(71 days)
Not Found
No
The document describes a calibration plasma for laboratory assays and does not mention any AI/ML components or image processing.
No
This device is described as an in vitro diagnostic product intended as a calibrator for laboratory assays, not for direct therapeutic use on patients.
Yes
The device is explicitly stated as an "in vitro diagnostic product" in both the "Intended Use / Indications for Use" and "Device Description" sections.
No
The device is described as an "in vitro diagnostic product" and a "tri-level calibrator," which are physical substances used in laboratory testing, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "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."
This statement clearly identifies the device as an in vitro diagnostic product.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
JIS, KFF
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 | Mean
IU/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 |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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 | Mean
IU/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 |
1
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
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