory testing procedures for the analytes listed in this package insert. This product is not intended for use in blood donor screening assays. Analytes listed: Toxoplasma gondii IgM, Rubella Virus IgM, Cytomegalovirus (CMV) IgM, Herpes Simplex Virus Type 1/2 (HSV-1/2) IgM, Epstein-Barr Virus (EBV) Viral Capsid Antigen (VCA) IgM, and Lyme (Borrelia burgdorferi) IgM.

Device Story

Liquichek™ ToRCH Plus IgM Control serves as unassayed quality control material for laboratory IgM testing. Kit includes positive and negative controls; processed identically to patient specimens. Matrix consists of negative human sera spiked with mouse IgM monoclonal antibodies conjugated to human IgM. Used in clinical laboratories to monitor precision of IgM assays for Toxoplasma gondii, Rubella, CMV, HSV-1/2, EBV VCA, and Lyme disease. Does not provide diagnostic results; assists in verifying assay performance stability.

Clinical Evidence

No clinical data. Evidence consists of bench testing, specifically stability studies confirming 60-day open-vial stability at 2-8°C and 3-year shelf life at -20°C or colder.

Technological Characteristics

Liquid, serum-based control material. Contains negative human sera and mouse IgM monoclonal antibodies conjugated to human IgM. Unassayed. Designed for use with analyte-specific EIA testing procedures.

Indications for Use

Indicated for use as an unassayed quality control serum to monitor precision of IgM laboratory testing procedures for Toxoplasma gondii, Rubella, CMV, HSV-1/2, EBV VCA, and Lyme (Borrelia burgdorferi) IgM. Not for blood donor screening. Prescription use only.

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

• VIROTROL ToRCH (k942295)

Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY

A. 510(k) Number:
k040822

B. Analyte:
ToRCH Plus panel IgM antibodies

C. Type of Test:
Precision controls

D. Applicant:
Bio-Rad Laboratories

E. Proprietary and Established Names:
Liquichek™ ToRCH Plus IgM Control

F. 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, all kinds (assayed and unassayed)
4. Panel:
Chemistry (75)

G. Intended Use:
1. Intended use(s):
Liquichek™ ToRCH Plus IgM Control is intended for use as an unassayed quality control serum to monitor precision of IgM laboratory testing procedures for the analytes listed in this package insert. This product is not intended for use in blood donor screening assays. Analytes listed: Toxoplasma gondii IgM, Rubella Virus IgM, Cytomegalovirus (CMV) IgM, Herpes Simplex Virus Type 1/2 (HSV-1/2) IgM, Epstein-Barr Virus (EBV) Viral Capsid Antigen (VCA) IgM, and Lyme (Borrelia burgdorferi) IgM.
2. Indication(s) for use:
Liquichek™ ToRCH Plus IgM Control is intended for use as an unassayed quality control serum to monitor precision of IgM laboratory testing procedures for the analytes listed in this package insert. This product is not intended for use in blood donor screening assays. Analytes listed: Toxoplasma gondii IgM, Rubella Virus IgM, Cytomegalovirus (CMV) IgM, Herpes Simplex Virus Type 1/2 (HSV-1/2) IgM, Epstein-Barr Virus (EBV) Viral Capsid Antigen (VCA) IgM, and Lyme (Borrelia burgdorferi) IgM.
3. Special condition for use statement(s):
Prescription use
4. Special instrument Requirements:
Not applicable

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H. Device Description:

These are unassayed IgM controls for the ToRCH panel (Toxoplasma, Rubella, CMV, and Herpes 1/2,) plus EBV VCA and Lyme (Borrelia burgdorferi) group of assays. Both positive and negative controls are part of the kit. The control materials are made of negative human sera and monoclonal antibodies as analytes. The controls are to be processed the same way as patient specimens.

I. Substantial Equivalence Information:

1. Predicate device name(s): VIROTROL ToRCH
2. Predicate K number(s): k942295
3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Procedure | Unassayed controls, positive and negative | Unassayed controls, positive and negative |
| Matrix | Serum based | Serum based |
| Form | Liquid | Liquid |
| Differences | | |
| Item | Device | Predicate |
| Analytes tested | IgM antibodies to: CMV,EBV VCA,HSV-1/2, Lyme (B. burgdorferi), and Toxoplasma gondii | IgM & IgG antibodies to: CMV,EBV VCA,and HSV-1/2 |
| Analyte composition | Mouse IgM monoclonals conjugated to human IgM | Native IgM human antibodies |

J. Standard/Guidance Document Referenced (if applicable): Not applicable

K. Test Principle: Analyte specific EIA

L. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility: Not applicable
b. Linearity/assay reportable range: Not applicable

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c. Traceability (controls, calibrators, or method):
Not applicable

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

M. Conclusion:
The descriptive characteristics reported here for the device indicates that it is comparable to other such test kits currently in the market.