The intended use of the Sysmex® CA-7000 is as a fully automated, computerized blood plasma coagulation analyzer for in vitro diagnostic use in clinical laboratories. The instrument uses citrated human plasma to perform coagulation tests.

Device Description

Not Found

AI/ML Overview

The Sysmex® Automated Coagulation Analyzer CA-7000 performed a clinical correlation study and a precision study to demonstrate its performance claims as being similar to predicate devices.

1. Table of acceptance criteria and the reported device performance:

The document describes two types of studies: "Summary of Method Comparison Studies Between CA-6000 or BCS" and "Summary of Precision Studies Sysmex® Automated Coagulation Analyzer CA-7000".

Acceptance Criteria for Method Comparison Studies (Implied via Predicate Equivalence):
The acceptance criteria for the method comparison studies are implicitly defined by demonstrating substantial equivalence to the predicate devices (Sysmex® Automated Coagulation Analyzer CA-6000 and Behring Coagulation System (BCS™ System)). This is primarily evaluated through the Coefficient of Correlation (r), which should be close to 1 (indicating a strong positive linear relationship), and visual inspection of the Regression Equation.

Reported Device Performance (Method Comparison Studies):

Test	Predicate Device	Sample Number (n)	Coefficient of Correlation (r)	Regression Equation
Prothrombin Time (Innovin®, seconds)	CA-6000	155	0.999	Y = 0.97X + 0.38
Prothrombin Time (Innovin®, INR)	CA-6000	155	0.999	Y = 0.95X + 0.04
Prothrombin Time (Thromborel® S, seconds)	BCS	174	0.997	Y = 1.09X - 1.54
Prothrombin Time (Thromborel® S, % PT)	BCS	168	0.984	Y = 0.98X - 3.40
Derived Fibrinogen	CA-6000	104	0.991	Y = 1.02X + 0.12
Activated Partial Thromboplastin Time	CA-6000	151	0.997	Y = 1.03X - 0.01
Fibrinogen (Clauss)	CA-6000	134	0.994	Y = 0.91X + 0.05
Factor VII	BCS	124	0.993	Y = 1.14X - 2.66
Factor VIII	BCS	143	0.977	Y = 1.10X - 4.46
Protein C, coagulometric	BCS	139	0.994	Y = 1.14X - 4.77
Thrombin Time	CA-6000	381	0.981	Y = 0.78X + 2.72
Batroxobin Time	BCS	169	0.987	Y = 1.02X + 0.75
Lupus Anticoagulant LA1 Screening Reagent	CA-6000	136	0.996	Y = 0.92X - 1.25
Lupus Anticoagulant LA2 Confirmation Reagent	CA-6000	136	0.953	Y = 0.66X + 10.59
Lupus Anticoagulant LA1/LA2 Ratio	CA-6000	136	0.987	Y = 1.00X - 0.08
Antithrombin III	BCS	166	0.997	Y = 0.96X - 1.07
Heparin, chromogenic	BCS	115	0.982	Y = 1.02X + 0.01
Plasminogen, chromogenic	BCS	142	0.994	Y = 0.96X + 0.55
a2- Antiplasmin, chromogenic	BCS	144	0.982	Y = 0.95X + 3.18
Protein C, chromogenic	BCS	156	0.996	Y = 0.98X - 0.63
Factor VIII, chromogenic	BCS	136	0.990	Y = 1.10X - 1.52

Acceptance Criteria for Precision Studies:
The acceptance criteria for precision are not explicitly stated as numerical thresholds (e.g., maximum allowable %CV). However, the intent is to demonstrate acceptable within-run, between-run, and total precision for each assay at different control levels. The reported %CV values should be within generally accepted clinical laboratory standards for these types of assays.

