VALIDATE CARDIAC MARKER (CM1) CALIBRATION VERIFICATION TEST SET

K053247 · Maine Standards Co. · JJY · Jan 13, 2006 · Clinical Chemistry

Device Facts

• Record ID: K053247
• Device Name: VALIDATE CARDIAC MARKER (CM1) CALIBRATION VERIFICATION TEST SET
• Applicant: Maine Standards Co.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jan 13, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The VALIDATE® Cardiac Marker Calibration Verification Test Sets are used by trained laboratory professionals for quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated, semi-automated and manual chemistry systems for CK-MB and Myoglobin. The VALIDATE® Cardiac Marker Calibration Verification Test Sets are used by trained laboratory professionals. They are not intended for use as routine quality control materials or as calibration materials. They are not intended for use with systems employing reflectance spectroscopy

Device Story

VALIDATE® Cardiac Marker Calibration Verification Test Sets consist of six levels of human serum matrix containing purified CK-MB and myoglobin. Used by laboratory professionals in clinical settings to verify calibration, linearity, and reportable ranges of chemistry analyzers. Not for routine quality control or calibration. Input: test material processed by chemistry analyzer; Output: quantitative recovery values compared against expected ranges to assess system performance. Benefits: ensures accuracy and linearity of cardiac marker testing.

Clinical Evidence

No clinical data. Bench testing only. Stability assessed via real-time and accelerated studies. Value assignment performed via triplicate assays across multiple runs with control material monitoring.

Technological Characteristics

Human serum-based calibration verification material. Liquid, ready-to-use form. 6 levels including zero. Storage at -10 to -20°C. No specific ASTM standards or software algorithms described.

Indications for Use

Indicated for trained laboratory professionals to verify calibration, validate reportable ranges, and determine linearity of automated, semi-automated, and manual chemistry systems for CK-MB and Myoglobin analytes.

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

• Bio-Rad Liquichek Cardiac Markers Control LT (k040277)

Submission Summary (Full Text)

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

A. 510(k) Number:
k053247

B. Purpose for Submission:
New Device

C. Measurand:
CK-MB, Myoglobin

D. Type of Test:
Calibration Verification Material

E. Applicant:
Maine Standards Company

F. Proprietary and Established Names:
Proprietary Name - VALIDATE® Cardiac Marker Calibration Verification Test Sets
Established Name – Quality Control Material

G. Regulatory Information:
1. Regulation section:
21 CFR § 862.1660
2. Classification:
Class I (reserved)
3. Product code:
JJY

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4. Panel:

75 Clinical Chemistry

H. Intended Use:

1. Intended use(s):

See Indications for Use below.

2. Indication(s) for use:

The VALIDATE® Cardiac Marker Calibration Verification Test Sets are used by trained laboratory professionals for quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated, semi-automated and manual chemistry systems for CK-MB and Myoglobin.

3. Special conditions for use statement(s):

The VALIDATE® Cardiac Marker Calibration Verification Test Sets are used by trained laboratory professionals. They are not intended for use as routine quality control materials or as calibration materials. They are not intended for use with systems employing reflectance spectroscopy

4. Special instrument requirements:

Automated, semi-automated and manual chemistry systems.

I. Device Description:

The VALIDATE® Cardiac Marker Calibration (CM1) Verification Test Set contains CK-MB and myoglobin in a human serum matrix. It is comprised of one bottle each of six (6) levels including zero. The sponsor states that for both analytes the contents of Level 0 and Level 1 are identical and should recover the same value. Each bottle contains 3mL and is shipped frozen.

The CM1 Test Set was tested and found negative for HIV-1/2, HCV, HBV, and HBsAg by FDA approved methods.

J. Substantial Equivalence Information:

1. Predicate device name(s):

Bio-Rad Liquichek Cardiac Markers Control LT

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2. Predicate 510(k) number(s):

k040277

3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate (Bio-Rad) |
| Matrix | Same | Human Serum |
| Preparation | Same | Liquid, ready to use |
| Storage | Same | -10 to -20° C |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate (Bio-Rad) |
| Intended Use | For in vitro diagnostic use in quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated, semi-automated, and manual chemistry analyzers. | For use as an assayed quality control serum to monitor the precision of laboratory testing procedures. |
| Number of Levels | 6 including zero | 3 |
| Analytes | CK-MB, Myoglobin | CK-MB, Myoglobin, Digitoxin, Homocysteine, NT-ProBNP, Troponin-I, Troponin-T |
| Stability | Until expiration | 10 days after opening |

# K. Standard/Guidance Document Referenced (if applicable):

CLSI EP-6A: Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline

Guidance for Industry: Points to Consider Guidance Document on Assayed and Unassayed Quality Control Material

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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):
The raw materials (purified human CK-MB and myoglobin) are processed into a stock solution, analyzed, and spiked into the human serum base matrix. The product also includes stabilizers and preservatives. The sponsor states that for value assignment, levels 0, 1, and 5 are assayed in triplicate in three analytical runs while levels 2, 3, and 4 are assayed in triplicate in two analytical runs. Two levels of control material are run with each determination and must fall within the cited acceptance range for the run to be accepted.
Stability is assessed by measuring recoveries in both real-time and accelerated studies.
d. Detection limit:
Not Applicable.
e. Analytical specificity:
Not Applicable
f. Assay cut-off:
Not Applicable.

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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):

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.

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