(46 days)
IL Test™ Protein C is an in vitro diagnostic test for the quantitative determination of Protein C in human citrated plasma based on a synthetic chromogenic substrate. Protein C deficiency is associated with recurrent venous thrombosis, especially in young adults. Acquired deficiencies of Protein C are associated with hepatic disorders, oral anticoagulant therapy and disseminated intravascular coagulation.
IL Test™ Protein C is an in vitro diagnostic test for the quantitative determination of Protein C in human citrated plasma based on a synthetic chromogenic substrate.
The provided text describes the IL Test™ Protein C, an in vitro diagnostic device, and its performance in comparison to a predicate device.
Here's an analysis of the acceptance criteria and study data:
1. Table of Acceptance Criteria and Reported Device Performance
The submission doesn't explicitly state quantitative acceptance criteria in a dedicated section. However, based on the Statement of How the Technological Characteristics of the Device Compare to the Predicate device, the implied acceptance criterion is that the new device is "substantially equivalent in performance, intended use and safety and effectiveness" to the predicate device. The performance data provided supports this claim of substantial equivalence.
| Performance Metric | Acceptance Criterion (Implied for Substantial Equivalence to Predicate) | Reported Device Performance (IL Test™ Protein C) |
|---|---|---|
| Method Comparison(Correlation (r) with Predicate Device) | High correlation (implied "substantially equivalent" to predicate's performance) | ACL 300 vs Predicate (Coamatic® Protein C on Cobas Mira): r = 0.990ACL Futura vs Predicate (Coamatic® Protein C on Cobas Mira): r = 0.996 |
| Within-Run Precision (CV%)(Low % CV indicates good precision) | Low Coefficient of Variation (CV%) (implied "substantially equivalent" to predicate's precision) | ACL 300:- At 52.4% activity: 1.6% CV- At 104.6% activity: 1.4% CVACL Futura:- At 51.4% activity: 2.1% CV- At 105.6% activity: 1.4% CV |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 52 plasma samples were used in the method comparison studies.
- Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective. It just states "method comparison studies evaluating 52 plasma samples."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this device. The IL Test™ Protein C is an in vitro diagnostic test for quantitative determination of a biomarker (Protein C). The "ground truth" for evaluating its performance is another established quantitative method (the predicate device) or reference methods, not subjective expert assessment of images or clinical cases.
4. Adjudication Method for the Test Set
This is not applicable as the evaluation is based on quantitative measurements against a predicate device, not subjective interpretation requiring adjudication.
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
This is not applicable. The device is an in vitro diagnostic quantitative test, not an AI-assisted diagnostic tool that involves human readers interpreting cases.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the studies presented are standalone performance evaluations of the IL Test™ Protein C device. The method comparison and precision studies assess the device's inherent analytical performance without human interpretation or intervention beyond performing the test according to its instructions.
7. The Type of Ground Truth Used
The "ground truth" for evaluating the IL Test™ Protein C was the results obtained from the legally marketed predicate device, Coamatic® Protein C. This is a form of comparative ground truth where the new device's performance is measured against an already accepted and established method.
8. The Sample Size for the Training Set
This information is not provided in the submission. For an in vitro diagnostic test, there isn't typically a "training set" in the machine learning sense. Performance validation usually involves analytical studies (like precision, accuracy, linearity) using characterized samples and method comparison studies against a predicate or reference method.
9. How the Ground Truth for the Training Set was Established
As mentioned above, the concept of a "training set" with established ground truth in the context of machine learning is not applicable here. For an IVD device, analytical performance characteristics are established through various lab studies. The "ground truth" for comparison was the predicate device's results.
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APR 21 1998 Section 3 IL Test™ Protein C - 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 (781) 861-4464 Fax:
Contact Person:
Carol Marble Phone: (781) 861-4467
Summary Prepared:
March 5, 1998
Name of the device:
IL Test™ Protein C
Classification name(s):
864.7290 Factor Deficiency Test Class II Test, Qualitative and Quantitative Factor Deficient 81GGP
Identification of predicate device(s):
K922201 Coamatic® Protein C
Description of the device/intended use(s):
IL Test™ Protein C is an in vitro diagnostic test for the quantitative determination of Protein C in human citrated plasma based on a synthetic chromogenic substrate. Protein C deficiency is associated with recurrent venous thrombosis, especially in young adults. Acquired deficiencies of Protein C are associated with hepatic disorders, oral anticoagulant therapy and disseminated intravascular coagulation.
Statement of How the Technological Characteristics of the Device Compare to the Predicate device:
The new IL Test™ Protein C uses the same test principle as the predicate Coamatic® Protein C 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 0.990 for the new IL Test™ Protein C on the ACL 300 as compared to the predicate Coamatic® Protein C on the Cobas Mira and 0.996 for the new IL Test™ Protein C on the ACL Futura as compared to the predicate Coamatic® Protein C on the Cobas Mira.
On the ACL 300, within run precision assessed over multiple runs using 2 levels of plasma gave a CV of 1.6% (at a mean of 52.4% activity) and 1.4% (at a mean of 104.6% activity). On the ACL Futura, within run precision accessed over multiple runs using 2 levels of plasma gave a CV of 2.1% (at a mean of 51.4% activity) and 1.4% (at a mean of 105.6% activity).
IL Test™ Protein C 510(k)
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Carol Marble .Senior Regulatory Affairs Specialist Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, Massachusetts 02173-3190
Re : K980875 IL TEST™ Protein C Regulatory Class: II Product Code: GGP Dated: March 5, 1998 March 6, 1998 Received:
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. 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 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 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 Sitman
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): ____________________________________________________________________________________________________________________________________________________
Device Name: IL Test™ Protein C
Indications for Use:
IL Test™ Protein C is an in vitro diagnostic test for the quantitative determination of Protein C in human citrated plasma based on a synthetic chromogenic substrate. Protein C deficiency is associated with recurrent venous thrombosis, especially in young adults. Acquired deficiencies of Protein C are associated with hepatic disorders, oral anticoagulant therapy and disseminated intravascular coagulation.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
P. Berlaust (for A. Montgomery)
Sir Off
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K980875
Prescription Use
(Per 21 CFR 801.019)
OR Over-The-Counter Use
Section 2
IL Test™ Protein C 510(k)
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§ 864.7290 Factor deficiency test.
(a)
Identification. A factor deficiency test is a device used to diagnose specific coagulation defects, to monitor certain types of therapy, to detect coagulation inhibitors, and to detect a carrier state (a person carrying both a recessive gene for a coagulation factor deficiency such as hemophilia and the corresponding normal gene).(b)
Classification. Class II (performance standards).