IMMULITE 1000 THIRD GENERATION PSA CALIBRATION VERIFICATION MATERIAL

K122534 · Siemens Healthcare Diagnostics, Inc. · JJX · Mar 14, 2013 · Clinical Chemistry

Device Facts

• Record ID: K122534
• Device Name: IMMULITE 1000 THIRD GENERATION PSA CALIBRATION VERIFICATION MATERIAL
• Applicant: Siemens Healthcare Diagnostics, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Mar 14, 2013
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The IMMULITE®/IMMULITE 1000 Third Generation PSA Calibration Verification Material (CVM) is intended for monitoring system performance of the IMMULITE Immunoassay system for the quantitative measurement of PSA antigen.

Device Story

The IMMULITE/IMMULITE 1000 Third Generation PSA Calibration Verification Material (CVM) is a quality control product consisting of four vials containing processed chicken serum matrix with varying concentrations of PSA (0 to high levels). It is used in clinical laboratory settings to monitor the performance of the IMMULITE Immunoassay system. The device does not perform measurements itself; rather, it serves as a reference material to verify the accuracy and stability of the immunoassay system's quantitative measurement of PSA antigen in human serum. Healthcare providers use the recovered values from the CVM to ensure the system remains within established performance limits, thereby supporting the reliability of patient PSA test results used in clinical decision-making.

Clinical Evidence

No clinical data. Bench testing only. Performance was established through value assignment using 27 replicates per level across 2 kit lots and 9 instruments. Stability was validated through real-time studies at -20°C for up to 90 days. Matrix effects were evaluated via spiking recovery studies, confirming mean recovery within ±15% of target.

Technological Characteristics

Quality control material consisting of processed chicken serum matrix with buffering salts and PSA. Form factor: 4 vials, 3 mL each. Storage: -20°C. Traceability: Internal reference preparation. No inherent sensing or energy source; used as a reagent for fluorescence immunoassay systems.

Indications for Use

Indicated for monitoring system performance of the IMMULITE Immunoassay system for the quantitative measurement of 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

• Access Hybritech p2PSA QC (k112603)

Submission Summary (Full Text)

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siemens

Abbreviated 510(k) Premarket Notification

IMMULITE®/IMMULITE 1000 Third Generation PSA Calibration Verification Material

# MAR 1 4 2013

# 5. 510(k) Summary as Required by 21 CFR 807.92

| A. 510(k) Number: | K122534 |
|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| B. Purpose for Submission: | New Device |
| C. Measurand: | Quality Control materials for the IMMULITE®/IMMULITE<br>1000 Third Generation PSA assay (LKUP) |
| D. Type of Test: | Calibration Verification Material (CVM) for<br>IMMULITE®/IMMULITE 1000 Third Generation PSA assay |
| E. Applicant: | |
| 1. Address: | Siemens Healthcare Diagnostics Inc.<br>511 Benedict Avenue<br>Tarrytown, NY 10591 |
| 2. Contact Person: | Garo Mimaryan, MS, RAC<br>Technical Regulatory Affairs Specialist III |
| 3. Phone Number: | (914)-524-3270 |
| F. Proprietary and<br>Established Names: | IMMULITE®/IMMULITE 1000 Third Generation PSA<br>Calibration Verification Material |
| G. Regulatory Information: | |
| 1. Regulation Section: | 21 CFR 862.1660, Quality Control Material |
| 2. Classification: | Class I |
| 3. Products Codes: | JJX - Single (Specified) Analyte Controls (Assayed and<br>Unassayed) |
| 4. Panel: | Clinical Chemistry (75) |
| H. Intended Use: | |
| 1. Intended Use(s): | See Indications for Use below. |
| 2. Indications for Use: | The IMMULITE®/IMMULITE 1000 Third Generation PSA<br>Calibration Verification Material (CVM) is intended for<br>monitoring system performance of the IMMULITE<br>Immunoassay System for the quantitative measurement of<br>PSA antigen. |
| 3. Special Conditions for<br>Use Statement(s). | For prescription use only. |
| 4. Special Instrument<br>Requirements: | IMMULITE®/IMMULITE 1000 Systems |
| I. Device Description: | The Calibration Verification Material (CVM) contains one set<br>of four vials, 3 mL each. L3PSCVM1 contains processed<br>chicken serum matrix with preservative. L3PSCVM2,<br>L3PSCVM3 and L3PSCVM4 contain low, intermediate and<br>high levels of PSA respectively, in processed chicken serum<br>matrix with preservative. |

