LogoFDA 510(k) Search
K Number
K993299
Device Name
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500
Manufacturer
DADE BEHRING, INC.
Date Cleared
1999-12-07

(67 days)

Product Code
GKP
Regulation Number
864.5400
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the Sysmex® CA-1500 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 . Calculated Parameters - . PT Ratio - PT INR - PT % ● - Extrinsic Factors (II, V, VII, X) ● Intrinsic Factors (VIII, IX, XI, XII) . - Derived Fibrinogen ● - Factor Assays % Activity .
Device Description
The CA-1500 is substantially equivalent in intended 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 and K992321; or the Behring Coagulation Timer (BCT), Dade Behring, Marburg, Germany which was cleared by FDA under Document Control No. K955278.
More Information

K964139, K992321, K955278

Not Found

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the device as a standard automated coagulation analyzer with performance studies based on correlation and precision metrics, not AI/ML model evaluation.

No.
This device is an in vitro diagnostic (IVD) device used for analyzing blood plasma coagulation, not for directly treating a medical condition.

Yes

The "Intended Use / Indications for Use" section explicitly states that the device is "for in vitro diagnostic use in clinical laboratories." It also lists various "Clotting Analysis Parameters" and "Chromogenic Analysis Parameters" that are used to analyze blood plasma coagulation, which are diagnostic tests.

No

The device is described as a "fully automated, computerized blood plasma coagulation analyzer" and the description of performance studies includes details about method comparison and precision studies, which are typical for hardware-based laboratory analyzers. The predicate devices are also described as "Automated Coagulation Analyzer" and "Coagulation Timer," further indicating a hardware component.

Yes, this device is an IVD (In Vitro Diagnostic).

The "Intended Use / Indications for Use" section explicitly states: "The intended use of the Sysmex® CA-1500 is as a fully automated, computerized blood plasma coagulation analyzer for in vitro diagnostic use in clinical laboratories."

N/A

Intended Use / Indications for Use

The intended use of the Sysmex® CA-1500 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 .
    Calculated Parameters
  • . PT Ratio
  • PT INR
  • PT % ●
  • Extrinsic Factors (II, V, VII, X) ● Intrinsic Factors (VIII, IX, XI, XII) .
  • Derived Fibrinogen ●
  • Factor Assays % Activity .

Product codes

GKP

Device Description

Not Found

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

clinical laboratories

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Clinical correlation studies were performed to demonstrate substantial equivalence to predicate devices.
Comparison studies between the proposed device (CA-1500) and predicate devices (CA-6000 or BCT) are summarized as follows:

  • Prothrombin Time (Innovin®, Seconds): CA-6000, n=165, r=0.999, Y = 0.97X + 0.09
  • Prothrombin Time (Innovin®, INR): CA-6000, n=165, r=0.999, Y = 0.99X + 0.01
  • Prothrombin Time (Thromborel® S, Seconds): BCT, n=163, r=0.998, Y = 1.04X - 0.51
  • Prothrombin Time (Thromborel® S, %): BCT, n=161, r=0.996, Y = 1.08X - 2.44
  • Derived Fibrinogen: BCT, n=149, r=0.945, Y = 1.17X - 0.54
  • Activated Partial Thromboplastin Time: CA-6000, n=128, r=0.995, Y = 1.00X + 0.15
  • Fibrinogen (Clauss): CA-6000, n=115, r=0.985, Y = 0.96X + 0.41
  • Factor VII: CA-6000, n=122, r=0.997, Y = 1.04X - 1.67
  • Factor VIII: CA-6000, n=66, r=0.990, Y = 0.96X + 4.25
  • Antithrombin III: BCT, n=104, r=0.998, Y = 0.97X - 4.72

Precision studies for Sysmex® Automated Coagulation Analyzer CA-1500:

