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 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.
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.

AI/ML Overview

Here's an analysis of the provided text regarding the STA®-Cephascreen Kit, focusing on acceptance criteria and the supporting study:

The document describes a 510(k) summary for the STA®-Cephascreen Kit, which is a reagent for determining activated partial thromboplastin time (APTT). The primary purpose of this submission is to demonstrate substantial equivalence to a predicate device, the STA®-C.K.Prest® kit.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" for the STA®-Cephascreen Kit in the traditional sense of numerical thresholds for sensitivity, specificity, or accuracy compared to a gold standard. Instead, the study aimed to demonstrate substantial equivalence to the predicate device.

The reported performance is based on the correlation between the new device and the predicate device.

Metric (Acceptance Criteria - implied by the comparative study)	Reported Device Performance (STA®-Cephascreen Kit vs. STA®-C.K.Prest® Kit)
Correlation Coefficient (r)	r = 0.943
Slope (a) of the regression line	a = 0.78
Y-intercept (b) of the regression line	b = 8.2
Interpretation: Substantial Equivalence	Based on the range of correlating data, STA®-Cephascreen® is substantially equivalent to the predicate device. This is the ultimate "acceptance" for a 510(k) submission.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: 125 plasma samples.
- 40 plasmas from presumed normal individuals
- 20 plasmas from patients receiving unfractionated heparin (UFH) therapy
- 20 plasmas from patients receiving low molecular weight heparin (LMWH) therapy
- 15 plasmas from patients receiving oral anticoagulant (AVK) therapy
- 10 LA positive plasma samples
- 10 plasmas from patients with factor VIII deficiency (F. VIII Def.)
- 10 plasmas from patients with factor IX deficiency (F. IX Def.)
Data Provenance: Not explicitly stated regarding country of origin. The manufacturer is French (Diagnostica Stago, France), but the distributor is in the US (Diagnostica Stago, Inc., Parsippany, NJ). The plasma types suggest clinical samples, but whether they were collected retrospectively or prospectively, or from what geographic region, is not specified. It's common for such studies to use retrospectively collected samples from a clinical lab specializing in coagulation.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

This type of study does not involve "experts" establishing a ground truth in the sense of image interpretation or diagnostic classification. Instead, the "ground truth" for the test set is established by the measurement value provided by the predicate device (STA®-C.K.Prest® kit). The study compares the new device's readings to those of the predicate. Therefore, information about the number and qualifications of experts is not applicable here.

4. Adjudication Method for the Test Set:

Not applicable. There is no adjudication method described as this is a comparative analytical performance study, not a diagnostic accuracy study relying on human interpretation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. This is an in-vitro diagnostic (IVD) device for laboratory testing, not an AI-powered diagnostic tool for human readers. Therefore, the concept of "human readers improving with AI vs. without AI assistance" does not apply.

6. Standalone Performance Study:

Yes, a standalone performance study was done implicitly. The STA®-Cephascreen Kit was used "exactly as described by their respective package inserts" to determine APTT values. The study then compared these standalone results to those obtained from the predicate device. The correlation data (r, a, b values) represent the analytical performance of the new device when used independently and compared to an established method.

7. Type of Ground Truth Used:

The "ground truth" for this study is the measurements obtained from the legally marketed predicate device, STA®-C.K.Prest® kit. The goal was to show that the new device produces results comparable to the predicate when measuring the same plasma samples. This is a common approach for demonstrating substantial equivalence for new IVD devices that perform the same function as existing ones.

8. Sample Size for the Training Set:

The document does not mention a "training set." This type of comparative analytical performance study for an IVD device does not typically involve machine learning or AI models requiring a training set in the conventional sense. The device is a reagent kit, not an algorithm that learns from data.

9. How Ground Truth for the Training Set Was Established:

Not applicable, as no training set is mentioned or implied for this type of IVD device study.

Summary

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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: 973-631-1618 www.stago-us.com

510K Summary

Distributor:

Diagnostica Stago, Inc. 5 Century Dr. Parsippany, NJ 07054 (973) 631-1200-116 Fax: (973) 631-1618

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

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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Page 2 -

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 (240) 276-0484. 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 (800) 638-2041 or (301) 443-6597 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

Division of

ghostic Deviceice

sio(k) K 653///

Page 1 of _

Regulation Number and Section

§ 864.7925 Partial thromboplastin time tests.

(a)
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.(b)
Classification. Class II (performance standards).