STA-CEPHASCREEN KIT

K053111 · Diagnostica Stago, Inc. · GFO · May 4, 2006 · Hematology

Device Facts

• Record ID: K053111
• Device Name: STA-CEPHASCREEN KIT
• Applicant: Diagnostica Stago, Inc.
• Product Code: GFO · Hematology
• Decision Date: May 4, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7925
• Device Class: Class 2

Intended Use

The STA® - Cephascreen® kits provide reagents for the determination of the activated partial thromboplastin time (APTT) in citrated plasma on the STA® line of analyzers suitable to these reagents.

Device Story

STA®-Cephascreen is an in vitro diagnostic reagent kit for determining activated partial thromboplastin time (APTT). The reagent contains cephalin (rabbit cerebral tissue-derived platelet substitute) and a polyphenolic activator in a buffered medium. Used on STA® line analyzers, the device facilitates recalcification of citrated plasma to initiate the coagulation cascade. The analyzer measures the time required for clot formation, which serves as a screening test for intrinsic and common coagulation pathway deficiencies or monitoring of anticoagulant therapies. The output is a time-based measurement used by clinicians to assess coagulation status, identify congenital or acquired deficiencies, and manage patients on heparin or oral anticoagulant therapy. The device is intended for professional use in clinical laboratory settings.

Clinical Evidence

Bench testing only. Precision: intra-assay CV ≤ 1%, inter-assay CV ≤ 1.5%. Method comparison (n=395) against predicate yielded r=0.94, y=0.81x+6.42. Sensitivity to UFH confirmed; minimal effect from LMWH; relative insensitivity to Lupus Anticoagulant demonstrated. Reference range established as 23.7–34.9 seconds based on 360 healthy individuals.

Technological Characteristics

Reagent kit containing cephalin (rabbit cerebral tissue) and polyphenolic activator in buffered medium. Liquid, ready-to-use form. Designed for use on STA® line automated coagulation analyzers. Stability: 15 months unopened at 2-8°C; 7-10 days on-board depending on vial size; 24 hours at 20±5°C; 14 days at 2-8°C once opened.

Indications for Use

Indicated for the determination of activated partial thromboplastin time (APTT) in citrated plasma to screen for intrinsic and common coagulation pathway deficiencies (factors XII, XI, IX, VIII, X, V, II, and fibrinogen) and to monitor anticoagulant therapies (heparin, oral anticoagulants, thrombin inhibitors) in patients requiring coagulation assessment.

Regulatory Classification

Identification

A partial thromboplastin time test is a device used for primary screening for coagulation abnormalities, for evaluation of the effect of therapy on procoagulant disorders, and as an assay for coagulation factor deficiencies of the intrinsic coagulation pathway.

Predicate Devices

• STA®-C.K.Prest® kit (K792048)

Submission Summary (Full Text)

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Kos3111

- 4 and

MAY

Image /page/0/Picture/1 description: The image shows the logo for Diagnostica Stago. The logo consists of a black square on the left, followed by the word "DIAGNOSTICA" in bold, black letters on the top line. Below that, the word "STAGO" is written in the same style.

DIAGNOSTICA STAGO, Inc

Five Century Drive Parsippany, NJ 07054 1-800-222-COAG 973-631-1200 Fax: [phone] www.stago-us.com

## 510K Summary

### Distributor:

Diagnostica Stago, Inc. 5 Century Dr. Parsippany, NJ 07054 [phone]-116 Fax: [phone]

For Diagnostica Stago, the French manufacturer located at: Diagnostica Stago 9, rue des Frères Chausson Boite Postal 226 92600 Asnières FRANCE

November 1, 2005

Trade Name: STA®-Cephascreen Kit Common Name: APTT Kit Classification Name: partial thromboplastin time (21 CFR 864.7925, Product code GFO)

### Substantial Equivalence:

The proposed STA®-Cephascreen Kit has been compared with the predicate device STA®-C.K.Prest® kit (K792048, Diagnostica Stago France)

STA®- Cephascreen 510K Summary

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Image /page/1/Picture/0 description: The image shows the logo for DIAGNOSTICA STAGO. The logo consists of a black square on the left and the words "DIAGNOSTICA" and "STAGO" in bold, black letters on the right. The words are stacked vertically, with "DIAGNOSTICA" on top and "STAGO" on the bottom.

DIAGNOSTICA STAGO, Inc

#### 1. Product Description

The STA®-Cephascreen kits provide reagents for the determination of the activated partial thromboplastin time (APTT) according to Langdell R.D. et al. (1) and Larrieu M. J., Weilland C. (2) by analyzers of the STA® line suitable to these reagents.

#### II. Explanation

The APTT is a general coagulation screening test of the intrinsic and common coagulation pathways (factors XII, XI, IX, VIII,X, V, II and fibrinogen).