Reported Device Performance (Precision Studies):

Assay / Control Level	n	Mean	Within Run %CV	Between Run %CV	Total %CV
Prothrombin Time (Innovin®, seconds)
Control Plasma N	40	11.9	0.4	0.2	0.4
Ci-Trol® Control Level 3	40	37.2	0.5	2.0	2.1
Prothrombin Time (Innovin®, INR)
Control Plasma N	40	1.1	0.4	0.2	0.4
Ci-Trol® Control Level 3	40	3.4	0.5	2.1	2.1
Prothrombin Time (Thromborel®S, seconds)
Control Plasma N	40	12.0	0.4	0.5	0.6
Control Plasma P	40	25.1	0.9	1.1	1.4
Prothrombin Time (Thromborel®S, % of norm)
Control Plasma N	40	91.9	0.6	0.6	0.8
Control Plasma P	40	36.1	1.0	1.2	1.5
Derived Fibrinogen (Innovin®, g/L)
Control Plasma N	40	1.9	5.4	2.2	5.5
Path. plasmapool	40	5.7	3.2	1.3	3.3
Activated Partial Thromboplastin Time (Actin® FSL, seconds)
Control Plasma N	40	29.6	0.7	0.3	0.7
Ci-Trol® Control Level 3	40	70.4	0.6	0.4	0.7
Fibrinogen (Clauss) (Thrombin, g/L)
Control Plasma N	40	2.5	1.4	0.7	1.5
Control Plasma P	40	0.9	2.5	1.2	2.6
Factor VII (Innovin®)
Control Plasma N	40	99.7	2.4	3.4	4.1
Control Plasma P	40	31.5	1.7	2.4	2.8
Factor VIII (Actin® FSL)
Control Plasma N	40	104.6	6.5	5.2	8.1
Control Plasma P	40	33.8	5.9	3.9	6.8
Protein C Coagulometric (Protein C Reagent, % norm)
Control Plasma N	40	112.5	3.2	1.2	3.2
Control Plasma P	40	40.9	4.3	2.4	4.6
Thrombin Time (Test Thrombin Reagent, seconds)
Control Plasma N	40	16.5	0.6	1.1	1.3
Path. plasmapool	40	19.7	3.5	4.4	5.5
Batroxobin Time (Batroxobin Reagent, seconds)
Control Plasma N	40	20.1	1.1	0.6	1.2
Path. plasmapool	40	58.3	1.2	0.7	1.4
Lupus Anticoagulant (LA1 Screening, seconds)
Control Plasma N	40	36.1	1.6	2.7	3.1
LA Control High	40	90.6	1.5	1.5	2.1
Lupus Anticoagulant (LA2 Confirmation, seconds)
Control Plasma N	40	34.6	1.0	0.4	1.0
LA Control High	40	40.4	1.0	0.9	1.3
Lupus Anticoagulant (LA1 / LA2, ratio)
Control Plasma N	40	1.04	1.0	2.5	2.7
LA Control High	40	2.24	1.2	0.9	1.5
Antithrombin III (Berichrom™ Antithrombin III (A))
Control Plasma N	40	92.6	1.6	0.7	1.7
Control Plasma P	40	31.7	1.8	0.7	1.9
Heparin (Berichrom™ Heparin Reagent)
Ci-Trol® Heparin Control Low	40	0.06	7.3	6.1	9.2
Ci-Trol® Heparin Control High	40	0.22	1.9	2.1	2.8
Plasminogen (Berichrom™ Plasminogen Reagent, % norm)
Control Plasma N	40	101.4	1.2	1.4	1.8
Control Plasma P	40	34.6	1.3	2.5	2.8
α2-Antiplasmin (Berichrom™ α2-Antiplasmin, % norm)
Control Plasma N	40	98.8	1.5	0.9	1.7
Control Plasma P	40	35.4	3.2	1.8	3.5
Protein C (Berichrom™ Protein C Reagent, % norm)
Control Plasma N	40	101.9	1.7	0.8	1.8
Control Plasma P	40	33.3	2.7	2.4	3.5
Factor VIII Chromogenic (% norm)
Control Plasma N	40	107.5	1.7	3.8	4.2
Control Plasma P	40	29.6	1.4	2.4	2.8

