BCT SYSTEM

K011665 · Dade Behring, Inc. · JPA · Aug 9, 2001 · Hematology

Device Facts

• Record ID: K011665
• Device Name: BCT SYSTEM
• Applicant: Dade Behring, Inc.
• Product Code: JPA · Hematology
• Decision Date: Aug 9, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Indications for Use

The Behring Coagulation Timer Analyzer (BCT™) System is an automated blood plasma coagulation analyzer for in vitro diagnostic use.

Device Story

BCT™ System is an automated in vitro diagnostic coagulation analyzer used in clinical laboratories. It processes blood plasma samples to perform various coagulation assays, including the detection of lupus anticoagulants. The device utilizes light at various wavelengths to measure coagulation parameters. It functions as a standalone instrument operated by laboratory personnel. The system provides quantitative results for coagulation tests, which clinicians use to assess patient coagulation status and inform clinical decision-making regarding hemostasis and anticoagulant therapy. The modification described adds the capability to test for lupus anticoagulants without altering the underlying hardware, principle of operation, or software logic.

Clinical Evidence

Bench testing only. Method comparison study evaluated 206-208 plasma samples comparing BCT™ System results to Sysmex® CA-6000 System using LA 1 and LA 2 reagents. Correlation coefficients (r) ranged from 0.882 to 0.969. Precision studies conducted per NCCLS EP5-A using three levels of control material showed total %CV ranging from 1.0% to 2.2%.

Technological Characteristics

Automated coagulation analyzer; optical sensing principle using light at various wavelengths; in vitro diagnostic use. No hardware or principle of operation modifications were made for the addition of the lupus anticoagulant parameter.

Indications for Use

Indicated for use in clinical laboratories as an automated coagulation analyzer for performing various coagulation assays including APTT, Antithrombin IIIa, Batroxobin, D-dimer, Deficient Plasmas, Derived Fibrinogen, 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 (K964139)

Submission Summary (Full Text)

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Dade Behring Inc. BCT™ System 510(k)-Modification

# AUG - 9 2001

## 510(k) Summary for BCT™ 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: _ HOII l 665

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

Manufacturer:

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

Contact Information:

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

Preparation date:

May 29, 2001

#### Device Name/ Classification: 2.

BCT™ System:

Multipurpose system for in vitro Coagulation studies

Classification Number:

Class II (864.5425)

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

BCT™ System [K955278, K001064, K001067]

#### Device Description: 4.

The current BCT™ System was originally determined to be substantially equivalent as a THE Garrent DO - Oycletir . coagulation analyzer in 510(k) Premarket Notification K955278. Subsequent to its clearance, the indications for use of the instrument were സംഖ് 6. Gubooquon: : : Premarket Notifications, K001064 and K001067 for the addition of various analytes. The current BCT™ System was cleared to perform coagulometric, of various unarytos: "The ochemical tests, such as the routine tests: prothrombin 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. The inclusion of the new testing parameter, lupus anticoagulants (LA), is the subject of this modification. The addition of the new proposed analyte to the instrument was accomplished without modification to the instrument principle, operation, hardware or instruction manual.

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#### Device Intended Use: 5.

Device Intendoul OOO!
The Behring Coagulation Timer Analyzer (BCT™) System is an automated blood plasma coagulation analyzer for in vitro diagnostic use.

- Medical device to which equivalence is claimed and comparison information: 6. The BCT™ System is substantially equivalent in intended use and results obtained to the The DOT - Oyetom le subject of 510(k) K964139. Both instruments Systhex - OF 8000 Oyelengths for the measurement of several coagulation assays.
### Device Performance Characteristics: 7.

### Correlation:

Correlation:
The modified BCT™ System comparison study evaluated plasma samples on the BCT™ rne modifiou Do - - System LA 2 Reagents versus Dade Behring LA 1 and LA 2 Reagents on the Sysmex® CA-6000 System.

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

| Assay | Sample<br>Number (n) | Coefficient of<br>Correlation (r) | Regression<br>Equation |
|----------------------------------------|----------------------|-----------------------------------|------------------------|
| LA 1 Screening Reagent (seconds) | 207 | 0.968 | y=0.87x + 4.34 |
| LA 2 Confirmation Reagent (seconds) | 208 | 0.882 | y=0.76x + 5.46 |
| LA 1/LA 2 Ratio | 206 | 0.965 | y=1.08x + 0.05 |
| LA 1 Screening Reagent (normalized) | 207 | 0.969 | y=0.89x + 0.11 |
| LA 2 Confirmation Reagent (normalized) | 208 | 0.882 | y=0.84x + 0.15 |
| LA 1/LA 2 Ratio (normalized) | 206 | 0.964 | y=0.97x + 0.04 |

### Precision:

Frecision.
Precision studies were performed by the evaluation of three levels of control material in a manner consistent with NCCLS Guideline EP5-A.

