(59 days)
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No
The 510(k) summary describes a calibrator for a diagnostic assay, which is a chemical reagent used for calibration. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
This device is a calibrator for a diagnostic assay, used to determine the plasma level of antithrombin III, which is a diagnostic purpose, not a therapeutic one.
Yes
The device is used to determine plasma levels of antithrombin III, which helps monitor heparin administration and diagnose thrombophilia.
No
The device description clearly indicates this is a physical product ("This product is designed for use with Accucolor Antithrombin III Assay Kit (CRS117A)") and a reference material ("This product provides a reference material"). It is a calibrator for a diagnostic assay, not a software application.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is "for use with the Sigma Diagnostics ACCUCOLOR™ Antithrombin III (AT-III) to determine the plasma level of antithrombin III". This determination is used for monitoring heparin administration and diagnosing thrombophilia. These are diagnostic purposes performed on biological samples (plasma).
- Device Description: The description mentions it's designed for use with an "Accucolor Antithrombin III Assay Kit" and provides information about normal ranges of AT-III in plasma. This further reinforces its use in a laboratory setting for analyzing biological samples.
- Performance Studies: The performance studies mention its use for "calibration of ATIII assays," which are in vitro tests.
The definition of an IVD is a medical device that is used to examine specimens, such as blood, urine, or tissue, from the human body to provide information for diagnosis, monitoring, or screening. This device fits that definition perfectly.
N/A
Intended Use / Indications for Use
Sigma Diagnostics ACCUCOLOR™ High Calibrator is for use with the Sigma Diagnostics ACCUCOLOR™ Antithrombin III (AT-III) to determine the plasma level of antithrombin III (a substance which acts with the anticoagulant heparin to prevent coagulation). This determination is used to monitor the administration of heparin in the treatment of thrombosis. The determination may also be used in the diagnosis of thrombophilia (a congenital deficiency of antithrombin III).
Product codes (comma separated list FDA assigned to the subject device)
GIZ, JBQ
Device Description
This product is designed for use with Accucolor Antithrombin III Assay Kit (CRS117A). The normal range of plasma Antithrombin III (AT-III) has been reported from 79-125% in Plasma 1-234 A normal population range determined at Sigma Diagnostics (n=70) was 83-119% (mean 101.1+9.8). This product provides a reference material with an assigned value slightly above the normal range. The human source material from which this product was found negative for HbsAg and for antibodies against HCV, HIV-1, and HIV-2 by approved test methods. The "Precautions"section of the data sheet instructs the user in handling and disposal of this product and directs the user to sources of additional information on the product.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The safety and effectiveness of the Sigma Accucolor High Calibrator (A3089) has been demonstrated by its substantial equivalence to Sigma Product A7432.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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1113274
510(k) NOTIFICATION Sigma Diagnostics Inc. ACCUCOLOR™ High Calibrator
OCT 37 1997
ATTACHMENT 1
Summary of Safety and Effectiveness
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1
Summary of Safety and Effectiveness Accucolor High Calibrator. Product No. A3089
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1
This product is designed for use with Accucolor Antithrombin III Assay Kit (CRS117A). The normal range of plasma Antithrombin III (AT-III) has been reported from 79-125% in Plasma 1-234 A normal population range determined at Sigma Diagnostics (n=70) was 83-119% (mean 101.1+9.8). This product provides a reference material with an assigned value slightly above the normal range.
The safety and effectiveness of the Sigma Accucolor High Calibrator (A3089) has been demonstrated by its substantial equivalence to Sigma Product A7432. Both products are used for the calibration of ATIII assays. Both products have values assigned using a secondary standard, which was assigned from a traceable WHO International Reference Preparation for Antithrombin III.
The human source material from which this product was found negative for HbsAg and for antibodies against HCV, HIV-1, and HIV-2 by approved test methods. The "Precautions"section of the data sheet instructs the user in handling and disposal of this product and directs the user to sources of additional information on the product.
- Odegard O. Lie M. Ablidgaard U. Heparin Cofactor Activity Measured with an 1. Amidolytic Method. 1975 Thrombosis Research 6:287-294.
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- Rosenberg R, Bauer K. The Heparin-Antithrombin System: A Natural Anticoagulant Mechanism. In Hemostasis and Thrombosis; Basic Principles and Clinical Practice, Colman R, Hirsh J, Marder V, and Salzman E. Eds. Third Edition, 1994 pp 837-860. Lippincott Co., Philadelphia, PA. USA.
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- Bick R. Clinical Relevance of Antithrombin III. 1982 Seminars in Thrombosis and Hemostasis 8:276-287.
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- Demers C, Henderson P, Blajchman M, Wells M, Mitchell L, Johnston M, Ofosu F, Fernandez-Rachubinski F, Andrew M, Hirsh J, Ginsberg J. An Antithrombin III Assay Based on Factor Xa Inhibition Provides a More Reliable Test to Identify Congenital Antithrombin III Deficiency Than an Assay Based on Thrombin Inhibition. 1993 Thrombosis and Haemostasis 69:231-235.
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Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract design resembling an eagle or bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird symbol. The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 3 1 1997
William Gilbert, Ph.D. Manager, Scientific Affairs Sigma Diagnostics Inc. 545 South Ewinq Avenue St. Louis, Missouri 63103
Re : K973274 ACCUCOLOR™ High Calibrator Requlatory Class: II Product Code: GIZ, JBQ Dated: October 2, 1997 Received: October 3, 1997
Dear Dr. Gilbert:
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 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 Requlations, 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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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/dsmamain.html".
Sincerely yours,
Steven Bitman
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):
Device Name: _Sigma Diagnostics ACCUCOLOR™ High Calibrator
Indications For Use:
Sigma Diagnostics ACCUCOLOR™ High Calibrator is for use with the Sigma Diagnostics ACCUCOLOR™ Antithrombin III (AT-III) to determine the plasma level of antithrombin III (a substance which acts with the anticoagulant heparin to prevent coagulation). This determination is used to monitor the administration of heparin in the treatment of thrombosis. The determination may also be used in the diagnosis of thrombophilia (a congenital deficiency of antithrombin III).
(PLÉASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number
Prescription Use
(Per 21 CFR 801.109) /
OR
Over-The-Counter Use