(28 days)
The i-STAT Activated Partial Thromboplastin (aPTT), Prothrombine Time (PT), and Activated Clotting Time (ACT) Controls are intended to be used with the i-STAT portable Clinical Analyzer and i-STAT aPTT, PT, and ACT test cartridges to provide a method for verifying the integrity of newly received cartridges.
The controls produce clotting times within normal ranges and abnormal ranges to indicate that the test cartridges are functioning properly.
Not Found
This document is a 510(k) clearance letter from the FDA for the i-STAT Coagulation Control Set. It does not contain information about a study that proves the device meets specific acceptance criteria in the way a clinical trial or performance study would for a new diagnostic or AI-powered device.
This clearance is based on substantial equivalence to a predicate device, meaning the new device is as safe and effective as another legally marketed device. The letter primarily confirms that the device can be marketed based on this determination.
Therefore, many of the requested points regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication, and MRMC studies are not applicable to the information provided in this regulatory document.
However, I can extract the information that is present:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes the intended use of the controls as "to provide a method for verifying the integrity of newly received cartridges" and states that "The controls produce clotting times within normal ranges and abnormal ranges to indicate that the test cartridges are functioning properly."
While a formal table of acceptance criteria with specific threshold values (e.g., +/- 10% of expected value) is not provided in this FDA letter, the implied acceptance criteria are that the i-STAT Coagulation Control Set, when used with i-STAT aPTT, PT, and ACT test cartridges, produces:
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Produces clotting times within normal ranges. | The controls do produce clotting times within normal ranges (as verified by the substantial equivalence determination). |
| Produces clotting times within abnormal ranges. | The controls do produce clotting times within abnormal ranges (as verified by the substantial equivalence determination). |
| Indicative of proper functioning of test cartridges. | The controls do indicate that test cartridges are functioning properly (as verified by the substantial equivalence determination). |
| Equivalent in safety and effectiveness to a legally marketed predicate device. | The device is substantially equivalent to a predicate device (FDA's finding). |
2. Sample size used for the test set and the data provenance: Not applicable to this type of regulatory submission. The FDA relies on the manufacturer's data demonstrating substantial equivalence, which would include internal testing, but the details of such testing (like sample size for a "test set" in the context of an AI/diagnostic algorithm) are not explicitly in this letter.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document pertains to coagulation control solutions, not an AI or diagnostic algorithm requiring expert ground truth for image or data interpretation.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done: No. This is not relevant for a coagulation control set.
6. If a standalone (algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a control solution for an analyzer, not a standalone algorithm.
7. The type of ground truth used: For a control solution, the "ground truth" would be the known, expected values or ranges of the clotting parameters being measured, established through analytical methods and possibly reference laboratories. This is not explicitly stated but is the inherent nature of a control.
8. The sample size for the training set: Not applicable. This device is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 1 5 1998
Michael D. Bick, Ph.D. . Chief Executive Officer Biopool International 6025 Nicolle Street Ventura, California 93003
Re: K981752 i-STAT Coaqulation Control Set Regulatory Class: I Product Code: GGN Dated: May 15, 1998 Received: May 18, 1998
Dear Dr. Bick:
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 aqainst 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. ದ 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 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 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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Page 1 of 1
510(k) Number (if known):
4981752
Device Name:
i-STAT Coagulation Control Set
Indications for Use:
The i-STAT Activated Partial Thromboplastin (aPTT), Prothrombine Time (PT), and Activated Clotting Time (ACT) Controls are intended to be used with the i-STAT portable Clinical Analyzer and i-STAT aPTT, PT, and ACT test cartridges to provide a method for verifying the integrity of newly received cartridges.
The controls produce clotting times within normal ranges and abnormal ranges to indicate that the test cartridges are functioning properly.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
2981752
(Division Sign-Off)
Division of Laboratory...evices
510(k) Number.
Over-The-Counter Use
Prescription Use 1 (Per 21 CFR 801.109)
OR
(Optional Format 1-2-96)
な
§ 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.