2. Sample sizes used for the test set and the data provenance:

Sample Size for Test Set (Clinical Correlation Studies):
- The sample sizes varied by assay, ranging from 104 (Derived Fibrinogen) to 381 (Thrombin Time). All specific sample sizes are listed in the table above under "Sample Number (n)".
Data Provenance:
- The document states: "During those studies, specimens were evaluated from apparently healthy individuals and from patients with different pathological conditions which are expected to affect the results for a particular assay." This suggests a mix of prospective and retrospective samples, likely collected to represent a clinically relevant range.
- There is no explicit mention of the country of origin for the clinical data. The manufacturing site is Sysmex Corporation, Kobe, Japan, and the distributor is Dade Behring Inc. in the US, but this does not specify the origin of the clinical samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The study compares the new device's readings against predicate devices, implying that the predicate devices' results serve as the reference or "ground truth" for the comparison. There is no mention of independent experts establishing a ground truth for the clinical correlation studies.

4. Adjudication method for the test set:

This information is not applicable as the ground truth was established by comparing to predicate devices, not by expert consensus requiring adjudication.

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:

This information is not applicable. The device is an automated coagulation analyzer, which does not involve "human readers" or "AI assistance" in the context of interpreting medical images or data by human clinicians. It is a laboratory instrument that outputs numerical results.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Yes, the entire study focuses on the standalone performance of the Sysmex® Automated Coagulation Analyzer CA-7000. It is an automated system designed to operate "without human-in-the-loop performance" for the actual coagulation test execution and measurement. The results are generated directly by the analyzer.

7. The type of ground truth used:

The "ground truth" for the method comparison studies was the results obtained from the predicate devices (Sysmex® Automated Coagulation Analyzer CA-6000 or Behring Coagulation System (BCS™ System)). This is a form of comparative (or reference method) ground truth where an established, cleared device's performance serves as the benchmark.
For precision studies, the concept of "ground truth" is different; it's about the device's internal consistency and reproducibility, which is assessed inherently by statistical analysis of repeated measurements on control samples.

8. The sample size for the training set:

This information is not applicable. This device is a traditional laboratory instrument, not an AI/machine learning model that typically requires a "training set" in the common sense of AI development. It operates based on established chemical and optical principles.

9. How the ground truth for the training set was established:

This information is not applicable for the same reasons as #8.

Summary

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16 2099

510(k) Summary of Safety and Effectiveness Information Sysmex® Automated Coagulation Analyzer CA-7000 March 26, 2002

Dade Behring Inc. 13251 NW 9th Terrace Miami, FL 33182 Contact Person: Radames Riesgo at 305.480.7558 or by facsimile at 305.552.5288

JUN 2 7 2002

Trade or Proprietary Name: Sysmex® Automated Coagulation Analyzer CA-7000
----------------------------------------------------------------------------	--	--	--	--	--

Common or Usual Name:	Automated Coagulation System
Classification Name:	Coagulation Instrument (21 CFR §864.5400)
Registration Number:
	Manufacturing SiteSysmex CorporationKobe, Japan	9613959
	ImporterSysmex Corporation of AmericaOne Wildlife WayLong Grove, IL 60047-9596	1422681
	DistributerDade Behring Inc.Glasgow SiteP.O. Box 6101Newark, DE 19714-6101	2517506

The CA-7000 is substantially equivalent in intend use and technological characteristics to the Sysmex® Automated Coagulation Analyzer CA-6000, Sysmex Corporation, Kobe, Japan, which was cleared by FDA under Document Control Nos. K964139, K992321, K993174 and K001145; or the Behring Coagulation System (BCS™ System), Dade Behring, Marburg, Germany, which was cleared by FDA under Document Control Nos. K970431 and K000973.

As demonstrated by clinical correlation studies, the performance claims of the proposed device are similar to the predicate devices. During those studies, specimens were evaluated from apparently healthy individuals and from patients with different pathological conditions which are expected to affect the results for a particular assay. The following summaries show the results of the comparison studies between the proposed and the predicate devices as well as the results of of the precision studies performed with the CA-7000 analyzer.

