STA - FREE PS CALIBRATOR

K092113 · Diagnostica Stago, Inc. · JIX · Nov 13, 2009 · Clinical Chemistry

Device Facts

• Record ID: K092113
• Device Name: STA - FREE PS CALIBRATOR
• Applicant: Diagnostica Stago, Inc.
• Product Code: JIX · Clinical Chemistry
• Decision Date: Nov 13, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

STA® - Free PS Calibrator kit is a set of calibrator plasmas intended for use with analyzers of the STA® line suitable to these reagents for the calibration of free protein S assays by the immuno-turbidimetric method, STA® - Liatest® Free PS.

Device Story

STA® - Free PS Calibrator kit consists of four lyophilized human plasma vials containing defined quantities of free protein S, buffer, and stabilizers. Used in clinical laboratory settings with STA® line IVD analyzers (STA-R®, STA Compact®) to establish calibration curves for immuno-turbidimetric free protein S assays. Reconstituted with water by laboratory technicians; loaded onto analyzers to enable quantitative measurement of free protein S in patient samples. Output is a calibration curve used by the analyzer to calculate patient protein S levels, aiding in the assessment of congenital or acquired protein S deficiency and associated thrombo-embolism risk.

Clinical Evidence

No clinical data. Bench testing only. Precision/reproducibility studies performed across multiple lots and instruments (STA-R, STA Compact) showed total CVs ranging from 1.7% to 7.6%. Stability confirmed for 4 hours reconstituted on-board and 18 months lyophilized at 2-8°C.

Technological Characteristics

Lyophilized human plasma; contains buffer and stabilizers. Immuno-turbidimetric calibration principle. Designed for use with STA® line IVD analyzers. Traceable to NIBSC International Standard 03/228.

Indications for Use

Indicated for use as calibrator plasmas for the calibration of free protein S assays on STA® line IVD analyzers. For prescription use only.

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• HemosIL™ Calibration Plasma (k041905)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for Stago. The logo consists of the word "Stago" in a serif font, with a stylized graphic above it. The graphic appears to be three curved shapes arranged in a circular pattern, creating a sense of motion or rotation. The logo is simple and modern, with a focus on the company name and a distinctive visual element.

# 92113

# Attachment - 4

## 510(k) SUMMARY

## Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared:

Umberto V. Parrotta Diagnostica Stago, Inc. Five Century Drive Parsippany, New Jersey 07054

NOV 1 8 2009

Phone: [phone]. x-2044 Facsimile: [phone]

Contact Person: Umberto V. Parrotta

Date Prepared: July 10, 2009

#### Name of Device and Name/Address of Sponsor:

STA® - Free PS Calibrator

Diagnostica Stago, Inc. Five Century Drive Parsippany, New Jersey 07054

#### Common or Usual Name:

- Secondary Calibrator. .
- IVD Calibrator.
- IVD Coagulation Calibration Device.

#### Classification Name:

- Calibrator, Secondary. .
#### Predicate Device:

- HemosIL™ (K041905). .
### Purpose of the Traditional 510(k) Notice:

- The STA® Free PS Calibrator is a new calibration kit for Free Protein S . assays using the STA® product line of IVD analyzers (STA-R® and STA Compact®).

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the word "Stago" in a serif font, with the letters slightly bolded. Above the word, there is a stylized graphic that resembles an abstract eye or a crescent moon shape. The graphic is positioned directly above the "t" in "Stago", creating a visual connection between the text and the symbol.

## 510(k) SUMMARY

#### Indication/Intended Use:

STA® - Free PS Calibrator kit is a set of calibrator plasmas intended for use with analyzers of the STA® line suitable to these reagents for the calibration of free protein S assays by the immuno-turbidimetric method, STA® - Liatest® Free PS.

### Technological Characteristics:

The STA® - Free PS Calibrator kit is a set of lyophilized human plasmas used to create the calibration curve on an IVD instrument performing the immunoturbidimetric method for free protein S assays, STA® - Liatest® Free PS. Such IVD instruments being the STA® product line of medical device analyzers such as STA-R® and STA Compact®.

In the lyophilized state and uncompromised primary packaging, the product calibrator plasmas remain stable for a period of 18 months from the date of manufacture when stored at 2 - 8°C. In the reconstituted state, STA® - Free PS Calibrator have demonstrated to be stable for 4 hours on board STA-R® and STA Compact®.

#### Substantial Equivalence:

The product, STA® - Free PS Calibrator and the predicate device, HemosILTM Calibration plasma are similar in indication/intended use, technology, principles of operation, and application of use (with IVD medical device analyzers) thus yielding no new questions in safety, effectiveness, or technology. In addition, performance data enclosed in this notice further demonstrates suitability for the intended use. Therefore, this concludes the product STA® Free PS Calibrator is substantially equivalent to the predicate device, HemosIL™ Calibration plasma.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Diagnostica Stago, Inc. c/o Mr. Umberto V. Parrotta Director of Regulatory Affairs and Quality Assurance 5 Century Drive Parsippany, NJ 07054

Re: k092113

NOV 1 3 2009

Trade/Device Name: STA - Free PS Calibrator Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: October 8, 2009 Received: October 9, 2009

Dear Mr. Parrotta:

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 class II (Special Controls), 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). This letter

{3}------------------------------------------------

Page 2 - Mr. Parrotta

will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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,

Qeena Philip

Ca

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

Enclosure

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the word "Stago" in a serif font. Above the word is a stylized graphic that appears to be an abstract shape, possibly resembling a stylized eye or a leaf. The graphic is positioned directly above the center of the word "Stago", creating a logo-like appearance.

## Attachment - 1

## Indications for Use

510(k) Number (if known):

K092113

Device Name:

STA® - Free PS Calibrator Kit

Indications for Use:

STA® - Free PS Calibrator kit is a set of calibrator plasmas intended for use with analyzers of the STA® line suitable to these reagents for the calibration of free protein S assays by the immuno-turbidimetric method, STA® - Liatest® Free PS.

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)

Reena Philip

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

510(k) k 092113