IMMULITE 2000 FREE PSA CALIBRATION VERIFICATION MATERIAL

K133816 · Siemens Healthcare Diagnostics, Inc. · JJX · Jun 24, 2014 · Clinical Chemistry

Device Facts

• Record ID: K133816
• Device Name: IMMULITE 2000 FREE PSA CALIBRATION VERIFICATION MATERIAL
• Applicant: Siemens Healthcare Diagnostics, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Jun 24, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The IMMULITE® Free PSA Calibration Verification Material (CVM) is intended for monitoring system performance of the IMMULITE Immunoassay system for the quantitative measurement of Free PSA antigen.

Device Story

The IMMULITE 2000 Free PSA Calibration Verification Material (CVM) is a quality control product used to monitor the performance of the IMMULITE Immunoassay system. It consists of four vials containing varying levels of Free PSA antigen in a bovine protein/buffer matrix. The device is supplied in lyophilized form and is intended for single use. Laboratory personnel use the CVM to verify the accuracy and stability of the immunoassay system's quantitative measurements of Free PSA. By comparing recovered values against assigned target concentrations, clinicians can ensure the system is operating within established performance specifications, thereby supporting reliable diagnostic testing for patients.

Clinical Evidence

No clinical data. Bench testing only. Value assignment performed using 18 replicates across two kit lots and four instruments. Stability validated over 42 months (one lot) and 6 months (two lots) with >90% recovery.

Technological Characteristics

Lyophilized bovine protein/buffer matrix with preservatives. Four-level (zero, low, intermediate, high) calibration verification material. Traceable to WHO NIBSC 1st International Standard 96/668. Designed for use on IMMULITE 2000 immunoassay systems. Stability: 6 months at -20°C unopened; 8 hours at ambient temperature after opening.

Indications for Use

Indicated for monitoring system performance of the IMMULITE Immunoassay system for the quantitative measurement of Free PSA antigen. 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

• IMMULITE® 2000 PSA Calibration Verification Material (k131536)

Submission Summary (Full Text)

{0}

1

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

A. 510(k) Number:
k133816

B. Purpose for Submission:
New device

C. Measurand:
Calibration Verification Material (CVM) for IMMULITE® 2000 Free PSA antigen

D. Type of Test:
Not applicable

E. Applicant:
Siemens Healthcare Diagnostics Inc.

F. Proprietary and Established Names:
IMMULITE® 2000 Free PSA Calibration Verification Material

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:
Clinical Chemistry (75)

{1}

2

H. Intended Use:

1. Intended use(s):

The IMMULITE® 2000 Free PSA Calibration Verification Material (CVM) is intended for monitoring system performance of the IMMULITE Immunoassay system for the quantitative measurement of Free PSA antigen.

2. Indication(s) for use:

Same as Intended Use

3. Special conditions for use statement(s):

For prescription use only

4. Special instrument requirements:

IMMULITE® 2000 Systems

I. Device Description:

The CVM kit contains one set of four vials (LPFCVM 1-4), 2 mL each. LPFCVM1 contains bovine protein/buffer matrix with preservatives. CVM2 – CVM4 contain low, intermediate and high levels of Free PSA respectively, in bovine protein/buffer matrix with preservatives matrix. The CVMs are supplied in lyophilized form.

J. Substantial Equivalence Information:

1. Predicate device name(s) and 510(k) number(s):

IMMULITE® 2000 PSA Calibration Verification Material (CVM), k131536

2. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device
IMMULITE® 2000 Free PSA CVM | Predicate
IMMULITE®
2000 PSA CVM |
| Intended Use | The IMMULITE® 2000 Free PSA Calibration Verification Material (CVM) is intended for monitoring system performance of the IMMULITE Immunoassay system for the quantitative | Same |

{2}

| Similarities | | |
| --- | --- | --- |
| Item | Device IMMULITE® 2000 Free PSA CVM | Predicate IMMULITE® 2000 PSA CVM |
| | measurement of Free PSA antigen. | |
| Function | Quality Control material | Same |
| Traceability | Internal reference preparation | Same |
| Levels | 4 (zero, low, intermediate and high) | Same |
| Storage | Unopened: ≤20°C until the expiration date Opened: Use immediately after opening; discard any unused material | Same |
| Use | Single Use Only | Same |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Analyte | Free PSA | PSA |
| Form | Lyophilized | Liquid |
| Matrix | Bovine Serum Albumin | Processed (pH-treated) Chicken Serum |

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

GEN13640 Stability Testing of In Vitro Diagnostic Reagents (Version 2002)

Guidance for Industry - Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators

Guidance for Industry and FDA Staff- 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):

{3}

4

Traceability:

The IMMULITE Free PSA CVMs are traceable to the WHO NIBSC 1st International Standard 96/668 through internal reference calibrators.

Value Assignment:

IMMULITE® CVMs are value assigned using approved reference calibrators lot manufactured with qualified materials and measurement procedures. Each level of CVM was tested in six runs, three replicates per run for a total of 18 replicates using two different kit lots on four instruments. The values are assigned using a curve of assigned reference calibrators. The CVM values are calculated based on the recovered values for each run on each instrument independently. CVM values are then averaged across all systems. The Guideline Range (95% confidence interval) for each CVM level was established based on the Target Mean and ± 2 Standard Deviation (SD). The values in the table below are example of the target range for each CVM level for the lot tested.

| Level | Catalog number | Target Mean (ng/mL) | Guideline Target Mean± 2SD (ng/mL) | |
| --- | --- | --- | --- | --- |
| 1 | LPTSCVM1 | 0.00 | 0.00 | 0.07 |
| 2 | LPTSCVM2 | 0.20 | 0.17 | 0.22 |
| 3 | LPTSCVM3 | 1.45 | 1.29 | 1.61 |
| 4 | LPTSCVM4 | 24.40 | 22.00 | 26.80 |
| Assay range 0.07 – 25.0 ng/mL | | | | |

Value assignment is lot specific. Each lot of CVM quality control is tested for verification by calculating the recovery of patient samples, spiked patient samples and normal male samples and controls using the assigned value. The controls must fall within their target ranges.

Stability:

The stability studies were conducted to validate shelf life claim for the IMMULITE® 2000 Free PSA CVM on IMMULITE 2000 platforms. The CVMs are run as part of the calibrator stability testing. The CVMs are run in duplicates and the concentration value is determined from the reference internal material. One lot was tested for 42 months. Two additional lots were tested for six months. For all studies there is percent recovery of more than 90%. The claimed CVM stability is 6 months when stored at -20°C prior to opening, and for 8 hours at ambient temperature (room temperature) after opening. Each CVM is for single use only. Real time stability is ongoing.

{4}

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

{5}

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.

6