STA- COAG CONTROL (N+ABN) PLUS

K120014 · Diagnostica Stago, Inc. · GGN · Mar 14, 2013 · Hematology

Device Facts

• Record ID: K120014
• Device Name: STA- COAG CONTROL (N+ABN) PLUS
• Applicant: Diagnostica Stago, Inc.
• Product Code: GGN · Hematology
• Decision Date: Mar 14, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Intended Use

The STA® - Coag Control (N +ABN) PLUS is a kit containing assayed normal and abnormal plasmas intended for the quality control of the following quantitative tests on STA-R® and STA Compact® analyzers: prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen, thrombin time (TT), and antithrombin (AT).

Device Story

STA-Coag Control (N + ABN) PLUS is a kit of two levels of lyophilized, citrated human plasma (normal and abnormal). Used as quality control material for coagulation assays (PT, APTT, fibrinogen, TT, AT) on STA-R and STA Compact analyzers. Analyzers use chronometric (viscosity-based) detection for clotting assays and photometric (absorbance) detection for chromogenic assays. Reconstituted with distilled water; stable for 24 hours on-board. Healthcare providers use control results to verify analyzer performance and ensure accuracy of patient test results.

Clinical Evidence

No clinical data. Bench testing only. Precision studies performed per CLSI EP5-A2 across three sites using three lots on STA-R and STA Compact analyzers. Stability studies (open-vial and closed-vial) performed per CLSI EP25-A to support 24-hour on-board and 24-month shelf-life claims. All results met pre-determined acceptance criteria.

Technological Characteristics

Lyophilized citrated human plasma. Reconstituted with distilled water. Analyzers utilize chronometric (viscosity-based) and photometric (absorbance) detection principles. 24-month shelf-life at 2-8°C. 24-hour on-board stability.

Indications for Use

Indicated for quality control of PT, APTT, fibrinogen, TT, and AT assays on STA-R and STA Compact analyzers using normal and abnormal citrated human plasma controls.

Regulatory Classification

Identification

A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.

Special Controls

*Classification.* Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

Predicate Devices

• STA® - System Control N + P (k943518)

Submission Summary (Full Text)

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KiZOOIY.

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MAR 1 4 2013

#### 510(k) Summary

### Submitter's Information

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

Phone Number: 973 631-1200 Fax Number: 973 867-6859

Date Prepared: March 1, 2013

Contact Person:

Delphine Ysvelain

Regulatory Affairs Manager

Device Name: STA® - Coag Control (N + ABN) PLUS

Device Classification: Class II

Regulation Number: 21 CFR 864.5425 Panel: Hematology (81) Product Code: GGN

Predicate Device: STA® - System Control N + P - K943518 Manufacturer: Diagnostica Stago (Formerly known as American Bioproducts)

Device Intended Use:

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Image /page/1/Picture/0 description: The image shows the word "Stago" in a serif font, with the "S" capitalized and the rest of the letters in lowercase. Above the word "Stago" is a stylized graphic element. The graphic element appears to be composed of three curved shapes arranged in a circular or triangular pattern, with each shape being black and solid.

The STA - Coag Control @ +ABN) PLUS is a kit containing assayed normal and abnormal plasmas intended for the quality control of the following quantitative tests on STA-R and STA Compact analyzers: prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen, thrombin time (TT), and antithrombin (AT).

#### Device description:

The STA® - Coag Control (N + ABN) PLUS kit is a set of two control levels.

Each kit provides:

o 12 x 2-ml vials of Reagent 1 (STA® - Coag Control N PLUS), citrated normal human plasma, lyophilized.

0 12 x 2-ml vials of Reagent 2 (STA® - Coag Control |ABN PLUS), citrated abnormal human plasma, lyophilized.

STA® - Coag Control (N+ |ABN) PLUS Reagents are used as controls for clotting assays (PT, APTT, fibrinogen, and TT) and chromogenic assays (AT) performed on analyzers of the STA® line.

Analyzers of the STA® line utilize the chronometric principle (viscosity based detection system) for clotting tests while the chromogenic assays are based on the photometric method (measurement of absorbance of monochromatic light).

Statement of technological characteristics of the device compared to predicate device:

STA® - Coag Control (N+ ABN) PLUS is substantially equivalent to its predicate device, STA® - System Control N + B (K943518), based on similar intended use, technology and principles of operation, thus yielding no new questions in safety, effectiveness or technology.

#### Summary Performance Characteristics

#### Precision

Precision studies were performed according to the CLSI guideline EPS-A2. STA - Coag Control N PLUS and ABN PLUS were tested for 20 days, 2 runs per day, in duplicate on STA-R and STA Compact .

The following results have been obtained

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| • on STA-R® | Repeatability CV(%) | Within-Laboratory precision CV (%) | | |
|-------------------------------------------------|----------------------|------------------------------------|--------|----------|
| | N PLUS | ABN PLUS | N PLUS | ABN PLUS |
| PT (in sec.)<br>with STA®- Neoplastine® CI | 0.9 | 0.6 | 1.1 | 2.0 |
| PT (in sec.)<br>with STA®- Neoplastine® CI Plus | 0.9 | 0.5 | 1.1 | 1.9 |
| APTT (in sec.)<br>with STA®- C.K. Prest® | 0.6 | 0.8 | 1.3 | 1.8 |
| APTT (in sec.)<br>with STA®- Cephescreen® | 0.7 | 0.7 | 2.1 | 1.9 |
| APTT (in sec.)<br>with STA®- PTT A | 0.9 | 1.0 | 2.6 | 1.9 |
| Fibrinogen (in g/l)<br>with STA®- Fibrinogen | 2.4 | 4.2 | 3.5 | 5.5 |
| TT (in sec.)<br>with STA®- Thrombin | 2.4 | 1.9 | 2.8 | 3.4 |
| AT (in %)<br>with STA®- Stachrom® AT III | 1.9 | 3.9 | 3.6 | 5.3 |
| • on STA Compact® | Repeatability CV (%) | Within-Laboratory precision CV (%) | | |
| | N PLUS | ABN PLUS | N PLUS | ABN PLUS |

