(71 days)
Calibration Plasma LMW Heparin is an in vitro diagnostic product intended as a tri-level calibrator to prepare calibration curves for use in chromogenic heparin assays.
Calibration Plasma LMW Heparin is an in vitro diagnostic product intended as a tri-level calibrator to prepare calibration curves for use in chromogenic heparin assays.
The provided text describes a 510(k) premarket notification for a medical device called "Calibration Plasma LMW Heparin," not an AI/ML SaMD product. Therefore, many of the requested categories related to AI/ML device studies (such as MRMC studies, ground truth establishment for training sets, number of experts, and adjudication methods) are not applicable to this submission.
However, I can extract information related to the device's performance study and acceptance criteria as presented in the document.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" for the CV percentages, but it lists the performance data from a precision study. For this type of in vitro diagnostic calibrator, the reported precision (CV%) is the key performance metric. The predicate device's performance would typically serve as an implicit benchmark for substantial equivalence.
| Description | Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Calibration Plasma LMW Heparin Level 1 | Within Run %CV | Not explicitly stated (expected to be low for calibrators, comparable to predicate) | 0.018 (SD) |
| Between Run %CV | Not explicitly stated | 0.008 (SD) | |
| Total %CV | Not explicitly stated | 0.024 (SD) | |
| Calibration Plasma LMW Heparin Level 2 | Within Run %CV | Not explicitly stated | 2.99 % |
| Between Run %CV | Not explicitly stated | 1.47 % | |
| Total %CV | Not explicitly stated | 4.24 % | |
| Calibration Plasma LMW Heparin Level 3 | Within Run %CV | Not explicitly stated | 2.21 % |
| Between Run %CV | Not explicitly stated | 0.00 % | |
| Total %CV | Not explicitly stated | 2.58 % |
2. Sample sized used for the test set and the data provenance
- Sample Size: The precision study was performed "over multiple days with multiple runs (n=60)" for each of the tri-level calibrators. This implies 60 technical replicates were used for the statistical calculation of CVs for each level.
- Data Provenance: The data was generated internally by Instrumentation Laboratory Company, in their labs, using "specific lots of IL reagents on IL instrumentation." The country of origin is implicitly the United States, where the company is located. The study is prospective in the sense that it was conducted specifically to evaluate the performance of this new calibrator.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the device is an in vitro diagnostic calibrator. "Ground truth" for this device is defined by its manufacturing specifications and metrological traceability, not by expert interpretation. The "truth" is the assigned value of the calibrator.
4. Adjudication method for the test set
Not applicable for a precision study of an in vitro diagnostic calibrator.
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 device is an in vitro diagnostic calibrator, not an AI/ML-driven diagnostic system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept does not apply to this device. The calibrator itself does not have an "algorithm" or "standalone performance" in the context of AI/ML. Its performance is measured by its precision and ability to establish a calibration curve.
7. The type of ground truth used
The "ground truth" for a calibrator is its assigned value, which is established through a rigorous process of metrological traceability, typically against international reference materials or methods. The document does not detail how the absolute 'Mean IU/mL' values (-0.03, 0.47, 0.80) were assigned, but it's understood to be part of the product's manufacturing and assay development process, following established metrological principles for calibrators.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
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Section 3 Calibration Plasma LMW Heparin - 510(k) Summary (Summary of Safety and Effectiveness)
Submitted by:
Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02421 Phone: 781-861-4467 781-861-4207 Fax:
Contact Person:
Carol Marble. Regulatory Affairs Director Phone: 781-861-4467 / Fax: 781-861-4207
Summary Prepared:
March 26, 2003
Name of the devices:
Calibration Plasma LMW Heparin
Classification names:
| Common Name | Primary Calibrator |
|---|---|
| Product Code | JIS |
| Regulation Number | 862.1150 |
| Classification | Class II |
Identification of predicate devices:
K002400 Assess Calibration Plasma
This calibration plasma 510(k) cleared as part of analyzer systems, NOTE: most recently the ACL Advance.
Description of the device/intended uses:
Calibration Plasma LMW Heparin is an in vitro diagnostic product intended as a tri-level calibrator to prepare calibration curves for use in chromogenic heparin assays.
Statement of Technological Characteristics of the Device Compared to Predicate Devices:
The new Calibration Plasma LMW Heparin is substantially equivalent in intended use and performance with heparin assays to the predicate calibrator: Assess Calibration Plasma.
Summary of Performance Data:
A precision study was performed with Calibration Plasma LMW Heparin (tri-level) over multiple days with multiple runs (n=60) using specific lots of IL reagents on IL instrumentation:
| Description | MeanIU/mL | Within Run%CV | Between Run%CV | Total%CV |
|---|---|---|---|---|
| Level 1 | -0.03 | 0.018 (SD) | 0.008 (SD) | 0.024 (SD) |
| Level 2 | 0.47 | 2.99 | 1.47 | 4.24 |
| Level 3 | 0.80 | 2.21 | 0.00 | 2.58 |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized representation of a human figure, with three overlapping profiles suggesting a sense of community or interconnectedness. The text "DEPARTMENT OF HEALTH • HUMAN SERVICES • USA" is arranged in a circular pattern around the figure, emphasizing the organization's name and national affiliation.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Carol Marble Regulatory Affairs Manager Instrumentation Laboratory Company 101 Hartwell Avenue Lexington, Massachusetts 02421-3125
Re: K030964
Trade/Device Name: Calibration Plasma LMW Heparin Regulation Number: 21 CFR § 862.1150 Regulation Name: Calibrator Regulatory Class: II Product Code: JIS, KFF Dated: May 19, 2003 Received: May 30, 2003
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.
JUN - 6 2003
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 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.
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Page 2 -
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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 Putman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Calibration Plasma LMW Heparin Device Name:
Indications for Use:
Calibration Plasma LMW Heparin is an in vitro diagnostic product intended as a tri-level calibrator to prepare calibration curves for use in chromogenic heparin assays.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Division Sign-Off | |
|---|---|
Office of In Vitro Diagnostic Device
Evaluation and Safety
| 510(k) | K030964 |
|---|---|
| Prescription Use(Per 21 CFR 801.019) | OR Over-The-Counter Use |
Section 2
: 上
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.