← Product Code [GGP](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GGP) · K981817 # COAMATIC PLASMIN INHIBITOR (K981817) _Instrumentation Laboratory CO · GGP · Sep 28, 1998 · Hematology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GGP/K981817 ## Device Facts - **Applicant:** Instrumentation Laboratory CO - **Product Code:** [GGP](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GGP.md) - **Decision Date:** Sep 28, 1998 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 864.7290 - **Device Class:** Class 2 - **Review Panel:** Hematology ## Indications for Use Coamatic® Plasmin Inhibitor is an in vitro diagnostic test for the quantitative determination of plasmin inhibitor activity in human citrated plasma using microplate, test tube and automated methods. Plasmin inhibitor, the major fast-acting inhibitor of the fibrinolytic system, also know as ca-antiplasmin, is an important regulator of the fibrinolytic system. Congenital deficiencies are associated with haemorragic problems. Decreased levels of plasmin inhibitor are observed in liver diseases and DIC. Increased levels have been reported during post-operative episodes. ## Device Story Coamatic® Plasmin Inhibitor is an in vitro diagnostic reagent kit for measuring plasmin inhibitor (alpha-antiplasmin) activity in human citrated plasma. Used in clinical laboratories by technicians; compatible with microplate, test tube, and automated analyzer platforms (e.g., ACL 300, Cobas Mira, MLA Electra). The assay quantifies fibrinolytic system regulation; results assist clinicians in diagnosing congenital deficiencies, liver disease, or DIC, and monitoring post-operative states. Benefits include identification of hemorrhagic risk factors through standardized activity measurement. ## Clinical Evidence Bench testing only. Method comparison studies (n=32 to 61) against predicate Coatest® Antiplasmin showed correlation coefficients (r) ranging from 0.94 to 0.97 across various platforms (ACL 300, Cobas Mira, MLA Electra, test tube, microplate). Precision studies reported CVs of 5.9% at 44.8% mean concentration and 2.7% at 99.3% mean concentration. ## Technological Characteristics In vitro diagnostic reagent for quantitative plasmin inhibitor activity. Utilizes chromogenic/enzymatic test principle identical to predicate. Compatible with standard clinical laboratory instrumentation (microplate, test tube, automated analyzers). ## Predicate Devices - Coatest® Antiplasmin ([K833890](/device/K833890.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}------------------------------------------------ # SEP 28 1998 . D 1 ﻬﺎ ﻓﻬ # Section 3 Coamatic® Plasmin Inhibitor - 510(k) SUMMARY (Summary of Safety and Effectiveness) #### Submitted by: Carol Marble Senior Regulatory Affairs Specialist Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02173 Phone: (781) 861-4467 Fax: (781) 861-4464 ### Contact Persons: Carol Marble Phone: (781) 861-4467 #### Summary Prepared: May 21, 1998 #### Name of the device: Coamatic® Plasmin Inhibitor ### Classification name(s): 864.7290 Factor Deficiency Test Class II 81GGP Test, Qualitative and Quantitative Factor Deficient #### Identification of predicate device(s): K833890 Coatest® Antiplasmin #### Description of the device/intended use(s): Coamatic® Plasmin Inhibitor is an in vitro diagnostic test for the quantitative determination of plasmin inhibitor activity in human citrated plasma using microplate, test tube and automated methods. Plasmin inhibitor, the major fast-acting inhibitor of the fibrinolytic system, also know as a - antiplasmin, is an important regulator of the fibrinolytic system. Congenital deficiencies are associated with haemorragic problems. Decreased levels of plasmin inhibitor are observed in liver diseases and DIC. Increased levels have been reported during post-operative episodes. ### Statement of How the Technological Characteristics of the Device Compare to the Predicate device: Coamatic® Plasmin Inhibitor uses the same test principle as the predicate Coatest® Antiplasmin and is substantially equivalent in performance, intended use, and safety and effectiveness. #### Summary of Performance Data: In method comparison studies comparing the new Coamatic® Plasmin Inhibitor to the predicate Coatest® Antiplasmin, the correlation (r) on an ACL 300 (n=61) was 0.95, on a Cobas Mira (n=43) was 0.97, on an MLA Electra (n=43) was 0.97, and using the test tube (n=32) and microplate (n=54) methods was 0.96 and 0.94, respectively. Within run precision assessed over multiple runs gave a CV of 5.9% (at a mean plasmin inhibitor concentration of 44.8%) and 2.7% (at a mean plasmin inhibitor concentration of 99.3%). Section 3 Coamatic® Plasmin Inhibitor 510(k) Page 1 of 1 {1}------------------------------------------------ Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of a human figure, with three overlapping profiles facing to the right. SEP 28 1998 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Ms. Carol Marble Requlatory Affairs Manager Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, Massachusetts 02173 Re : K981817/S1 Trade Name: Coamatic® Plasmin Inhibitor Regulatory Class: II Product Code: GGP Dated: September 8, 1998 Received: September 9, 1998 Dear Ms. Marble: 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 Reqister. 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. {2}------------------------------------------------ #### 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 diaqnostic 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 requiation 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 {3}------------------------------------------------ # Indications for Use Statement 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: Coamatic® Plasmin Inhibitor # Indications for Use: Coamatic® Plasmin Inhibitor is an in vitro diagnostic test for the quantitative determination of plasmin inhibitor activity in human citrated plasma using microplate, test tube and automated methods. Plasmin inhibitor, the major fast-acting inhibitor of the fibrinolytic system, also know as ca-antiplasmin, is an important regulator of the fibrinolytic system. Congenital deficiencies are associated with haemorragic problems. Decreased levels of plasmin inhibitor are observed in liver diseases and DIC. Increased levels have been reported during post-operative episodes. (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 | | | 510(k) Number | K981817 | | Prescription Use (Per 21 CFR 801.019) |
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| OR | Over-The-Counter Use | |---------------------------------------|--------------|----|----------------------| |---------------------------------------|--------------|----|----------------------| Section 2 Coamatic® Plasmin Inhibitor 510(k) Page 1 of 1 --- **Source:** [https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GGP/K981817](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GGP/K981817) **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