The intended use of the Sysmex® CA-500 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 the following parameters and calculated parameters:

Clotting Analysis Parameters

Prothrombin Time (PT) ●
Activated Partial Thromboplastin Time (APTT) .
Fibrinogen (Clauss) .

Chromogenic Analysis Parameters

Antithrombin III ●
Protein C t

Calculated Parameters

PT Ratio .
PT INR ●
Batroxobin .
Protein C ●
Heparin .
Derived Fibrinogen .

Device Description

The Sysmex® CA-500 is intended for use as an automated citrated human plasma coagulation analyzer.

AI/ML Overview

{
  "acceptance_criteria_and_study": {
    "1._table_of_acceptance_criteria_and_reported_device_performance": {
      "Method Comparison Studies": {
        "Predicate Device": "Behring Coagulation Timer (BCT) or Behring Fibrintimer A (BFA)",
        "Acceptance Criteria (Implicit)": "Coefficient of Correlation (r) > 0.95 for method comparison to predicate device",
        "Reported Device Performance": {
          "Batroxobin (vs. BCT)": "r = 0.984",
          "Protein C, Chromogenic (vs. BCT)": "r = 0.963",
          "Heparin, Chromogenic (vs. BCT)": "r = 0.977",
          "Protein C, Coagulometric (vs. BFA)": "r = 0.974"
        }
      },
      "Precision Studies": {
        "Acceptance Criteria (Implicit)": "Low %CV (Coefficient of Variation) for within-run, between-run, and total precision.",
        "Reported Device Performance": {
          "Batroxobin Time (CPN)": "Within-Run %CV = 1.0, Between-Run %CV = 1.2, Total %CV = 1.5",
          "Batroxobin Time (Pool Plasma 2)": "Within-Run %CV = 1.9, Between-Run %CV = 0.7, Total %CV = 1.9",
          "Protein C Coagulometric (CPN)": "Within-Run %CV = 4.8, Between-Run %CV = 3.6, Total %CV = 5.8",
          "Protein C Coagulometric (CPP)": "Within-Run %CV = 9.0, Between-Run %CV = 6.2, Total %CV = 10.4",
          "Protein C Chromogenic (CPN)": "Within-Run %CV = 1.6, Between-Run %CV = 1.0, Total %CV = 1.8",
          "Protein C Chromogenic (CPP)": "Within-Run %CV = 3.6, Between-Run %CV = 1.4, Total %CV = 3.6",
          "Heparin (Ci-Trol Hep Hi)": "Within-Run %CV = 4.0, Between-Run %CV = 5.2, Total %CV = 6.4",
          "Heparin (Ci-Trol Hep Lo)": "Within-Run %CV = 5.6, Between-Run %CV = 4.7, Total %CV = 7.1"
        }
      }
    },
    "2._sample_size_used_for_the_test_set_and_the_data_provenance": {
      "Method Comparison Studies": {
        "Batroxobin": "183 samples",
        "Protein C, Chromogenic": "114 samples",
        "Heparin, Chromogenic": "53 samples",
        "Protein C, Coagulometric": "Not explicitly stated for BFA comparison, but implied to be similar numbers for other tests (e.g., 114 range for Protein C tests with BCT)",
        "Data Provenance": "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. Country of origin not specified, but likely within Dade Behring's operational regions (e.g., USA, Europe). Retrospective or prospective not specified, but typically prospective for method comparison studies."
      },
      "Precision Studies": {
        "Batroxobin Time (CPN/Pool Plasma 2)": "40 samples per level",
        "Protein C Coagulometric (CPN/CPP)": "40 samples per level",
        "Protein C Chromogenic (CPN/CPP)": "40 samples per level",
        "Heparin (Ci-Trol Hep Hi/Lo)": "32 samples per level",
        "Data Provenance": "Control materials (CPN, CPP, Ci-Trol Hep Hi/Lo) and pooled plasma. Country of origin not specified. Prospective testing."
      }
    },
    "3._number_of_experts_used_to_establish_the_ground_truth_for_the_test_set_and_the_qualifications_of_those_experts": "Not applicable. This device is an automated coagulation analyzer, and its performance is evaluated against established laboratory methods (predicate devices) and internal quality control samples, not against expert human interpretation of clinical data or images.",
    "4._adjudication_method_for_the_test_set": "Not applicable. Ground truth for performance studies of automated laboratory analyzers is typically established by the results from a legally marketed predicate device or by standard reference materials, not through expert 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": "Not applicable. This is an automated laboratory analyzer, not an AI-assisted diagnostic imaging or interpretation device that would involve human readers.",
    "6._if_a_standalone_(i.e._algorithm_only_without_human-in-the-loop_performance)_was_done": "Yes. The studies presented (method comparison and precision) evaluate the standalone performance of the Sysmex® Automated Coagulation Analyzer CA-500 against predicate devices and internal controls. There is no human-in-the-loop component for the analytical performance itself.",
    "7._the_type_of_ground_truth_used": "The ground truth for the test set (method comparison) was established by the measurements obtained from legally marketed predicate devices (Behring Coagulation Timer (BCT) and Behring Fibrintimer A (BFA)). For precision studies, it was based on the expected values of control materials and pooled plasmas.",
    "8._the_sample_size_for_the_training_set": "Not applicable. This is an automated laboratory analyzer, not a machine learning or AI-based device that typically requires a 'training set'. Its operational parameters are likely calibrated during manufacturing and validated through performance testing.",
    "9._how_the_ground_truth_for_the_training_set_was_established": "Not applicable for the same reasons as above. The device's internal algorithms are based on established coagulation measurement principles, not learned from a training dataset."
  }
}

