BCS SYSTEM

K013114 · Dade Behring, Inc. · JPA · Nov 9, 2001 · Hematology

Device Facts

• Record ID: K013114
• Device Name: BCS SYSTEM
• Applicant: Dade Behring, Inc.
• Product Code: JPA · Hematology
• Decision Date: Nov 9, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Intended Use

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

Device Story

BCS™ System is a fully automated photometric coagulation analyzer for clinical laboratory use. It processes human citrated plasma samples to perform coagulometric, chromogenic, and immunochemical assays. The system automates the measurement of various coagulation parameters, providing quantitative results to clinicians for diagnostic assessment of hemostasis and coagulation disorders. By streamlining testing workflows, the device aids in the rapid evaluation of patient coagulation status, supporting clinical decision-making for conditions involving clotting or bleeding risks.

Clinical Evidence

Bench testing only. Method comparison study evaluated 194-202 plasma samples comparing the modified BCS™ System to the Sysmex® CA-6000 System. Results showed high correlation coefficients (r) ranging from 0.956 to 0.967 across various assays, including LA1 screening, LA2 confirmation, and LA1/LA2 ratios.

Technological Characteristics

Automated photometric coagulation analyzer. Performs coagulometric, chromogenic, and immunochemical tests. Analyzes human citrated plasma. System architecture supports high-throughput clinical laboratory testing.

Indications for Use

Indicated for in vitro diagnostic use in clinical laboratories for the quantitative analysis of coagulation parameters in human citrated plasma, including APTT, Antithrombin IIIa, Batroxobin, D-dimer, Deficient Plasmas, Derived Fibrinogen, Factor V Leiden, Fibrinogen, Heparin, Lupus Anticoagulants, Prothrombin Time (PT), Plasminogen, Protein C-clotting, Protein C-chromogenic, Thrombin Time, and von Willebrand factor.

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

• Sysmex® CA-6000 System (K001145)

Submission Summary (Full Text)

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Dade Behring Inc. Svstem 510(k)-Modification

# NOV 0 92001

# 510(k) Summary for BCS™ 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.

The assigned 510(k) number is: K013114

### Manufacturer's Name, Address, Telephone, and Contact Person, Date of 1. 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

September 13, 2001

Preparation date:

Contact Information:

### Device Name/ Classification: 2.

Multipurpose system for in vitro BCS™ System: Coagulation studies Class II (864.5425) Classification Number:

### Identification of the Legally Marketed Device: 3.

Sysmex® CA-6000 System (K001145)

#### Device Description: 4.

The current BCS™ System was originally determined to be substantially equivalent as a fully automated photometric coagulation analyzer in 510(k) Premarket Notification 14.1 Subsequent to its clearance, the indications for use of the instrument was modified under 510(k) Premarket Notifications, K992959, K000973 and K002080 for the modified under 510(R) I Temarket Nothlouisms, Roseson, I s cleared to perform coagulometric, chromogenic, and immunochemical tests, such as the routine tests: orothrombin time, partial thromboplastin time, heparin, and fibrinogen, as well as the special tests: single factor determination, antithrombin IIIa, batroxobin, plasminogen, protein C, and D-dimer.

#### Device Intended Use: ક.

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

000063

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- Medical device to which equivalence is claimed and comparison information: 6. The BCS" System is substantially equivalent in intended use and results obtained to the The BOO System to Saberanhich was the subject of 510(k) K001145.
### Device Performance Characteristics: 7.

### Correlation:

Correlation:
The modified BCS™ System comparison study evaluated plasma samples on the BCS™
1 and The modified DOO "Oystom oomaanson other State Behring LA 1 and System will the Dude Sysmex® CA-6000 System.

| Assay | Sample<br>Number (n) | Coefficient of<br>Correlation (r) | Regression<br>Equation |
|---------------------------------------|----------------------|-----------------------------------|------------------------|
| LA1 Screening Reagent (seconds) | 202 | 0.967 | y = 0.84 x + 1.05 |
| LA1 Screening Reagent (normalized) | 202 | 0.967 | y = 0.99 x + 0.01 |
| LA2 Confirmation Reagent (seconds) | 196 | 0.956 | y = 0.69 x + 1.65 |
| LA2 Confirmation Reagent (normalized) | 196 | 0.956 | y = 0.96 x + 0.04 |
| LA1/LA2 Ratio | 194 | 0.964 | y = 1.19 x - 0.00 |
| LA1/LA2 Ratio (normalized) | 194 | 0.964 | y = 1.00 x + 0.00 |

### Method Comparison Summary BCS™ System vs. Sysmex® CA-6000 System

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized graphic of three human profiles facing to the right, with the profiles overlapping each other.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Kathleen Dray-Lyons Manager, Regulatory Affairs NOV 0 9 2001 DADE BEHRING, INC. P.O. Box 6101 Newark, Delaware 19714

Re: K013114

> Trade Name: BCSTM System Regulation Number: 21 CFR § 864.5425 Regulation Name: Multipurpose System for in vitro Coagulation Studies Regulatory Class: II Product Code: JPA, GGP, GIR Dated: October 10, 2001 Received: October 16, 2001

Dear Ms. Ayash:

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 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 If you desire specific devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, (201) 59 mtact the Office of Compliance at [phone]. Also, please note the regulation entitled "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mormation on your rospon and Consumer Assistance at its toll-free number [phone] or 1301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

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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# NOV 0 92001

# Indications Statement

K013114

Device Name:

BCS™ System

## Indications for Use:

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

- · Activated Partial Thromboplastin Time (APTT)
- · Antithrombin Illa
- Batroxobin
- · D-dimer
- · Deficient Plasmas
- · Derived Fibrinogen
- Factor V Leiden
- · Fibrinogen
- · Heparin
- · Lupus Anticoagulants
- · Prothrombin Time (PT)
- · Plasminogen
- · Protein C-clotting
- · Protein C-chromogenic
- Thrombin Time
- von Willebrand factor

Qitte Mchue C for T. BAUTISTA

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K013/14

(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)