  • Prothrombin Time (Dade® Innovin®, Seconds): CPN Level, N=40, Mean=11.5, Within Run %CV=0.4, Between Run %CV=0.5, Total %CV=0.6; Path. Pool, N=40, Mean=23.3, Within Run %CV=1.2, Between Run %CV=0.9, Total %CV=1.4
  • Prothrombin Time (Dade® Innovin®, INR): CPN Level, N=40, Mean=1.1, Within Run %CV=0.4, Between Run %CV=0.5, Total %CV=0.6; Path. Pool, N=40, Mean=2.2, Within Run %CV=1.2, Between Run %CV=0.9, Total %CV=1.4
  • Prothrombin Time (Thromborel® S, Seconds): CPN Level, N=40, Mean=11.8, Within Run %CV=0.6, Between Run %CV=2.0, Total %CV=2.1; Path. Pool, N=40, Mean=28.4, Within Run %CV=0.6, Between Run %CV=3.0, Total %CV=3.0
  • Prothrombin Time (Thromborel® S, %): CPN Level, N=40, Mean=95.0, Within Run %CV=0.9, Between Run %CV=3.4, Total %CV=3.6; Path. Pool, N=40, Mean=23.4, Within Run %CV=0.8, Between Run %CV=4.1, Total %CV=4.2
  • Derived Fibrinogen (Dade® Innovin® on CA-1500): CPN Level, N=40, Mean=1.8, Within Run %CV=3.7, Between Run %CV=3.2, Total %CV=4.7; Path. Pool, N=40, Mean=5.0, Within Run %CV=2.4, Between Run %CV=1.2, Total %CV=2.6
  • Activated Partial Thromboplastin Time (Dade® Actin® FSL): CPN Level, N=40, Mean=28.1, Within Run %CV=2.1, Between Run %CV=1.4, Total %CV=2.4; Path. Pool, N=40, Mean=39.5, Within Run %CV=0.5, Between Run %CV=1.9, Total %CV=2.0
  • Fibrinogen (Clauss) (Dade® Thrombin Reagent): CPN Level, N=40, Mean=2.7, Within Run %CV=1.9, Between Run %CV=2.7, Total %CV=3.2; CPP, N=40, Mean=0.7, Within Run %CV=8.4, Between Run %CV=4.9, Total %CV=9.2
  • Factor VII (Dade® Innovin®): CPN Level, N=40, Mean=91.6, Within Run %CV=2.5, Between Run %CV=1.5, Total %CV=2.7; CPP, N=40, Mean=32.5, Within Run %CV=2.3, Between Run %CV=2.1, Total %CV=3.0
  • Factor VIII (Dade® Actin® FSL): CPN Level, N=40, Mean=89.1, Within Run %CV=1.6, Between Run %CV=3.3, Total %CV=3.6; CPP, N=40, Mean=26.0, Within Run %CV=1.8, Between Run %CV=4.3, Total %CV=4.6
  • Antithrombin III (Berichrom® Antithrombin III(A)): CPN Level, N=40, Mean=97.4, Within Run %CV=1.3, Between Run %CV=4.6, Total %CV=4.8; CPP, N=40, Mean=32.3, Within Run %CV=2.7, Between Run %CV=7.6, Total %CV=8.1

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K964139, K992321, K955278

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

0

DEC - 7 1999

K993299

510(k) Summary of Safety and Effectiveness Information Sysmex ® Automated Coagulation Analyzer CA-1500 September 30, 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-1500

Common or Usual Name:Automated Coagulation Instruments
Classification Name:Coagulation instrument (21 CFR §864.5400)
Registration Number:
Manufacturing Site
Sysmex Corporation
Kobe, Japan9613959
Importer
Sysmex Corporation of America
One Wildlife Way
Long Grove, IL 60047-95961422681
Distributor
Dade Behring Inc.
Glasgow Site
P.O. Box 6101
Newark, DE 19714-61012517506

The CA-1500 is substantially equivalent in intended 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 and K992321; or the Behring Coagulation Timer (BCT), Dade Behring, Marburg, Germany which was cleared by FDA under Document Control No. K955278.