Summary

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SEP 2 1 1999

510(k) Summary of Safety and Effectiveness Information Sysmex ® Automated Coagulation Analyzer CA-500 July 20, 1999

Dade Behring Inc. 1851 Delaware Parkway Miami, FL 33125 Contact Person: Radames Riesgo at 305.636.7727 or by facsimile at 305.637.6887.

Trade or Proprietary Name:	Sysmex® Automated Coagulation Analyzer CA-500
Common or Usual Name:	Automated Coagulation Instruments
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
	DistributorDade Behring Inc.Glasgow SiteP.O. Box 6101Newark, DE 19714-6101	2517506

The Sysmex® CA-500 is substantially equivalent in intended use to the Behring Coagulation Timer (BCT), which was previously cleared under Document Control No. K955278; or to the Behring Fibrintimer A (BFA), which was previously cleared under Document Control Nos. K924124 and K926551. The Sysmex® CA-500 is intended for use as an automated citrated human plasma coagulation analyzer.

{1}------------------------------------------------

510(k) Summary of Safety and Effectiveness Information Sysmex® Automated Coagulation Analyzer CA-500 Attachment 4, Page 2

As demonstrated by in-house correlation studies, the performance claims of the proposed device are similar to the predicate device. 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 summary shows the results of the comparison studies between the proposed and the predicate devices.

Summary of Method Comparison Studies between CA-500 and BCT

Test	SampleNumber(n)	Coefficient ofCorrelation(r)	RegressionEquation
Batroxobin	183	0.984	Y = 0.77X + 5.66
Protein C, Chromogenic	114	0.963	Y = 1.05X - 1.02
Heparin, Chromogenic	53	0.977	Y = 0.92X - 0.01

Summary of Method Comparison Studies between CA-500 and BFA

I est	11/1 37 1 12 12 12 12 12 12 12 12 12.	SampleNumber	Correlation	Coefficient of Regression &And and the mail of the mail of the mail of the mail of the mail of the mail of the mail of the mail of the mail of the states of the states of the states of the states of thCourtion
Protein C. Coagulometric			0.974	= = 1.02X -

Summary of Precision Studies Sysmex® Automated Coagulation Analyzer CA-500

Assay	Control Level	n	Mean	WithinRun %CV	BetweenRun %CV	Total%CV
Batroxobin Time	CPN	40	19.0	1.0	1.2	1.5
(Batroxobin Reagent, sec)	Pool Plasma 2	40	44.5	1.9	0.7	1.9
Protein C Coagulometric	CPN	40	94.4	4.8	3.6	5.8
(Protein C Reagent, Coagulometric, %)	CPP	40	33.5	9.0	6.2	10.4
Protein C Chromogenic	CPN	40	93.2	1.6	1.0	1.8
(Berichrom Protein C, %)	CPP	40	30.9	3.6	1.4	3.6
Heparin	Ci-Trol Hep Hi	32	0.4	4.0	5.2	6.4
(Berichrom Heparin, IU/ml)	Ci-Trol Hep Lo	32	0.2	5.6	4.7	7.1

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle.

SEP 2 1 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Radames Riesgo Manager, Regulatory Affairs Biology Dade Behring, Inc. 1851 Delaware Parkway Miami, Florida 33125

Re: K992423

Trade Name: Sysmex® Automated Coagulation Analyzer CA-500 Regulatory Class: II Product Code: GKP, JPA Dated: August 25, 1999 Received: August 26, 1999

Dear Mr. Riesgo:

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

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/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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K992423 510(k) Number (if known): _

Device Name: Sysmex® Automated Coagulation Analyzer CA-500

Indications For Use:

The intended use of the Sysmex® CA-500 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 the following parameters and calculated parameters:

Clotting Analysis Parameters

Prothrombin Time (PT) ●
Activated Partial Thromboplastin Time (APTT) .
Fibrinogen (Clauss) .

Chromogenic Analysis Parameters

Antithrombin III ●
Protein C t

Calculated Parameters

PT Ratio .
PT INR ●
Batroxobin .
Protein C ●
Heparin .
Derived Fibrinogen .

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Jha Khan
7/20/99

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

Prescription Use (Per 21 CFR 801.109) OR

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.