FASTPACK TOTAL PSA METHOD VERIFICATION KIT

K062957 · Qualigen, Inc. · JJX · Apr 2, 2007 · Clinical Chemistry

Device Facts

• Record ID: K062957
• Device Name: FASTPACK TOTAL PSA METHOD VERIFICATION KIT
• Applicant: Qualigen, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Apr 2, 2007
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The FastPack® Total PSA Method Verification Kit consists of assayed quality control materials for verification of the calibration and reportable range of the FastPack® Total PSA Immunoassay to meet CLIA requirements.

Device Story

Qualigen FastPack Total PSA Method Verification Kit provides assayed quality control materials for verifying calibration and reportable range of FastPack Total PSA Immunoassay. Kit contains three liquid, ready-to-use verifiers at 0, 25, and 50 ng/mL concentrations. Verifiers consist of human PSA purified from seminal fluid in TRIS buffer with bovine serum albumin and 0.1% sodium azide preservative. Used with FastPack analyzer by laboratory personnel to ensure assay performance meets CLIA requirements. Value assignment involves running verifiers across multiple analyzers and lots, calculating mean concentrations, and ensuring results fall within specified acceptable limits. Device provides standardized reference points to confirm accuracy of PSA measurements in clinical settings.

Clinical Evidence

No clinical data. Bench testing only. Performance established via value assignment protocols using multiple analyzers and lots to calculate robust means and ensure results fall within specified concentration ranges. Stability supported by accelerated studies at 25°C, 30°C, and 37°C, with real-time testing ongoing.

Technological Characteristics

Liquid, ready-to-use assayed quality control material. Composition: Human PSA (purified from seminal fluid), TRIS buffer, bovine serum albumin, 0.1% sodium azide. Three levels: 0, 25, 50 ng/mL. Used with FastPack analyzer. Storage: 4°C.

Indications for Use

Indicated for use as assayed quality control materials to verify calibration and reportable range of the FastPack® Total PSA Immunoassay in clinical laboratory settings to meet CLIA requirements.

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

• FastPack® PSA Controls (k003095)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

A. 510(k) Number:
k062957

B. Purpose for Submission:
New device

C. Measurand:
Controls for total PSA (tPSA)

D. Type of Test:
Assayed Quality Control material

E. Applicant:
Qualigen Incorporated

F. Proprietary and Established Names:
Qualigen™ FastPack® Total PSA Method Verification 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:
JJX, Single (specified) analyte controls (assayed and unassayed)
4. Panel:
Chemistry (75)

H. Intended Use:
1. Intended use(s):
The FastPack® Total PSA Method Verification Kit consists of assayed quality control materials for verification of the calibration and reportable range of the FastPack® Total PSA Immunoassay to meet CLIA requirements.
2. Indication(s) for use:
Same as intended use.
3. Special conditions for use statement(s):
For prescription use only.
4. Special instrument requirements:
FastPack® analyzer

I. Device Description:
The FastPack® Total PSA Method Verification Kit consists of three assayed controls materials targeted at three PSA concentrations: Low Verifier (0 ng/mL), Mid Verifier (25 ng/mL) and high Verifier (50 ng/mL). The verifiers contain a specified quantity of human PSA (purified from human seminal fluid) in TRIS buffer supplemented with bovine serum albumin (BSA) and preservative (0.1% sodium azide).

J. Substantial Equivalence Information:
1. Predicate device name(s):
FastPack® PSA Controls
2. Predicate 510(k) number(s):
k003095

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3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended use | Assayed quality control materials for verification of the calibration and reportable range of the FastPack® Total PSA Immunoassay to meet CLIA requirements | Assayed quality control materials for verification of the accuracy and precision of the FastPack® Analyzer system when used for the quantitative determination of PSA in human serum or plasma |
| Analytes | Total PSA | Same |
| Antigen source | Human seminal fluid | Same |
| Matrix | BSA in TRIS buffer | Same |
| Format | Liquid, ready-to-use | Same |
| Volume | 5 mL | Same |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Levels | Three levels (0, 25 and 50 ng/mL) | Two levels (2 and 10 ng/mL) |

K. Standard/Guidance Document Referenced (if applicable):
Guidance for Industry “Points to consider guidance document on assayed and unassayed quality control material”.

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 company provided a general document which outlines the protocols, materials, calculations and specifications for assigning values to controls and calibrators for FastPack assay. The following is a brief stepwise description of the value assignment process:
- Calibrate instruments with master calibrator lot and run released controls
- Run on-test Calibrator B as a sample and record raw RLU values
- Run on-test Calibrator A and controls as samples and record the recovered value.
- Runs should be evenly distributed among analyzers and test the

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following samples:

| Sample | #lots | Min # Analyzers | Min # runs/lots |
| --- | --- | --- | --- |
| Calibrator A | 1 | 1 | 3 |
| Calibrator B | Min of 2 (3 if available) | 3 | 20 |
| Low control | 1 | 3 | 20 |
| High control | 1 | 3 | 20 |
| Low verifier | 3 | 3 | 20 |
| Mid verifier | 3 | 3 | 20 |
| High verifier | 3 | 3 | 20 |

- Use Excel to calculate the mean value of the samples by lot and analyzer. Results will be in concentration units except for Cal B which will be in normalized RLU/second
- Specifications – All released values must be within specified acceptable range and all mean values must be within specified acceptable limits

| Assay | Cal A ng/mL | Cal B | Low control ng/mL | High Control ng/mL | Low Verifier Ng/mL | Mid Verifier ng/mL | High Verifier ng/mL |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Total PSA | ≤0.04 | N/A | 1-3 | 5-15 | 0-0.04 | 22-28 | 50-80 |

- Controls are run during master curve verification of sublot-2 prior to final value assignment. Compare those control values to the value assignment. If trends are noted, notify supervisor.
- For PSA, there should be no more than a $10\% \mathrm{CV}$ of the data used to generate the robust mean. If the $\mathrm{CV} > 10\%$ , compare the observed values to the assigned range. If all observed values fall within the range, proceed with the value assignment. If any observed value falls outside the range, determine if it is an outlier. If it is an outlier, remove the value and recalculate the results. If it is not determined to be an outlier, notify supervisor and document action taken by retesting sample and inspect pack.
- There should be no more than a $10\%$ difference between the mean values (in concentration units) from each lot
- If all pass, proceed to value assignment; if any value fails, generate a non-conformance report and notify supervisor.
- Value assignment for method verifiers – use Excel to calculate the mean value (in concentration units) and the SD of the verifiers by combining all data.

The company claimed that the device is stable for 12 months when stored at $4^{\circ}\mathrm{C}$ . Shelf life determination was based on accelerated stability study at $25^{\circ}\mathrm{C}$ for 32 days, $30^{\circ}\mathrm{C}$ for 18 days and $37^{\circ}\mathrm{C}$ for 8 days. Real-time stability testing for closed and opened vials are ongoing.

d. Detection limit:

Not applicable

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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.