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Test	PredicateDevice	SampleNumber(n)	Coefficient ofCorrelation(r)	RegressionEquitation
Prothrombin Time(Innovin®, seconds)	CA-6000	155	0.999	Y = 0.97X + 0.38
Prothrombin Time(Innovin®, INR)	CA-6000	155	0.999	Y = 0.95X + 0.04
Prothrombin Time(Thromborel® S, seconds)	BCS	174	0.997	Y = 1.09X - 1.54
Prothrombin Time(Thromborel® S, % PT)	BCS	168	0.984	Y = 0.98X - 3.40
Derived Fibrinogen	CA-6000	104	0.991	Y = 1.02X + 0.12
Activated PartialThromboplastin Time	CA-6000	151	0.997	Y = 1.03X - 0.01
Fibrinogen (Clauss)	CA-6000	134	0.994	Y = 0.91X + 0.05
Factor VII	BCS	124	0.993	Y = 1.14X - 2.66
Factor VIII	BCS	143	0.977	Y = 1.10X - 4.46
Protein C, coagulometric	BCS	139	0.994	Y = 1.14X - 4.77
Thrombin Time	CA-6000	381	0.981	Y = 0.78X + 2.72
Batroxobin Time	BCS	169	0.987	Y = 1.02X + 0.75
Lupus AnticoagulantLA1 Screening Reagent	CA-6000	136	0.996	Y = 0.92X - 1.25
Lupus AnticoagulantLA2 Confirmation Reagent	CA-6000	136	0.953	Y = 0.66X + 10.59
Lupus AnticoagulantLA1/LA2 Ratio	CA-6000	136	0.987	Y = 1.00X - 0.08
Antithrombin III	BCS	166	0.997	Y = 0.96X - 1.07
Heparin, chromogenic	BCS	115	0.982	Y = 1.02X + 0.01
Plasminogen, chromogenic	BCS	142	0.994	Y = 0.96X + 0.55
a2- Antiplasmin,chromogenic	BCS	144	0.982	Y = 0.95X + 3.18
Protein C, chromogenic	BCS	156	0.996	Y = 0.98X - 0.63
Factor VIII, chromogenic	BCS	136	0.990	Y = 1.10X - 1.52

