VALIDATE LIPOPROTEIN CALIBRATION VERIFICATION TEST SET, MODEL 501

K041975 · Maine Standards Co. · JJY · Oct 15, 2004 · Clinical Chemistry

Device Facts

• Record ID: K041975
• Device Name: VALIDATE LIPOPROTEIN CALIBRATION VERIFICATION TEST SET, MODEL 501
• Applicant: Maine Standards Co.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Oct 15, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

VALIDATE Lipoprotein Calibration Test Set is intended for in vitro diagnostic use in quantitatively verifying calibration, validating reportable ranges, and determining linearity on clinical chemistry for the following analytes: cholesterol, HDL-cholesterol, LDLcholesterol, Apolipoprotein A (Apo-A), and Apolipoprotein B (Apo-B).

Device Story

VALIDATE Lipoprotein Calibration Verification Test Set; quality control material for clinical chemistry systems. Input: human serum protein base containing Cholesterol, HDL, LDL, Apolipoprotein A, and Apolipoprotein B. Output: six levels of liquid, ready-to-use samples (including zero) used by laboratory professionals to assess linearity and calibration of automated, semi-automated, or manual chemistry analyzers. Device provides a reference for verifying reportable ranges of specific analytes. Used in clinical laboratory settings; results assist in ensuring accuracy of patient diagnostic testing.

Clinical Evidence

No clinical data. Bench testing only. Performance evaluated using pre-production lots on Roche Hitachi 911 with Roche reagents; compared against College of American Pathologists (CAP) General Chemistry Survey C/CN-3 B 2004.

Technological Characteristics

Human serum-based multi-analyte control; liquid, ready-to-use; 6 levels including zero; 5 mL volume per bottle; stored at -10 to -20°C. Analyte panel: cholesterol, HDL, LDL, Apo-A, Apo-B.

Indications for Use

Indicated for trained laboratory professionals to verify calibration, validate reportable ranges, and determine linearity of clinical chemistry systems for Cholesterol, HDL, LDL, Apolipoprotein A, and Apolipoprotein B.

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

• VALIDATE Chem 4 Calibration Verification Test Set (k012120)

Submission Summary (Full Text)

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

A. 510(k) Number:
k041975

B. Purpose for Submission:
New Device

C. Analyte:
Cholesterol (CHOL), HDL, LDL, Apolipoprotein A, and Apolipoprotein B

D. Type of Test:
Quality Control Materials

E. Applicant:
Maine Standards Co.

F. Proprietary and Established Names:
Validate Lipoprotein (LP) 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 Code:
JJY
4. Panel:
75

H. Intended Use:
1. Intended use(s):
Refer to Indications for use.
2. Indication(s) for use:
The VALIDATE Lipoprotein Calibration Verification Test Set is used by trained laboratory professionals for the quantitative determination of linearity, calibration verification of reportable range in manual, semi-automated and automated clinical chemistry systems for the following analytes: Cholesterol, HDL Cholesterol, LDL Cholesterol, Apolipoprotein A, and Apolipoprotein B

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3. Special condition for use statement(s): For Prescription Use Only
4. Special instrument Requirements: N/A

I. Device Description:
Each VALIDATE Lipoprotein Calibration Verification Test Set contains Cholesterol, HDL Cholesterol, LDL Cholesterol, Apolipoprotein A, and Apolipoprotein B in a human serum protein base. Each test set consists of one bottle each of six (6) levels including zero. Each bottle of Levels 0 through 5 contains 5.0 milliliters.

J. Substantial Equivalence Information:
1. Predicate device name(s): VALIDATE Chem 4 Calibration Verification Test Set
2. Predicate K number(s): k012120
3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | For IN VITRO diagnostic use in quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated semi-automated and manual chemistry systems. | For IN VITRO diagnostic use in quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated semi-automated and manual chemistry systems. |
| Analytes | Cholesterol, HDL Cholesterol, LDL Cholesterol, Apolipoprotein A, and Apolipoprotein B | ALP, ALT, AMY, AST, CK, GGT, LD, LIP, TBIL, DBIL |
| Matrix | Human serum | protein |
| Number of Levels | 6 including zero | 6 including zero |
| Preparation | Liquid, ready to use | Liquid, ready to use |
| Packaging | 5.0 mL each level | 5.0 mL each level |
| Stability | Until Expiration | Until Expiration |
| Storage | -10 to 20^{0} C | -10 to 20^{0} C |

K. Standard/Guidance Document Referenced (if applicable): NCCLS EP6-P

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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 (controls, calibrators, or method):
No traceability provided.
The VALIDATE Lipoprotein Calibration Verification Test set behaves in a manner suitable for the evaluation of calibration and the linear response of the listed analytes over the ranges tested when compared to the College of American Pathologists (CAP) General Chemistry Survey C/CN-3 B 2004.

Equivalence testing was carried out on pre-production lots of VALIDATE Lipoprotein Calibration Verification Test Set using Roche Hitachi 911 with Roche reagents.

Stability is assessed using a real time testing schedule. The labeling recommends that the product be stored at -10 to -20 C.

d. Detection limit:
N/A
e. Analytical specificity:
N/A
f. Assay cut-off:
N/A

2. Comparison studies:
a. Method comparison with predicate device:
N/A
b. Matrix comparison:
N/A

3. Clinical studies:
a. Clinical sensitivity:
N/A

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b. Clinical specificity:
N/A

c. Other clinical supportive data (when a and b are not applicable):
N/A

4. Clinical cut-off:
N/A

5. Expected values/Reference range:
N/A

N. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.