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Abbreviated 510(k) Premarket Notification IMMULITE®IMMULITE 1000 Third Generation PSA Calibration Verification Material

- J. Substantial Equivalence
### Information:

- Access Hybritech p2PSA QC 1. Predicate Device Name:
- 2. Predicate 510(k) No.
- k112603
- A comparison of the device features, intended use, and other 3. Comparison with information demonstrates that the IMMULITE®/ IMMULITE Predicate: 1000 PSA Calibration Verification Material (CVM) is substantially equivalent to the predicate device, Access Hybritech p2PSA QC, as summarized in the following table.

| REAGENT SIMILARITIES and DIFFERENCES | | |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Candidate Device | Predicate Device |
| | IMMULITE/IMMULITE 1000 Third<br>Generation PSA CVM | Access Hybritech p2PSA QC |
| Intended<br>Use | The IMMULITE®/IMMULITE 1000<br>Third Generation PSA Calibration<br>Verification Material (CVM) is<br>intended for monitoring system<br>performance of the IMMULITE<br>Immunoassay system for the<br>quantitative measurement of PSA<br>antigen. | The Access Hybritech p2PSA QC<br>are tri-level controls intended for<br>monitoring system performance of<br>immunoenzymatic procedures for<br>the quantitative measurement of [- 2]pro PSA isoform of Prostate<br>Specific Antigen (PSA) using the<br>Access Immunoassay Systems. |
| Analyte | PSA | [-2]proPSA isoform of Prostate<br>Specific Antigen (PSA) |
| Form | Liquid | Same |
| Stability | Stable until the expiration date when<br>stored frozen. | Stable until the expiration date when<br>stored frozen. |
| Storage | -20°C | -20°C or colder |
| Matrix | Processed (pH-treated) Chicken Serum | Bovine Serum Albumin and<br>buffering salts |
| Use | Single Use Only | Not for Single Use |

# K. Standard/Guidance Documents Referenced:

- CEN 13640 Stability Testing of In Vitro Diagnostic Reagents ●
- 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

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### M. Performance Characteristics

- 1. Analytical Performance:
- a. Precision/Reproducibility: Not Applicable
- b. Linearity/assay Reportable Range: Not Applicable

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

Traceability: The IMMULITE Third Generation PSA Calibration Verification Materials are traceable to Gold Standards prepared using purified PSA antigen stock solution which had its concentration defined by optical density. The CVMs are manufactured using qualified materials and measurement procedures.

Stability: The IMMULITE®/IMMULITE 1000 Third Generation Calibration Verification Materials are stable up to 12 months when stored frozen at -20°C prior to opening. Unopened stability is indicated by expiration date on the label when stored at -20°C.

Value Assignment: The IMMULITE CVMs are value assigned using a previous reference lot of materials. Standards are prepared using the purified (≥98% purity) PSA antigen stock solution whose concentration was defined by optical density. The CVMs are manufactured using qualified materials and measurement procedures. The CVMs are tested on a minimum of nine runs comprised of a minimum of three systems and two different reagent kit lots. CVM values are derived by data reduction for each run on each instrument. CVM values are then averaged across all systems.

Production lots of CVMs are value assigned against the previous reference lot using two reagent kit lots and on a minimum of three different instruments. Quality control is performed by calculating the recovery of patient sample panels and controls using the assigned calibrator and CVM values. The calibrator values are calculated based on the recovered values for each run independently. Three levels of commercially available controls, twenty-five spiked human serum samples and five male patient samples are used to validate CVM value assignments.

