The Behring Coagulation System (BCS) is an automated coagulation analyzer for in vitro diagnostic use in clinical laboratories. The instrument performs the following parameters: Prothrombin Time (PT), Activated Pattial Thromboplast Time (APTT), Antithrombin Illa, Batroxibin, D-dimer, Deficient Plasmas, Fibrinogen, Heparin, Plasminogen, Protein C-clotting, Protein C-chromogenic, Thrombin Time, Von Willebrand factor.

Device Description

The current BCS was determined to be substantially equivalent as a fully automated photometric coagulation analyzer in 510(k) notification K970431. The current BCS was cleared to perform coagulometric and chromogenic tests, such as the routine tests prothrombin time, partial thromboplastin time, and fibrinogen, as well as the special tests, single factor determination antithrombin IIIa, protein C and plasminogen. The modified BCS has the ability to perform coagulometric, chromogenic and immunochemical assays (e.g., latex enhanced turbidimetric test Advanced D-Dimer). The addition of the immunochemical measuring method is the subject of this modification.

AI/ML Overview

The provided text describes the Behring Coagulation System 510(k) Modification (K992959). The modification allows the system to perform immunochemical assays, specifically referencing the Advanced D-Dimer test.

Here’s a breakdown of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Correlation	Correlation Coefficient: 0.91 (between Advanced D-Dimer and Asserachrom® D-Di)
	Y-intercept: 0.54
	Slope: 0.98
Precision	Inter-assay precision: 0.8% to 3.8%
	Intra-assay precision: 1.3% to 3.0%

Note: The document does not explicitly state the pre-defined acceptance criteria (e.g., "correlation coefficient must be greater than X"). It only reports the results of the performance studies. The implication is that these results were deemed acceptable for substantial equivalence.

2. Sample Size and Data Provenance

Correlation Study:
- Test Set Sample Size: 316 samples
- Data Provenance: Not explicitly stated, but the submission is from Dade Behring Marburg GmbH (Germany) and Dade Behring Inc. (USA), suggesting data could be from either or both regions. The text does not specify if it was retrospective or prospective.
Precision Study:
- Test Set Sample Size: Not explicitly stated as a single number but involved "two levels of control material and two levels of human plasma pools."
- Data Provenance: Not explicitly stated.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention using experts to establish ground truth. The studies described are comparative in nature (comparing the modified device's performance to a predicate device or established methods).

4. Adjudication Method

The document does not mention any adjudication method.

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

No MRMC study was performed or reported. This device is an automated coagulation system and not an imaging or diagnostic device that would typically involve human reader interpretation for a MRMC study.

6. Standalone Performance Study

Yes, a standalone performance study was done. The Correlation and Precision studies are standalone performance evaluations demonstrating the device's accuracy and reproducibility. The comparison to the Asserachrom® D-Di for correlation and the NCCLS Guideline EP5-A for precision indicates an evaluation of the device's performance properties.

7. Type of Ground Truth Used

For the Correlation study: The "ground truth" was established by another commercially available and presumably validated assay, the Asserachrom® D-Di, which served as the reference method for comparison.
For the Precision study: The "ground truth" or reference was based on established control material and human plasma pools, evaluated according to NCCLS Guideline EP5-A.

8. Sample Size for the Training Set

The document does not mention any training set sample size. This device is an in vitro diagnostic instrument; typical AI/Machine Learning models that require distinct training and test sets are not explicitly described for its core functionality here. The "modification" refers to the ability to perform a new type of assay (immunochemical), which relies on established photometric principles rather than a learning algorithm that needs a training phase in the typical sense of AI.

9. How the Ground Truth for the Training Set was Established

As no training set is described (see point 8), the method for establishing ground truth for a training set is not applicable/not mentioned.

Summary

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Dade Behring Inc. Behring Coagulation System 510(k)-Modification

JAN 1 1 2000

510(k) Summary for Behring Coagulation System

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

1992959 The assigned 510(k) number is:

1. Manufacture's Name, Address, Telephone, and Contact Person, Date of Preparation:

Manufacturer:

Dade Behring Marburg GmbH Emil-von-Behring Str. 76 Marburg/Germany

Dade Behring Inc. Glasgow Site P.O. Box 6101 Newark, Delaware 19714 Attn: Rebecca S. Ayash

Preparation date:

Contact Information:

August 31, 1999

2. Device Name/ Classification:

Behring Coagulation System:

Multipurpose svstem for in vitro Coaqulation studies

Class II (864.5425)

Classification Number:

Identification of the Legally Marketed Device: 3.

Bio-Tek EL309 microplate reader (K842085)

4. Device Description:

ક. Device Intended Use:

The Behring Coagulation System performs quantitative assays of specific parameters in human citrated plasma.

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Dade Behring Inc. Behring Coagulation System 510(k)-Modification

1. Medical device to which equivalence is claimed and comparison information: There are a number of photometric analyzers for the measurement of immunochemical assays. One such product is the Bio-Tek EL309 microplate reader. This instrument is a photometric analyzer for measuring immuno complexes. The BCS is substantially equivalent in intended use and results obtained to the Bio-Tek EL309 microplate reader, which was the subject of 510(k) K842085. Both instruments use photometric technology at various wavelengths for the measurement of immuno complexes.

7. Device Performance Characteristics:

Correlation:

The Advanced D-Dimer assay was compared to the Asserachrom® D-Di by evaluating 316 samples ranging from 0.43 to 85.9 mg/l. A correlation coefficient of 0.91 was obtained, with a y-intercept value of 0.54 and a slope of 0.98.

Precision:

Precision studies were performed by the evaluation of two levels of control material and two levels of human plasma pools in a manner consistent with NCCLS Guideline EP5-A. The inter-assay precision ranged from 0.8 to 3.8%, while the intra-assay precision ranged from 1.3 to 3.0%.

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Image /page/2/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which consists of a stylized caduceus-like symbol with three intertwined strands. The emblem is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

JAN 1 1 2000

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Rebecca S. Ayash Manager, Regulatory Affairs, Biology Dade Behring, Inc. P.O. Box 6101 Newark, Delaware 19714

Re: K992959

Trade Name: Behring Coagulation System Regulatory Class: II Product Code: JPA Dated: December 6, 1999 Received: December 7, 1999

Dear Ms. Ayash:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrl/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D, M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Dade Behring Inc. Behring Coagulation System Additional Information 510(k) - K992959

Indications Statement

Behring Coagulation System Device Name:

Indications for Use:

The Behring Coagulation System (BCS) is an automated coagulation analyzer for in vitro diagnostic use in clinical laboratories. The instrument performs the following parameters:

· Prothrombin Time (PT)
·Activated Pattial Thromboplastin Time (APTT)
·Antithrombin Illa
•Batroxibin
·D-dimer
·Deficient Plasmas
·Fibrinogen
·Heparin
·Plasminogen
·Protein C-clotting
·Protein C-chromogenic
· Thrombin Time
.Von Willebrand factor

Rita E. Mader

(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number --

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter-Use_ (Optional Format 1-2-96)

000009

Regulation Number and Section

§ 864.5425 Multipurpose system for in vitro coagulation studies.

(a)
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.(b)
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.