← Product Code [JBQ](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBQ) · K022550 # COAMATIC LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTS (K022550) _Instrumentation Laboratory CO · JBQ · Aug 27, 2002 · Hematology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBQ/K022550 ## Device Facts - **Applicant:** Instrumentation Laboratory CO - **Product Code:** [JBQ](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBQ.md) - **Decision Date:** Aug 27, 2002 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 864.7060 - **Device Class:** Class 2 - **Review Panel:** Hematology ## Indications for Use Coamatic® LR Antithrombin is intended for the quantitative determination of the heparin cofactor activity of antithrombin (AT) in human citrated plasma. All components of the kit are in liquid formulation (LR = Liquid Reagents). Antithrombin is the most important natural inhibitor of the coagulation cascade. By inhibiting the coagulation proteases, especially thrombin, factor Xa and factor IXa, antithrombin prevents uncontrolled coagulation and thrombosis. Plasma is incubated with an excess of Factor Xa (FXa) in the presence of heparin. The residual activity of FXa is determined by the rate of hydrolysis of the chromogenic substrate S-2772. The pNA release measured at 405 nm is inversely proportional to the AT level in the range 15-125% of normal plasma. ## Device Story Coamatic® LR Antithrombin is an in vitro diagnostic reagent kit for measuring antithrombin activity in human citrated plasma. The assay utilizes a chromogenic method: plasma is incubated with excess Factor Xa and heparin; residual Factor Xa hydrolyzes chromogenic substrate S-2772; pNA release is measured spectrophotometrically at 405 nm. The rate of pNA release is inversely proportional to antithrombin levels. The device is used in clinical laboratory settings on automated coagulation analyzers (e.g., ACL Futura). Healthcare providers use the quantitative output to evaluate antithrombin levels, which helps assess the patient's risk for uncontrolled coagulation and thrombosis. ## Clinical Evidence Bench testing only. Method comparison study evaluated 61 citrated plasma samples (range 8.6% to 121.5% AT activity) on an ACL Futura analyzer compared to the predicate on an ACL 9000, yielding a slope of 1.011, intercept of 0.4889, and r=0.995. Precision studies (n=60) showed total CV% ranging from 3.52% to 11.09% across three control levels. ## Technological Characteristics Liquid reagent kit for chromogenic antithrombin assay. Principle: Factor Xa inhibition assay using chromogenic substrate S-2772. Measurement: Spectrophotometric detection at 405 nm. Designed for use on automated coagulation analyzers. ## Regulatory Identification An antithrombin III assay is a device that is used 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). ## Predicate Devices - IL Test™ Liquid Antithrombin ([K994238](/device/K994238.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ # AUG 2 7 2002 IC022552 # Section 3 Coamatic® LR Antithrombin - 510(k) Summary (Summary of Safety and Effectiveness) ## Submitted by: Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02421 Phone: 781-861-4467 Fax: 781-861-4207 ### Contact Person: Carol Marble, Regulatory Affairs Manager Phone: 781-861-4467 / Fax: 781-861-4207 #### Summary Prepared: August 1, 2002 #### Name of the Device: Coamatic® LR Antithrombin #### Classification Name(s): | 864.7060 | Antithrombin III Assay | Class II | |----------|-------------------------------|----------| | 81JBQ | Antithrombin III Quantitation | | ## Identification of Predicate Device(s): K994238 IL Test™ Liquid Antithrombin ### Description of the Device/Intended use(s): Coamatic® LR Antithrombin is intended for the quantitative determination of the heparin cofactor activity of antithrombin (AT) in human citrated plasma. All components of the kit are in liquid formulation (LR = Liquid Reagents). Antithrombin is the most important natural inhibitor of the coagulation cascade. Bv inhibiting the coagulation proteases, especially thrombin, factor Xa and factor IXa, antithrombin prevents uncontrolled coagulation and thrombosis. Plasma is incubated with an excess of Factor Xa (FXa) in the presence of heparin. The residual activity of FXa is determined by the rate of hydrolysis of the chromogenic substrate S-2772. The pNA release measured at 405 nm is inversely proportional to the AT level in the range 15-125% of normal plasma. ### Statement of Technological Characteristics of the Device Compared to Predicate Device: Coamatic® LR Antithrombin is substantially equivalent in performance to the predicate device: IL Test™ Liquid Antithrombin {1}------------------------------------------------ # Section 3 Coamatic® LR Antithrombin - 510(k) Summary (Summary of Safety and Effectiveness) #### Summary of Performance Data: ### Method Comparison In a method comparison study evaluating 61 citrated plasma samples with Antithrombin levels ranging in value from 8.6% to 121.5% AT activity, the correlation statistics for Coamatic® LR Antithrombin on an ACL Futura versus the predicate device on an ACL 9000 are shown below: | System | Slope | Intercept | r | Reference Method | |------------|-------|-----------|-------|---------------------------------| | ACL Futura | 1.011 | 0.4889 | 0.995 | IL TestTM Liquid AT on ACL 9000 | ### Precision Within run and total precision assessed over multiple runs using three levels of control plasma gave the following results: | ACL Futura | | | | | | |-------------|------------------|---|-------------|----|--| | Mean (% AT) | CV% (Within run) | n | CV% (Total) | n | | | 114 | 1.96 | 6 | 3.52 | 60 | | | 59 | 6.21 | 6 | 6.43 | 60 | | | 29 | 8.45 | 6 | 11.09 | 60 | | {2}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES 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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping to create a sense of depth. Food and Drug Administration 098 Gaither Road Rockville MD 20850 AUG 2 7 2002 Ms. Carol Marble Regulatory Affairs Manager Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, Massachusetts 02421-3125 k022550 Re: Trade/Device Name: Coamatic® LR Antithrombin Regulation Number: 21 CFR § 864.7060 Regulation Name: Antithrombin III Assay Regulatory Class: II Product Code: JBO Dated: August 1, 2002 Received: August 2, 2002 Dear Ms. Marble: 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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ 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 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}------------------------------------------------ # Indications for Use Statement 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: Coamatic® LR Antithrombin # Indications for Use: Coamatic® LR Antithrombin is intended for the quantitative determination of the heparin cofactor activity of antithrombin (AT) in human citrated plasma. All components of the kit are in liquid formulation (LR = Liquid Reagents). Antithrombin is the most important natural inhibitor of the coagulation cascade. By inhibiting the coagulation proteases, especially thrombin, factor Xa and factor IXa, antithrombin prevents uncontrolled coagulation and thrombosis. Plasma is incubated with an excess of Factor Xa (FXa) in the presence of heparin. The residual activity of FXa is determined by the rate of hydrolysis of the chromogenic substrate S-2772. The pNA release measured at 405 nm is inversely proportional to the AT level in the range 15-125% of normal plasma. #### (PLEASE 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 | K022550 | | 510(k) Number | | Prescription Use __________ OR Over-The-Counter Use __________ (Per 21 CFR 801.019) Coamatic® LR Antithrombin 510(k) --- **Source:** [https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBQ/K022550](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBQ/K022550) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com