Summary of Method Comparison Studies Between CA-6000 or BCS

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Assay	Control Level	n	mean	WithinRun%CV	BetweenRun%CV	Total%CV
Prothrombin Time	Control Plasma N	40	11.9	0.4	0.2	0.4
(Dade® Innovin® Reagent, seconds)	Ci-Trol®Control Level3	40	37.2	0.5	2.0	2.1
Prothrombin Time	Control Plasma N	40	1.1	0.4	0.2	0.4
(Dade® Innovin® Reagent, INR)	Ci-Trol®Control Level3	40	3.4	0.5	2.1	2.1
Prothrombin Time	Control Plasma N	40	12.0	0.4	0.5	0.6
(Thromborel®S Reagent, seconds)	Control Plasma P	40	25.1	0.9	1.1	1.4
Prothrombin Time	Control Plasma N	40	91.9	0.6	0.6	0.8
(Thromborel®S Reagent, % of norm)	Control Plasma P	40	36.1	1.0	1.2	1.5
Derived Fibrinogen	Control Plasma N	40	1.9	5.4	2.2	5.5
(Dade® Innovin® Reagent, g/L)	Path. plasmapool	40	5.7	3.2	1.3	3.3
Activated Partial Thromboplastin Time	Control Plasma N	40	29.6	0.7	0.3	0.7
(Dade® Actin® FSL Reagent, seconds)	Ci-Trol®Control Level3	40	70.4	0.6	0.4	0.7
Fibrinogen (Clauss)	Control Plasma N	40	2.5	1.4	0.7	1.5
(Dade® Thrombin Reagent, g/L)	Control Plasma P	40	0.9	2.5	1.2	2.6
Factor VII	Control Plasma N	40	99.7	2.4	3.4	4.1
(Dade® Innovin® Reagent)	Control Plasma P	40	31.5	1.7	2.4	2.8
Factor VIII	Control Plasma N	40	104.6	6.5	5.2	8.1
(Dade® Actin® FSL Reagent)	Control Plasma P	40	33.8	5.9	3.9	6.8
Protein C Coagulometric	Control Plasma N	40	112.5	3.2	1.2	3.2
(Portein C Reagent, % of norm)	Control Plasma P	40	40.9	4.3	2.4	4.6
Thrombin Time	Control Plasma N	40	16.5	0.6	1.1	1.3
(Test Thrombin Reagent, seconds)	Path. plasmapool	40	19.7	3.5	4.4	5.5
Assay	Control Level	n	Mean	WithinRun%CV	BetweenRun%CV	Total%CV
Batroxobin Time(Batroxobin Reagent, seconds)	Control Plasma NPath. plasmapool	4040	20.158.3	1.11.2	0.60.7	1.21.4
Lupus Anticoagulant(LA1 Screening Reagent)(seconds)	Control Plasma NLA Control High	4040	36.190.6	1.61.5	2.71.5	3.12.1
Lupus Anticoagulant(LA2 Confirmation Reagent)(seconds)	Control Plasma NLA Control High	4040	34.640.4	1.01.0	0.40.9	1.01.3
Lupus Anticoagulant(LA1 / LA2)(ratio)	Control Plasma NLA Control High	4040	1.042.24	1.01.2	2.50.9	2.71.5
Antithrombin III(Berichrom™ Antithrombin III (A)Reagent)	Control Plasma NControl Plasma P	4040	92.631.7	1.61.8	0.70.7	1.71.9
Heparin(Berichrom™ Heparin Reagent)	Ci-Trol®HeparinControl LowCi-Trol®HeparinControl High	4040	0.060.22	7.31.9	6.12.1	9.22.8
Plasminogen(Berichrom™ Plasminogen Reagent)(% of norm)	Control Plasma NControl Plasma P	4040	101.434.6	1.21.3	1.42.5	1.82.8
α2-Antiplasmin(Berichrom™ α2-AntiplasminReagent)(% of norm)	Control Plasma NControl Plasma P	4040	98.835.4	1.53.2	0.91.8	1.73.5
Protein C,(Berichrom™ Protein C Reagent)(% of norm)	Control Plasma NControl Plasma P	4040	101.933.3	1.72.7	0.82.4	1.83.5
Factor VIII Chromogenic(Factor VIII Chromogenic Assay)(% of norm)	Control Plasma NControl Plasma P	4040	107.529.6	1.71.4	3.82.4	4.22.8

Summary of Precision Studies Sysmex® Automated Coagulation Analyzer CA-7000

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Summary of Precision Studies (Continued) Sysmex® Automated Coagulation Analyzer CA-7000

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Image /page/4/Picture/1 description: The image is a seal for the Department of Health & Human Services USA. The seal features the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around a symbol. The symbol is a stylized representation of three human profiles facing right, with flowing lines suggesting movement or connection.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 2 7 2002

Mr. Radames Riesgo Manager, Regulatory Affairs and Compliance Dade Behring Inc. Glasgow Site P.O. Box 6101 Newark, DE 19714-6101

Re: K020979

Trade/Device Name: Sysmex® Automated Coagulation Analyzer CA-7000 Regulation Number: 21 CFR 864.5400 Regulation Name: Coagulation Instrument Regulatory Class: Class II Product Code: GKP Dated: June 21, 2002 Received: June 24, 2002

Dear Mr. Riesgo:

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 (OS) 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 1 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/dsmaldsmamain.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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510(k) Number (if known): _ K O&O 979

Device Name: Sysmex® Automated Coagulation Analyzer CA-7000

Indications for Use:

The intended use of the Sysmex® CA-7000 is as a fully automated, computerized blood plasma coagulation analyzer for in vitro diagnostic use in clinical laboratories.

The instrument uses citrated human plasma to perform coagulation tests.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Josephine Bautista

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

Prescription Use (Per 21 CFR 801.109)

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

Regulation Number and Section

§ 864.5400 Coagulation instrument.

(a)
Identification. A coagulation instrument is an automated or semiautomated device used to determine the onset of clot formation for in vitro coagulation studies.(b)
Classification. Class II (special controls). A fibrometer or coagulation timer intended for use with a coagulation instrument is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.