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

Device Description

The current BCT™ System was originally determined to be substantially equivalent as a coagulation analyzer in 510(k) Premarket Notification K955278. Subsequent to its clearance, the indications for use of the instrument were expanded through two additional Premarket Notifications, K001064 and K001067 for the addition of various analytes. The current BCT™ System was cleared to perform coagulometric, and chromogenic 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.

AI/ML Overview

This document describes the modification of the Dade Behring BCT™ System to include the new testing parameter, lupus anticoagulants (LA). The study demonstrates that the modified BCT™ system is substantially equivalent to the Sysmex® CA-6000 System for measuring Lupus Anticoagulants.

1. Table of Acceptance Criteria and Reported Device Performance:

The acceptance criteria for this 510(k) modification are based on demonstrating substantial equivalence to a predicate device (Sysmex® CA-6000 System) through correlation and precision studies. While explicit numerical acceptance criteria (e.g., minimum correlation coefficient) are not stated, the reported performance data is presented to show strong correlation, suggesting the device meets internal benchmarks for equivalence.

Correlation Study (Method Comparison):

Assay	Acceptance Criteria (Implied: Strong Correlation to Predicate)	Reported Performance (Coefficient of Correlation (r))	Regression Equation
LA 1 Screening Reagent (seconds)	R-value close to 1.0	0.968	y=0.87x + 4.34
LA 2 Confirmation Reagent (seconds)	R-value close to 1.0	0.882	y=0.76x + 5.46
LA 1/LA 2 Ratio	R-value close to 1.0	0.965	y=1.08x + 0.05
LA 1 Screening Reagent (normalized)	R-value close to 1.0	0.969	y=0.89x + 0.11
LA 2 Confirmation Reagent (normalized)	R-value close to 1.0	0.882	y=0.84x + 0.15
LA 1/LA 2 Ratio (normalized)	R-value close to 1.0	0.964	y=0.97x + 0.04

Precision Study (Implied Acceptance Criteria for %CV based on typical industry standards for coagulation assays):

Assay	Sample	Acceptance Criteria (Implied: Low %CV)	Reported Performance (Total %CV)
LA 1 Screening Reagent (seconds)	LA Control High	Typically < 5-10%	2.0
	LA Control Low	Typically < 5-10%	2.2
	Control Plasma N	Typically < 5-10%	1.0
LA 2 Confirmation Reagent (seconds)	LA Control High	Typically < 5-10%	1.1
	LA Control Low	Typically < 5-10%	1.6
	Control Plasma N	Typically < 5-10%	1.9
LA 1/LA 2 Ratio	LA Control High	Typically < 5-10%	1.4
	LA Control Low	Typically < 5-10%	1.3
	Control Plasma N	Typically < 5-10%	1.2

Study Conclusion: The consistently high correlation coefficients (most above 0.96, with the lowest being 0.882) and low coefficients of variation (all below 2.2%) demonstrate that the BCT™ System's performance for LA testing is comparable to the predicate device and exhibits good precision. This data supports the claim of substantial equivalence.

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

Sample Sizes:
- LA 1 Screening Reagent (seconds, normalized): 207 samples
- LA 2 Confirmation Reagent (seconds, normalized): 208 samples
- LA 1/LA 2 Ratio (normalized): 206 samples
Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It only states that the study "evaluated plasma samples."

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

This study is a method comparison and precision study for a diagnostic instrument's analytical performance, not a study involving diagnostic image interpretation or complex clinical decision-making by human experts. Therefore, the concept of "experts establishing ground truth" in the traditional sense (e.g., radiologists, pathologists) is not directly applicable.
The "ground truth" or reference method for the method comparison study is the Sysmex® CA-6000 System using Dade Behring LA 1 and LA 2 Reagents.
For the precision study, the "ground truth" is established by the known values of the control materials used.

4. Adjudication Method for the Test Set:

Not applicable as this is an analytical performance study comparing instrument measurements, not a study requiring human adjudication of diagnostic findings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve With AI vs Without AI Assistance:

Not applicable. This is not an MRMC study and does not involve human readers or AI assistance in diagnostic interpretation. It is a comparison of two automated coagulation analyzers.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Yes, this study represents the standalone performance of the BCT™ System for measuring Lupus Anticoagulants. The data presented is the direct output of the instrument's analytical capabilities compared to a predicate device and control materials.

7. The Type of Ground Truth Used:

Method Comparison Study: The ground truth is the measurements obtained from the predicate device, the Sysmex® CA-6000 System, which is a legally marketed device already established for these specific coagulation assays.
Precision Study: The ground truth is the assigned values of the control materials (LA Control High, LA Control Low, Control Plasma N).

8. The Sample Size for the Training Set:

The document does not mention a "training set" as this is a traditional analytical validation study for a medical device, not a machine learning or AI algorithm development study. The instrument's method for measuring LA is established, and this study validates its performance.

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

Not applicable, as there is no "training set" in the context of this type of analytical device validation. The "ground truth" for the performance evaluation (test set) is described in point 7.

Summary

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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	SampleNumber (n)	Coefficient ofCorrelation (r)	RegressionEquation
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 (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" (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 (800) 638-2041 or (301) 443-6597 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	SampleNumber (n)	Coefficient ofCorrelation (r)	RegressionEquation
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	TotalMean	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 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

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.