LIGAND PLUS CONTROL LEVEL 1-3

K033344 · Consolidated Technology · JJY · Jan 16, 2004 · Clinical Chemistry

Device Facts

• Record ID: K033344
• Device Name: LIGAND PLUS CONTROL LEVEL 1-3
• Applicant: Consolidated Technology
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jan 16, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

Ligand Plus Control is a lyophilized, human serum based assayed quality control material intended to monitor the performance of clinical immunochemistry and therapeutic drug test procedures.

Device Story

Ligand Plus Control is a lyophilized, human serum-based quality control material containing 55 analytes (purified human/animal components, drugs, non-organic components). Used in clinical laboratories to monitor performance of immunochemistry and therapeutic drug test procedures. Supplied in 5.0 mL vials at three levels. Healthcare providers use the control to verify assay accuracy and precision by comparing results against target values derived from interlaboratory data. Benefits include ensuring reliability of clinical immunoassay test results.

Clinical Evidence

No clinical data. Bench testing only; substantial equivalence is demonstrated through comparison of intended use, physical properties, and performance characteristics to the predicate device.

Technological Characteristics

Lyophilized human serum-based matrix; contains <0.1% sodium azide; three-level configuration; stored at 2 °C to 8 °C; 55 analytes of clinical significance; packaged in 7 mL amber glass vials.

Indications for Use

Indicated for use as a quality control material to monitor the performance of clinical immunoassay test procedures for immunochemistries and therapeutic drugs. Intended for professional laboratory use.

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

• Immunoassay Plus Control (K020237)

Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
DEVICE ONLY TEMPLATE

A. 510(k) Number:
K033344

B. Analyte:
Quality control material (assayed and unassayed)

C. Type of Test:
Quantitative

D. Applicant:
Consolidated Technologies, Inc.

E. Proprietary and Established Names:
Ligand Plus Control

F. Regulatory Information:
1. Regulation section:
21 CFR 862.1660
2. Classification:
Quality control material (assayed and unassayed)
3. Product Code:
JJY
4. Panel:
75

G. Intended Use:
1. Intended use(s):
Ligand Plus Control is a lyophilized, human serum based assayed quality control material intended to monitor the performance of clinical immunochemistry and therapeutic drug test procedures.
2. Indication(s) for use:
Ligand Plus Control, Levels 1, 2 and 3, is a lyophilized human serum based assayed quality control material intended to monitor the performance of clinical immunoassay test procedures that analyze immunochemistries and therapeutic drugs as listed in this package insert.
3. Special condition for use statement(s):
Not applicable
4. Special instrument Requirements:
See the assay sheet provided

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H. Device Description:
The device contains purified human and animal components, purified drugs and non-organic components added to a human serum based matrix, for a total of 55 analytes. The control is supplied lyophilized in five- 5.0 mL vials at three levels.

I. Substantial Equivalence Information:
1. Predicate device name(s):
Immunoassay Plus Control
2. Predicate K number(s):
K020237
3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | Assayed or unassayed quality control for monitoring performance of routine chemistry test procedures | Assayed or unassayed quality control for monitoring performance of routine chemistry test procedures |
| Matrix | Processed human serum | Processed human serum |
| Form | Lyophilized | Lyophilized |
| Levels | 3 Levels | 3 Levels |
| Differences | | |
| Item | Device | Predicate |
| Analytes of clinical significance | 55 analytes | 59 analytes |

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

K. Test Principle:
Not applicable

L. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
Not applicable
b. Linearity/assay reportable range:
Not applicable
c. Traceability (controls, calibrators, or method):
Purified human and animal components

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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:
The assay values and expected ranges are target values derived from interlaboratory data. The expected range values include variations of instrument, reagent and laboratory handling. The assay values were obtained using in-date reagents available at the time of testing. Overall group mean and standard deviation per constituent per method was calculated.

M. Conclusion:
The Ligand Plus Control is similar to the predicate device in intended use, matrix, form, constituents, and stability. In addition, the manufacturing, stability, and value assignment information provided for the control were adequate. I recommend a substantial equivalence determination for the Ligand Plus Control.