(52 days)
IL Test™ Antithrombin is an in vitro diagnostic test for the quantitative determination of Antithrombin in human plasma to monitor the administration of heparin in the treatment of thrombosis and as an aid in the diagnosis of thrombophilia (a congenital deficiency of Antithrombin).
IL Test™ Antithrombin is an in vitro diagnostic test for the quantitative determination of Antithrombin in human plasma to monitor the administration of heparin in the treatment of thrombosis and as an aid in the diagnosis of thrombophilia (a congenital deficiency of Antithrombin).
The provided text describes the IL Test™ Antithrombin device and its performance relative to a predicate device. Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" for the IL Test™ Antithrombin. Instead, it demonstrates performance by comparing it to a predicate device and reporting precision metrics. For the purpose of this response, the performance metrics reported for the new device can be considered against the implicit acceptance that they demonstrate substantial equivalence to the predicate.
| Acceptance Criteria (Implicit) | Reported Device Performance (IL Test™ Antithrombin) |
|---|---|
| Method Comparison (Correlation to Predicate) | |
| Substantial equivalence to predicate device (implied by high correlation) | ACL 300 vs. predicate Coamatic® Antithrombin: r = 0.992 (evaluated using 52 plasma samples) |
| ACL Futura vs. predicate Coamatic® Antithrombin: r = 0.991 (evaluated using 52 plasma samples) | |
| Within-Run Precision (CV%) | |
| Low coefficient of variation (CV%) for consistency | ACL 300: - Mean 49.2% activity: CV = 3.6% - Mean 103.7% activity: CV = 1.6% |
| ACL Futura: - Mean 48.7% activity: CV = 3.9% - Mean 104.5% activity: CV = 3.0% |
2. Sample size used for the test set and the data provenance
- Sample Size: 52 plasma samples
- Data Provenance: Not explicitly stated (e.g., country of origin). Since it's a medical device for human plasma, the samples were presumably human in origin. The study appears to be retrospective given the comparison to an existing predicate device using collected samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. For in vitro diagnostic devices like this, the "ground truth" is typically established by the reference method (the predicate device in this case) and the inherent biological characteristics of the samples, rather than human expert interpretation of raw data.
4. Adjudication method for the test set
Not applicable. The study involves quantitative measurement and comparison to a predicate device, not qualitative assessments requiring adjudication by multiple experts.
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 in vitro diagnostic device for quantitative determination in human plasma, not an AI-assisted diagnostic tool that involves human readers interpreting images or other data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, this study represents a standalone performance evaluation of the IL Test™ Antithrombin device itself, without human-in-the-loop interaction for interpretation beyond standard laboratory operation. The device directly measures Antithrombin levels.
7. The type of ground truth used
The ground truth for this comparison study was established by the predicate device, Coamatic® Antithrombin. The new device's measurements were compared against the established measurements from the predicate device to demonstrate substantial equivalence.
8. The sample size for the training set
This document describes a performance evaluation (test set), not the development of an algorithm requiring a separate training set. Therefore, this information is not applicable/provided.
9. How the ground truth for the training set was established
As described in point 8, this document does not refer to a training set for an algorithm.
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Section 3 IL Test™ Antithrombin - 510(k) SUMMARY (Summary of Safety and Effectiveness)
Submitted by:
APR - 2 1998
Carol Marble Senior Regulatory Affairs Specialist Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02173 Phone: (781) 861-4467 (781) 861-4464 Fax:
Contact Person:
Carol Marble Phone: (781) 861-4467
Summary Prepared:
February 6, 1998
Name of the device:
IL Test™ Antithrombin
Classification name(s):
| 864.7060 | Antithrombin III Assay | Class II |
|---|---|---|
| 81JBQ | Antithrombin III Quantitation |
Identification of predicate device(s):
Coamatic® Antithrombin (originally named Coamate Antithrombin) K915083
Description of the device/intended use(s):
IL Test™ Antithrombin is an in vitro diagnostic test for the quantitative determination of Antihrombin in human plasma to monitor the administration of heparin in the treatment of thrombosis and as an aid in the diagnosis of thrombophilia (a congenital deficiency of Antithrombin).
Statement of How the Technological Characteristics of the Device Compare to the Predicate device:
The new IL Test™ Antithrombin uses the same test principle as the predicate Coamatic® Antithrombin and is substantially equivalent in performance, intended use and safety and effectiveness.
Summary of Performance Data:
In method comparison studies evaluating 52 plasma samples, the correlation (r) was 0.992 for the new IL Test™ Antithrombin on the ACL 300 as compared to the predicate Coamatic® Antithrombin on the Cobas Mira and 0.991 for the new IL Test™ Antithrombin on the ACL Futura as compared to the predicate Coamatic® Antithrombin on the Cobas Mira.
On the ACL 300, within run precision accessed over multiple runs using 2 levels of sample gave a CV of 3.6% (at a mean of 49.2% activity) and 1.6% (at a mean of 103.7% activity). On the ACL Futura, within run precision accessed over multiple runs using 2 levels of sample gave a CV of 3.9% (at a mean of 48.7% activity) and 3.0% (at a mean of 104.5% activity).
Page 1 of 1 IL Test™ Antithrombin 510(k) Section 3
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR - 2 1998
Carol Marble Senior Requlatory Affairs Specialist Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, Massachusetts 02173-3190
K980499 Re : IL Test™ Antithrombin Regulatory Class: II Product Code: JBO Dated: February 6, 1998 Received: February 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 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 The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. 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 requlations.
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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/dsmamain.html".
Sincerely yours,
Steven Litman
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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Indications for Use Statement
510(k) Number (if known): _ H980499
Device Name: IL Test™ Antithrombin
Indications for Use:
IL Test™ Antithrombin is an in vitro diagnostic test for the quantitative determination of Antihrombin in human plasma to monitor the administration of heparin in the treatment of thrombosis and as an aid in the diagnosis of thrombophilia (a congenital deficiency of Antithrombin).
(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. K980499
Prescription Use
(Per 21 CFR 801.019)
OR Over-The-Counter Use _
Over-The-Counter Use
Section 2
IL Test™ Antithrombin 510(k)
Page 1 of 1
§ 864.7060 Antithrombin III assay.
(a)
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).(b)
Classification. Class II (performance standards).