VALIDATE SP1 CALIBRATION VERIFICATION/LINEARITY TEST SET, MODEL 601

K072246 · Maine Standards Co. · JJY · Sep 14, 2007 · Clinical Chemistry

Device Facts

• Record ID: K072246
• Device Name: VALIDATE SP1 CALIBRATION VERIFICATION/LINEARITY TEST SET, MODEL 601
• Applicant: Maine Standards Co.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Sep 14, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

VALIDATE® SP1 Calibration Verification Test Set solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range in automated, semi-automated and manual chemistry systems for the following analytes: Immunoglobulin A (IgA), Immunoglobulin G, IgG), Immunoglobulin M (IgM), Complement C3 (C3), Complement C4 (C4), α1-Antitrypsin (AAT), and Transferrin (TRF).

Device Story

VALIDATE® SP1 Calibration Verification Test Set consists of human serum-based solutions containing multiple levels of specific analytes (IgA, IgG, IgM, C3, C4, AAT, Transferrin). The device is used in clinical laboratory settings to verify the linearity and reportable range of chemistry analyzers. It is not intended for routine quality control or calibration. The test set includes five levels of material with a known linear relationship. By running these samples, clinicians compare the analyzer's measured output against the expected linear performance to ensure the system is operating within specifications. This verification process helps maintain the accuracy of patient diagnostic results.

Clinical Evidence

Bench testing only. Stability studies performed with acceptance criteria of >90% recovery. Shelf life established at one year for storage at -10°C to -20°C.

Technological Characteristics

Human serum-based calibration verification material; five-level test set; 1.0 mL per bottle; liquid form; intended for use in automated, semi-automated, and manual chemistry systems.

Indications for Use

Indicated for use in clinical laboratories to verify calibration, assess linearity, and verify the reportable range of automated, semi-automated, or manual chemistry systems for IgA, IgG, IgM, C3, C4, AAT, and Transferrin. 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

• Cliniqa LiniCAL® Calibration Verifier Protein 1 (k031575)
• Cliniqa LiniCAL® Calibration Verifier Protein 2 (k031577)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

A. 510(k) Number:
k072246

B. Purpose for Submission:
New device

C. Measurand:
Quality controls for IgA, IgG, IgM; C3, C4, α1-Antitrypsin and Transferin

D. Type of Test:
Quantitative determination in automated, semi-automated, manual chemistry systems

E. Applicant:
Maine Standards Company

F. Proprietary and Established Names:
VALIDATE® SP1 Calibration Verification Test Set

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

H. Intended Use:
1. Intended use(s):
VALIDATE® SP1 Calibration Verification Test Set solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range in automated, semi-automated and manual chemistry systems for the following analytes: Immunoglobulin A (IgA), Immunoglobulin G, IgG), Immunoglobulin M (IgM), Complement C3 (C3), Complement C4 (C4), α1-Antitrypsin (AAT), and Transferrin (TRF).
2. Indication(s) for use:
Same as Intended use.
3. Special conditions for use statement(s):
For prescription only.
4. Special instrument requirements:
None

I. Device Description:
VALIDATE® SP1 Calibration Verification Test Sets are human serum materials containing 5 levels of each of the seven analytes. Each test set consists of one bottle (1.0 mL) each of Level 1 to Level 5.

J. Substantial Equivalence Information:
1. Predicate device name(s):
Cliniqa LiniCAL® Calibration Verifier Protein 1

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Cliniqa LiniCAL® Calibration Verifier Protein 2

2. Predicate K number(s):
k031575 (IgA, IgG, IgM, C3, C4, TRF)
k031577 (AAT)

3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| | VALIDATE® SP1 Calibration Verification Test Set | Cliniqa LiniCAL® Calibration Verifier Protein 1 and Protein 2 |
| Intended Use | For in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range in automated, semi-automated and manual chemistry systems | For in vitro diagnostic use in the clinical laboratory to verify calibration and/ or assess linearity. Five assayed levels are provided to allow monitoring of the reportable range |
| Matrix | Human serum | Same |
| Number of Levels | 5 Levels | Same |
| Packaging | 1.0 mL each level | Same |
| Format | Liquid | Same |
| Differences | | | |
| --- | --- | --- | --- |
| Item | New Device | Predicate Devices | |
| | VALIDATE® SP1 Calibration Verification Test Set | Cliniqa LiniCAL® Calibration Verifier Protein 1 | Cliniqa LiniCAL® Calibration Verifier Protein 2 |
| Analytes | IgA, IgG, IgM, C3, C4, AAT, and TRF | IgA, IgG, IgM, C3, C4, and TRF | AAT, AAG, AMG, AT3, B2M, CER |
| Stability | One year | Opened vial: 14 days | Opened vial: 14 days |
| Storage | -10°C to -20°C | 2 - 8°C | 2 - 8°C |

K. Standard/Guidance Document Referenced (if applicable):
CLSI EP6: Evaluation of linearity

L. Test Principle:
Not applicable

M. Performance Characteristics (if/when applicable):
1. Analytical performance:

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a. Precision/Reproducibility:
Not applicable.

b. Linearity/assay reportable range:
Not applicable.

c. Traceability, Stability, Expected values (controls, calibrators, or methods):
Stability studies were performed with the acceptance criteria of >90% recovery from date of manufacture. Stability data showed shelf life of 2.5 years for -10°C and 5 years for -20°C. The expiration date claim is one year for -10 to -20°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.

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.