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 summary shows the results of the comparison studies between the proposed and the predicate devices.

1

510(k) Summary of Safety and Effectiveness Information Sysmex® Automated Coagulation Analyzer CA-1500 Page 2

TestPredicate DeviceSample Number (n)Coefficient of Correlation (r)Regression Equation
Prothrombin Time
(Innovin®, Seconds)CA-60001650.999Y = 0.97X + 0.09
Prothrombin Time
(Innovin®, INR)CA-60001650.999Y = 0.99X + 0.01
Prothrombin Time
(Thromborel® S, Seconds)BCT1630.998Y = 1.04X - 0.51
Prothrombin Time
(Thromborel® S, %)BCT1610.996Y = 1.08X - 2.44
Derived FibrinogenBCT1490.945Y = 1.17X - 0.54
Activated Partial Thromboplastin TimeCA-60001280.995Y = 1.00X + 0.15
Fibrinogen (Clauss)CA-60001150.985Y = 0.96X + 0.41
Factor VIICA-60001220.997Y = 1.04X - 1.67
Factor VIIICA-6000660.990Y = 0.96X + 4.25
Antithrombin IIIBCT1040.998Y = 0.97X - 4.72

Summary of Method Comparison Studies Between CA-1500 and CA-6000 or BCT

Summary of Precision Studies Sysmex® Automated Coagulation Analyzer CA-1500

Sysmex® Automated Coagulation Analyzer CA-1500
TestControl
LevelNMeanWithin
Run
%CVBetween
Run
%CVTotal
%CV
Prothrombin Time
(Dade® Innovin®, Seconds)CPN
Path. Pool4011.5
23.30.4
1.20.5
0.90.6
1.4
Prothrombin Time
(Dade® Innovin®, INR)CPN
Path. Pool401.1
2.20.4
1.20.5
0.90.6
1.4
Prothrombin Time
(Thromborel® S, Seconds)CPN
Path. Pool4011.8
28.40.6
0.62.0
3.02.1
3.0
Prothrombin Time
(Thromborel® S, %)CPN
Path. Pool4095.0
23.40.9
0.83.4
4.13.6
4.2
Derived Fibrinogen
(Dade® Innovin® on CA-1500)CPN
Path. Pool401.8
5.03.7
2.43.2
1.24.7
2.6
Activated Partial Thromboplastin
Time (Dade® Actin® FSL)CPN
Path. Pool4028.1
39.52.1
0.51.4
1.92.4
2.0
Fibrinogen (Clauss)
(Dade® Thrombin Reagent)CPN
CPP402.7
0.71.9
8.42.7
4.93.2
9.2
Factor VII
(Dade® Innovin®)CPN
CPP4091.6
32.52.5
2.31.5
2.12.7
3.0
Factor VIII
(Dade® Actin® FSL)CPN
CPP4089.1
26.01.6
1.83.3
4.33.6
4.6
Antithrombin III
(Berichrom® Antithrombin III(A))CPN
CPP4097.4
32.31.3
2.74.6
7.64.8
8.1

2

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 lines representing its wings or feathers. The eagle is facing to the left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.

DEC - 7 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

K993299 Trade Name: Sysmex® Automated Coagulation Analyzer CA-1500 Regulatory Class: II Product Code: GKP Dated: September 30, 1999 Received: October 1, 1999

Dear Mr. Riesgo:

Re:

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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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.

3

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

4

510(k) Number (if known): K9932999

Device Name: Sysmex® Automated Coagulation Analyzer CA-1500

Indications for Use:

The intended use of the Sysmex® CA-1500 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 .
    Calculated Parameters

  • . PT Ratio

  • PT INR

  • PT % ●

  • Extrinsic Factors (II, V, VII, X) ● Intrinsic Factors (VIII, IX, XI, XII) .

  • Derived Fibrinogen ●

  • Factor Assays % Activity .

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Peter E. Madini

Clinical Laboratory Device

Prescription Use (Per 21 CFR 801.109)

OR

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