VALIDATE PSA CALIBRATION VERIFICATION/ LINEARITY TEST KIT MODEL 406

K123127 · Maine Standards Co. · JJX · Jun 14, 2013 · Clinical Chemistry

Device Facts

• Record ID: K123127
• Device Name: VALIDATE PSA CALIBRATION VERIFICATION/ LINEARITY TEST KIT MODEL 406
• Applicant: Maine Standards Co.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Jun 14, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

VALIDATE® PSA Calibration/ Verification/ Linearity Test Kit solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range for the following analytes: Total prostrate-specific antigen (PSA) and free prostrate-specific antigen (fPSA) on automated systems.

Device Story

The VALIDATE PSA Calibration / Linearity Test Kit consists of purified PSA and fPSA chemicals in a human serum base. It is provided in multiple levels to establish the relationship between theoretical and actual performance of automated clinical analyzer systems. The kit is used by laboratory professionals to verify the reportable range and linear response of PSA assays. By comparing the measured values of the test kit levels against expected values, clinicians can ensure the accuracy and reliability of patient PSA testing results, facilitating appropriate clinical decision-making for prostate health monitoring.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

The device consists of purified PSA and fPSA in a human serum base. It is a multi-level, liquid, ready-to-use test kit designed for use on automated clinical chemistry systems. No specific energy source or software algorithm is involved in the test kit itself; it serves as a reference material for system verification.

Indications for Use

Indicated for in vitro diagnostic use to verify linearity, calibration, and reportable range of total PSA and free PSA assays on automated clinical systems.

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 6 Calibration Verification Test Set (k013119)

Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY

A. 510(k) Number:
k123127

B. Purpose for Submission:
New device

C. Measurand:
Multi-analyte control materials

D. Type of Test:
Quantitative, Immunoassay

E. Applicant:
Maine Standards Company LLC

F. Proprietary and Established Names:
VALIDATE® PSA Calibration Verification/ Linearity Test Kit

G. Regulatory Information:

1. Regulation section:
21 CFR § 862.1660 Quality Control Material (assayed and unassayed)

2. Classification:
Class I, reserved

3. Product code:
JJY – Multi-analyte controls, all kinds (assayed)

4. Panel:
Chemistry (75)

H. Intended Use:

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1. Intended use(s):

VALIDATE® PSA Calibration/ Verification/ Linearity Test Kit solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range for the following analytes: Total prostrate-specific antigen (PSA) and free prostrate-specific antigen (fPSA) on automated systems.

2. Indication(s) for use:

Same as Intended use.

3. Special conditions for use statement(s):

For In Vitro Diagnostic Use. For prescription only.

The kit is not intended for use as routine quality control material or as calibration materials.

4. Special instrument requirements:

Automated analyzer systems

I. Device Description:

Each test kit consists of one bottle each of Levels 1 through 6 plus a Base matrix. Each bottle contains 2.5 mL each level, ready to use. There exists a linear relationship among Levels 1 through 6.

Material of human origin used in the manufacture of this test kit has been tested using FDA or CE approved methods and found to be non-reactive for HBV, HCV and HIV.

J. Substantial Equivalence Information:

1. Predicate device name(s):

VALIDATE® Chem 6 Calibration Verification Test Set

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

k013119 (for Uric Acid)

3. Comparison with predicate:

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| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Test kit | Calibration Verification Test Kit | Same |
| Stability | Until expiration date | Same |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | VALIDATE PSA Calibration Verification/Linearity Test Kit for automated systems | VALIDATE Chem 6 Calibration Verification Test Set for Uric Acid in automated, semi-automated and manual instrument systems |
| Analytes | Total PSA and Free PSA | Uric Acid |
| Matrix | Human serum based | Aqueous solution |
| Number of levels | 6 Levels | 5 Levels plus a level zero |
| Packaging | 2.5 mL each level | 5.0 mL each level |
| Storage | -10 to -25°C | 2-8°C |

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

Not applicable

# L. Test Principle:

Not applicable

# M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

Not applicable

b. Linearity/assay reportable range:

A total of six linear dilution levels of Total PSA and Free PSA were tested in triplicate ranging between 0.01 - 148.2 ng/mL for Total PSA and 0.008 - 62.6 ng/mL for Free PSA on representative automated analyzers. Linear regression analysis results are tabulated below. Criteria of acceptability with total allowable error of 0.3 ng/mL or 32% whichever is greater. Linearity claims for these products are: Total PSA: 0.008-150 ng/mL and Free PSA: 0.005-50 ng/mL.

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Linearity was determined using CLSI EP6-A. Results for Total and Free PSA are summarized in the following tables:

| Validate® Total PSA | |
| --- | --- |
| Automated analyzer | Mean vs Target Regression |
| Beckman-Coulter® Access II Immunochemistry Analyzer | y = 0.974x + 0.951 |
| Roche® Cobas 6000 Chemistry Analyzer | y = 1.024x - 0.042 |
| Siemens® Centaur Immunochemistry Analyzer | y = 1.009x - 0.127 |
| Validate® Free PSA | |
| --- | --- |
| Automated analyzer | Mean vs Target Regression |
| Beckman-Coulter® Access II Immunochemistry Analyzer | y = 1.042x - 0.382 |
| Roche® Cobas 6000 Chemistry Analyzer | y = 0.920x + 0.484 |

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

Traceability: Values of this product are linked to the WHO PSA standard based on the respective instrument calibration traceability.

Stability: The sponsor provided protocol, acceptance criteria, and line data with summary.

Real time stability study on the 6 level vials is on-going. Data from 3 lots support 3 months shelf life and 2 lots for 4 months for opened vial.

Open vial freeze-thaw study on 6 levels of Total PSA and Free PSA were performed for 6 freeze-thaw cycles. Data support maximum of 4 freeze/ thaw cycle.

d. Detection limit:

Not applicable

e. Analytical specificity:

Not applicable

f. Assay cut-off:

Not applicable

2. Comparison studies:

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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.

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