| | N<br>PLUS | ABN<br>PLUS | N<br>PLUS | ABN<br>PLUS |
|-----------------------------------------------------------------------|-----------|-------------|-----------|-------------|
| PT (In sec.)<br>with STA ® - Neoplastine® Cl | 1.4 | 0.7 | 2.3 | 2.1 |
| PT (In sec.)<br>with STA ® - Neoplastine® Cl Plus | 1.5 | 1.1 | 2.3 | 2.0 |
| APTT (In sec.)<br>with STA ® - C.K. Prest® | 1.2 | 1.0 | 2.3 | 2.1 |
| APTT (In sec.)<br>with STA ® - Cephascreen® | 1.6 | 1.1 | 2.3 | 1.8 |
| APTT (In sec.)<br>with STA ® - PTT [Image: square with diagonal line] | 1.3 | 0.8 | 3.1 | 1.7 |
| Fibrinogen (In g/l)<br>with STA ® - Fibrinogen | 4.1 | 2.0 | 5.2 | 3.8 |
| TT (In sec.)<br>with STA ® - Thrombin | 1.3 | 1.4 | 3.5 | 5.4 |
| AT (In %)<br>with STA ® - Stachrom® AT III | 2.7 | 2.8 | 4.6 | 4.4 |

Substantial Equivalence Comparison Table:

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| Similarities | | |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | Subject Device<br>STA® - Coag Control<br>(N + ABN) PLUS | Predicate Device<br>STA® - System Control N +<br>P<br>K943518 |
| Intended Use | For the quality control of the<br>following coagulation assays:<br>prothrombin time (PT),<br>activated partial thromboplastin<br>time (APTT), fibrinogen,<br>thrombin time (TT) and<br>antithrombin (AT) in the normal<br>and abnormal ranges. | Same, except:<br>- additional analytes claimed<br>for the intended use in the<br>normal and abnormal ranges<br>- the thrombin time is<br>determined in the normal range<br>only. |
| Number of levels<br>per set | 2 (one normal and one<br>abnormal) | Same |
| Matrix | Citrated Human plasma | Same |
| Form | Lyophilized | Same |
| Reagent<br>preparation | Reconstitution with distilled<br>water | Same |

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Image /page/3/Picture/0 description: The image shows the word "Stago" in a serif font, with the first letter capitalized and the rest in lowercase. Above the word is a stylized graphic element that resembles a crescent shape with a small gap, creating a sense of movement or rotation. The logo is simple and clean, with a focus on the text and the abstract symbol above it.

| Similarities | | |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | Subject Device<br>STA® - Coag Control<br>( <span style="border:1px solid black">N</span> + <span style="border:1px solid black">ABN</span> ) PLUS | Predicate Device<br>STA®-System Control <span style="border:1px solid black">N</span> +<br><span style="border:1px solid black">P</span><br>K943518 |
| Principle of<br>operation | Used as controls for clotting<br>assays (PT, APTT, fibrinogen,<br>and TT) and chromogenic<br>assays (AT) | Same |
| Analyzers | STA-R®<br>STA Compact® | Same as well as STA Satellite® |
| Shelf-life | 24 months at 2-8 °C in intact<br>vials | Same |
| Differences | | |
| Item | Subject Device<br>STA® - Coag Control<br>( <span style="border:1px solid black">N</span> + <span style="border:1px solid black">ABN</span> ) PLUS | Predicate Device<br>STA® - System Control <span style="border:1px solid black">N</span> +<br><span style="border:1px solid black">P</span><br>K943518 |
| Reconstituted<br>Reagent stability | 24 hours on-board analyzers | 8 hours on-board analyzers |

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Carolina Career States

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in all capital letters.

#### Public Health Service

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

March 14, 2013

Diagnostica Stago, Inc. c/o Ms. Delphine Ysvelain Regulatory Affairs Associate 5 Century Drive Parsippany, New Jersey 07054

Re: k120014

Trade/Device Name: STA® - Coag Control (N + ABN) PLUS Regulation Number: 21 CFR § 864.5425 Regulation Name: Multipurpose system for in vitro coagulation studies Regulatory Class: Class II Product Code: GGN Dated: March 6, 2013 Received: March 7, 2013

Dear Ms. Ysvelain:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

# Maria M. Chan -S

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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Image /page/6/Picture/0 description: The image shows the logo for Stago. The logo consists of the word "Stago" in a simple, sans-serif font, with a stylized graphic above it. The graphic is a circular shape with three curved segments removed, creating a dynamic, almost floral appearance. The logo is simple and modern.

## 10.0 INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K120014

Device Name: STA® - Coag Control (N + ABN) PLUS

Indications for Use:

The STA® - Coag Control @ + ABN) PLUS is a kit containing a normal plasma and an abnormal plasma intended for the quality control of the following tests on STA-R® and STA Compact analyzers: prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen, thrombin time (TT), and antithrombin (AT).

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

> Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) .

Leonthena R. Carrington -S

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

510(k)__K120014