The spiking recovery of the IMMULITE®/IMMULITE 1000 Third Generation PSA Calibration Verification Material (CVM) was determined to investigate potential matrix effects from using processed (pH-treated) Chicken Serum. Siemens spiked three concentrations of purified PSA antigen into human serum and an evaluation lot comprised of chicken serum. The PSA values of the evaluation lot were compared to the human serum lots. The acceptance criteria were 100% ±15% with an overall average of ±10%. Each of the samples met the acceptance criteria, and Siemens concluded that there were no matrix effects.

- Detection limit: Not Applicable d.
- Analytical Specificity: Not Applicable e.
- Assay cut-off: Not Applicable f.

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SIEMENS

IMMULITE®/IMMULITE 1000 Third Generation PSA Calibration Verification Material

- Comparison Studies 2.
a. Method Comparison with predicate device: Not Applicable

- b. Matrix Comparison: Not Applicable
- Clinical Studies: 3.
- a. Clinical Sensitivity and Specificity: Not Applicable
- b. Other clinical supportive data (when a. and b. are not applicable): Not Applicable
- Clinical Cut-off: Not Applicable 4.
- 5. Expected Values/Reference Range:

Each CVM level was tested for a total of 27 replicates; 9 runs and 3 replicates per run. 2 different reagent kit lots and 9 different instruments were used to gain the 27 replicates. The Guideline Range (95% confidence interval) for each CVM level was established based on the Target Mean and ± 2 Standard Deviation (SD). The expected values are provided in the IMMULITE®/IMMULITE 1000 PSA Calibration verification Material lot-specific value sheet. The expected assay range is 0.015 - 20 ng/mL. The values below can be considered as guidelines.

| Level | Catalog and<br>Lot number | Target<br>Mean<br>(ng/mL) | SD | Guideline Range<br>(ng/mL) | |
|-------|---------------------------|---------------------------|--------|----------------------------|-------|
| 1 | L3PSCVM1 D101 | 0.000 | | ≤ 0.005 | |
| 2 | L3PSCVM2 D101 | 0.085 | 0.0065 | 0.072 | 0.098 |
| 3 | L3PSCVM3 D101 | 4.45 | 0.2225 | 4.01 | 4.90 |
| 4 | L3PSCVM4 D101 | 18.6 | 1.4 | 15.8 | 21.4 |

#### Expected Values:

Each laboratory should establish their limits for acceptability based on methodology, clinical significance and medical decision levels of the test analyte. The representative, total precision tabulated in the respective assay instructions for use may be considered as one factor when establishing local, acceptable ranges. The values provided above may be considered as guidelines. Value assignment is lot specific.

#### N. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10

O. Conclusion: The IMMULITE®/IMMULITE 1000 PSA Calibration verification Material is substantially equivalent to other products in commercial distribution intended for similar use. Most notably, it is substantially equivalent to the currently marketed Access Hybritech p2PSA QC.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a circular design with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. Inside the circle is a stylized representation of an eagle, which is a common symbol of the United States.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

March 14, 2013

Siemens Healthcare Diagnostics Inc. c/o Mr. Garo Mimaryan Regulatory Affairs Specialist III 511 Benedict Avenue Tarrytown, NY 10591

Re: k122534

Trade/Device Name: IMMULITE®/IMMULITE 1000 Third Generation PSA Calibration Verification Material Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (assayed and unassayed) Regulatory Class: Class I Product Code: JJX Dated: March 5, 2013 Received: March 8, 2013

Dear Mr. Mimaryan:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrl/industrv/support/index.html.

Sincerely yours,

Image /page/5/Picture/5 description: The image shows the name "Maria M. Chan -S" in a simple, sans-serif font. The text is horizontally oriented and appears to be a signature or label. The letters are clear and legible, with a consistent stroke weight.

Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indication for Use

510(k) Number (if known): k122534

Device Name: IMMULITE®/IMMULITE 1000 Third Generation PSA Calibration Verification Material

#### Indication for Use:

The IMMULITE®/IMMULITE 1000 Third Generation PSA Calibration Verification Material (CVM) is intended for monitoring system performance of the IMMULITE Immunoassay system for the quantitative measurement of PSA antigen.

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)

MariaM.Chan-S

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

k122534 510(k)