A prolongation of the APTT is encountered in the following situations (7): -Congenital Deficiencies

- . If the prothrombin time (PT) is normal, the following factors may be deficient:
- o Factor VIII
- Factor IX ্ত
- Factor XI o
- o Factor XII
- If all these factors are normal, a deficiency in HMW kininogen ● (Fitzgerald factor) should be considered
- -Acquired Deficiencies
- Liver diseases ●
- Consumptive coagulopathy .
- Circulating anticoagulants (antiprothrombinase or circulating . anticoagulant against a factor)
- During heparin or oral anticoagulant therapy .
- Treatments with thrombin inhibitors (e.g., hirudin, argatroban ... ) �

#### III. Test Principle

The APTT involves the recalcification of plasma in the presence of a standardized amount of cephalin (platelet substitute) and a factor XII activator (polyphenolic component).

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Image /page/2/Picture/0 description: The image shows the logo for Diagnostica Stago, Inc. The logo consists of a black square on the left, followed by the words "DIAGNOSTICA" and "STAGO" stacked on top of each other in a bold, sans-serif font. Below the square and the words is the text "DIAGNOSTICA STAGO, Inc." in a smaller, serif font. The logo is simple and professional, and it is likely used to represent the company on its products and marketing materials.

#### IV. Kit Contents

STA®-Cephascreen ®: reagent containing cephalin (platelet substitute), prepared from rabbit cerebral tissues (2) and a polyphenolic activator (patent pending) in a buffered medium.

The STA®-Cephascreen ® is available in two different kit sizes:

- STA®-Cephascreen®©(REF00308) containing 12x4 mL vials ready for . use reagent
- STA®-Cephascreen®쓰(REF 00310) containing 12x10 mL vials of ready . for use reagent

The STA®-Cephascreen® reagents are provided in liquid form, ready for use after stabilization and mixing when a vial is opened.

#### V. Technological Characteristics as compared to STA®-C.K. Prest®

STA®-Cephascreen ® is engineered to be a screening test, using APTT to assist and clarify diagnoses. STA®-C.K.Prest ®, while extremely similar, is geared towards testing with factors.

While the bases of the two tests are very similar, different activators are used for the activation of the PTT. The predicate device uses kaolin, while STA®-Cephascreen ® uses a polyphenolic activator.

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Image /page/3/Picture/0 description: The image shows the logo for Diagnostica Stago. The logo consists of a black square on the left, followed by the word "DIAGNOSTICA" in bold, black letters. Below "DIAGNOSTICA" is the word "STAGO", also in bold, black letters. The text is slightly offset to the right of the black square.

DIAGNOSTICA STAGO, Inc.

#### VI. Substantial Equivalence

The proposed STA®-Cephascreen ® kits have been compared with the predicate device STA®-C.K.Prest ® (Diagnostica Stago, France K792048).

The two kits were used in parallel exactly as described by their respective package inserts to determine the activated partial thromboplastin time (APTT) in 125 plasmas comprising:

- plasmas from presumed normal individuals (n=40) .
- . plasmas from patients receiving unfractionated heparin (UFH) therapv (n=20)
- plasmas from patients receiving low molecular weight heparin (LMWH) . therapy (n=20)
- plasmas from patients receiving oral anticoagulant (AVK) therapy (n=15) ●
- LA positive plasma (n=10) .
- Plasmas from patients with factor VIII deficiency (F. VIII Def.) (n=10) .
- Plasmas from patients with factor IX deficiency (F. IX Def.) (n=10) .

The correlation of the data was as follows:

n=125 r=0.943 a=0.78

- b=8.2
Based on the range of correlating data , STA®-Cephascreen ® is substantially equivalent to the predicate device STA®-C.K.Prest ® as cleared under 510(k) number K792048.

#### V. Kit Storage and Stability

The reagent in intact (unopened) vials remains stable until the expiration date printed on the box, when stored at 2-8°C. This stability corresponds to a duration of l 5 months after the date of manufacture.

Once a vial is opened and prepared as indicated on the package insert, the reagent has demonstrated a stability of:

> -7 days (REF 00308) or 10 days (REF 00310) on STA®, STA Compact® and STA-R®

-24 hours at 20 ± 5 °C

-14 days at 2-8°C

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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 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 symbol.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY - 4 " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " "

DIAGNOSTICA STAGO, Inc. C/O Melissa M. Cole Executive and Regulatory Assistant Five Century Drive Parsippany, New Jersey 07054

Re: k053111

Trade/Device Name: STA® CephaScreen Regulation Number: 21 CFR 864.7925 Regulation Name: Partial Thromboplastin Time Test Regulatory Class: Class II Product Code: GFO Dated: 01 May 2006 Received: 02 May 2006

Dear Ms. Cole:

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 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); 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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This letter 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 Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

Robert Becker J

Robert L. Becker, Jr., MD PH.D Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K053111

Device Name: STA®- CEPHASCREEN

Indications For Use:

The STA® - Cephascreen® kits provide reagents for the determination of the activated partial thromboplastin time (APTT) in citrated plasma on the STA® line of analyzers suitable to these reagents.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

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

Jauphin Brutted
Division State of Utah
DIVISION of OIL

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