### Summary of Precision Studies

| Assay | Sample | Total Mean | Run-to-Run (%CV) | Within-Run (%CV) | Total (%CV) |
|-------------------------------------|------------------|------------|------------------|------------------|-------------|
| LA 1 Screening Reagent (seconds) | LA Control High | 71.92 | 1.6 | 1.3 | 2.0 |
| | LA Control Low | 51.23 | 1.7 | 1.4 | 2.2 |
| | Control Plasma N | 34.85 | 0.9 | 0.6 | 1.0 |
| LA 2 Confirmation Reagent (seconds) | LA Control High | 37.80 | 1.0 | 0.5 | 1.1 |
| | LA Control Low | 35.42 | 1.4 | 0.9 | 1.6 |
| | Control Plasma N | 36.59 | 1.7 | 0.8 | 1.9 |
| LA 1/LA 2 Ratio | LA Control High | 1.90 | 0.9 | 1.2 | 1.4 |
| | LA Control Low | 1.45 | 1.1 | 0.7 | 1.3 |
| | Control Plasma N | 0.95 | 0.9 | 0.9 | 1.2 |

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Rebecca S. Ayash Director, Regulatory Affairs DADE BEHRING, INC. P.O. Box 6101 Newark, Delaware 19714

AUG - 9 2001

Re: K011665 Trade Name: BCTTM System Regulation Number: 21 CFR § 864.5425 Regulatory Class: II Product Code: JPA Dated: May 29, 2001 Received: May 30, 2001

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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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 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact 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 Manufacturers International and Consumer Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Autman

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 Rehrinn Inc. BCT" System 510(k)-Modification

## Indications Statement

BCT™ System Device Name:

## Indications for Use:

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

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

Josephine Bautista

inical Laboratory Devices

510(k) Number K011665

(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)

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#### Device Intended Use: 5.

The Behring Coagulation Timer Analyzer (BCT™) System is an automated blood plasma coagulation analyzer for in vitro diagnostic use.

### Medical device to which equivalence is claimed and comparison information: 6.

The BCT™ System is substantially equivalent in intended use and results obtained to the Sysmex® CA-6000 System, which was the subject of 510(k) K964139. Both instruments use light at various wavelengths for the measurement of several coagulation assays.

#### Device Performance Characteristics: 7.

### Correlation:

The modified BCT™ System comparison study evaluated plasma samples on the BCT™ System with Dade Behring LA 1 and LA 2 Reagents versus Dade Behring LA 1 and LA 2 Reagents on the Sysmex® CA-6000 System.

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

| Assay | Sample<br>Number (n) | Coefficient of<br>Correlation (r) | Regression<br>Equation |
|----------------------------------------|----------------------|-----------------------------------|------------------------|
| LA 1 Screening Reagent (seconds) | 207 | 0.968 | y=0.87x + 4.34 |
| LA 2 Confirmation Reagent (seconds) | 208 | 0.882 | y=0.76x + 5.46 |
| LA 1/LA 2 Ratio | 206 | 0.965 | y=1.08x + 0.05 |
| LA 1 Screening Reagent (normalized) | 207 | 0.969 | y=0.89x + 0.11 |
| LA 2 Confirmation Reagent (normalized) | 208 | 0.882 | y=0.84x + 0.15 |
| LA 1/LA 2 Ratio (normalized) | 206 | 0.964 | y=0.97x + 0.04 |

### Precision:

Precision studies were performed by the evaluation of three levels of control material in a manner consistent with NCCLS Guideline EP5-A.

### Summary of Precision Studies

| Assay | Sample | Total<br>Mean | Run-to-<br>Run<br>(%CV) | Within-Run<br>(%CV) | Total<br>(%CV) |
|-------------------------------------|------------------|---------------|-------------------------|---------------------|----------------|
| LA 1 Screening Reagent (seconds) | LA Control High | 71.92 | 1.6 | 1.3 | 2.0 |
| LA 1 Screening Reagent (seconds) | LA Control Low | 51.23 | 1.7 | 1.4 | 2.2 |
| LA 1 Screening Reagent (seconds) | Control Plasma N | 34.85 | 0.9 | 0.6 | 1.0 |
| LA 2 Confirmation Reagent (seconds) | LA Control High | 37.80 | 1.0 | 0.5 | 1.1 |
| LA 2 Confirmation Reagent (seconds) | LA Control Low | 35.42 | 1.4 | 0.9 | 1.6 |
| LA 2 Confirmation Reagent (seconds) | Control Plasma N | 36.59 | 1.7 | 0.8 | 1.9 |
| LA 1/LA 2 Ratio | LA Control High | 1.90 | 0.9 | 1.2 | 1.4 |
| LA 1/LA 2 Ratio | LA Control Low | 1.45 | 1.1 | 0.7 | 1.3 |
| LA 1/LA 2 Ratio | Control Plasma N | 0.95 | 0.9 | 0.9 | 1.2 |