IMMULITE/IMMULITE 1000 PROGESTERONE CALIBRATION VERIFICATION (CVM)

K103683 · Siemens Healthcare Diagnostics · JJX · Apr 28, 2011 · Clinical Chemistry

Device Facts

• Record ID: K103683
• Device Name: IMMULITE/IMMULITE 1000 PROGESTERONE CALIBRATION VERIFICATION (CVM)
• Applicant: Siemens Healthcare Diagnostics
• Product Code: JJX · Clinical Chemistry
• Decision Date: Apr 28, 2011
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

For in vitro diagnostic use, for the calibration verification of the IMMULITE®/IMMULITE 1000 Progesterone assay (LKPW). For prescription use only

Device Story

Calibration verification material (CVM) for IMMULITE/IMMULITE 1000 Progesterone assay; consists of four vials containing low, intermediate, and high levels of progesterone in processed human serum plus a progesterone-free sample. Used in clinical laboratory settings by laboratory professionals to verify assay calibration and reportable range. Liquid form, ready to use; stored at 2-8°C. Provides reference points to ensure assay accuracy and performance within established specifications. Helps healthcare providers confirm reliability of patient progesterone test results.

Clinical Evidence

No clinical data. Bench testing only; traceability, value assignment, and stability validated following Siemens Healthcare Diagnostics procedures.

Technological Characteristics

Processed human serum spiked with progesterone; contains preservative (sodium azide <0.1 g/dL). Liquid form, ready-to-use. Storage 2–8°C. Traceable to internal standard using optical density-defined progesterone stock solution. No electronic or software components.

Indications for Use

Indicated for in vitro diagnostic use for calibration verification of the IMMULITE/IMMULITE 1000 Progesterone assay. No specific patient population, age, or gender constraints defined.

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

• ADVIA Centaur® Enhanced Estradiol (eE2) Master Curve Material (MCM) (K102904)

Submission Summary (Full Text)

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# APR 2 8 2011

# 510(k) Summary

Submitter information Contact person: Garo Mimaryan, Regulatory Technical Specialist

Address: Siemens Healthcare Diagnostics, Inc 511 Benedict Avenue Tarrytown, NY 10591

Phone: [phone] Fax:

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Date summary prepared: December 17, 2010

Device Trade or Proprietary Name: IMMULITE®/IMMULITE® 1000 Progesterone Calibration Verification Material (CVM)

Device Common/Usual Name or Classification Name: Single (Specified) Analyte Controls (Assayed And Unassayed)

Classification Number/Class: JJX / Class I

Classification Panel: Clinical Chemistry (75)

This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92.

The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________

## Predicate Devices:

| Device Name | ADVIA Centaur® Enhanced Estradiol (eE2)<br>Master Curve Material (MCM) |
|---------------|------------------------------------------------------------------------|
| Common name | ADVIA Centaur® Enhanced Estradiol (eE2)<br>Master Curve Material (MCM) |
| 510(k) Number | K102904 |
| Manufacturer | Siemens Healthcare Diagnostics |

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# Device Description:

IMMULITE/IMMULITE 1000 Progesterone assay is traceable to an internal standard manufactured using qualified materials and measurement procedures. Calibration Verification Material (CVM) is traceable to this standard. One set of four vials, 2 mL each, containing low, intermediate and high levels of progesterone in processed human serum, with preservative, and a progesterone-free sample. The Calibration Verifiers are supplied in liquid form, ready to use. Store unopened materials refrigerated at 2-8°C until expiration date. Stable at 2-8°C for 30 days after opening.

# Warnings and Precautions:

For in vitro diagnostic use.

Follow universal precautions, and handle all components as if capable of transmitting infectious agents. Source materials derived from human blood were tested and found nonreactive for syphilis; for antibodies to HIV 1 and 2; for hepatitis B surface antigen; and for antibodies to hepatitis C.

Sodium azide, at concentrations less than 0.1 g/dL, has been added as a preservative. On disposal, flush with large volumes of water to prevent the buildup of potentially explosive metal azides in lead and copper plumbing.

#### Statement of Intended Use:

For in vitro diagnostic use, for the calibration of the IMMULITE/IMMULITE 1000 Progesterone assay (LKPW).

#### Performance:

The traceability, value assignment, and stability of the IMMULITE/IMMULITE 1000 Progesterone calibration Verification Material (CVM) has been validated following procedures of Siemens Healthcare Diagnostics. These Progesterone CVMs are substantially equivalent to currently marketed devices with similar intended uses.

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# Comparison to the Predicate Device:

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Similarities and Differences between the devices and the predicate are shown below:

| | Device | Predicate |
|--------------|------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | IMMULITE/IMMULITE 1000<br>Progesterone CVM | ADVIA Centaur eE2 Master<br>Curve Material |
| Intended Use | For in vitro diagnostic use,<br>for the calibration verification<br>of the IMMULITE/IMMULITE<br>1000 Progesterone assay<br>(LKPW). | The ADVIA Centaur<br>Enhanced Estradiol Master<br>Curve Material is for in vitro<br>diagnostic use in the<br>verification of calibration and<br>reportable range in the<br>ADVIA Centaur® Enhanced<br>Estradiol (eE2) assay. |
| Matrix | Human Serum | Same |
| Storage | 2°C to 8°C | Same |
| Stability | Unopened – until expiration<br>date on the vial label | Same |

## Similarities

## Differences

| Item | Device | Predicate |
|-----------|--------------------------------------------|--------------------------------------------|
| | IMMULITE/IMMULITE 1000<br>Progesterone CVM | ADVIA Centaur eE2 Master<br>Curve Material |
| Form | Liquid | Lyophilized |
| Analytes | Progesterone | Estradiol |
| Stability | Opened - 30 days | Opened - 14 days |

#### Conclusions:

The IMMULITE/IMMULITE 1000 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 ADVIA Centaur eE2 Master Curve Material in intended use and matrix.

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the seal is a stylized graphic of a caduceus, a symbol often associated with healthcare and medicine. The caduceus is depicted with a staff entwined by two snakes and topped with wings.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Siemens Healthcare Diagnostics c/o Ernest Joseph 511 Benedict Avenue Tarrytown, NY 10591 USA

APR 2 8 2011

Re: k103683 Trade Name: IMMULITE®/IMMULITE 1000 Progesterone Calibration . Verification Material (CVM) Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (Assayed and Unassayed) Regulatory Class: Class I. Reserved Product Codes: JJX Dated: April 15, 2011 Received: April 18, 2011

Dear Mr. Joseph:

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, listing 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 such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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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 Diagnostic Device Evaluation and Safety 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/cdrh/industry/support/index.html.

Sincerely yours.

C.C.

Courtney Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indication for Use

510(k) Number (if known): K103683

Device Name: the IMMULITE®/IMMULITE 1000 Progesterone Calibration verification Material.

## Indication for Use:

For in vitro diagnostic use, for the calibration verification of the IMMULITE®/IMMULITE 1000 Progesterone assay (LKPW).

Prescription Use_X__ And/Or Over the Counter Use _________________________________________________________________________________________________________________________________________________________ ・(21 CFR Part 801 Subpart C) (21 CFR Part 801 Subpart D) .

(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 (OIVD)

Signature

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

510(k) K103683

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