(71 days)
No
The device is a quality control material for laboratory assays and the summary does not mention any AI/ML components.
No.
This device is described as an "in vitro diagnostic quality control material" used to assess precision and accuracy of chromogenic heparin assays, not to treat, diagnose, or prevent disease in a patient.
No
The device is described as an "in vitro diagnostic quality control material" used to assess the precision and accuracy of chromogenic heparin assays, not to diagnose a patient's condition directly.
No
The device is described as an "in vitro diagnostic quality control material," which is a physical substance used to verify the performance of a diagnostic test. This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "Control Plasma LMW Heparin is an in vitro diagnostic quality control material..."
This statement clearly identifies the device as an in vitro diagnostic product.
N/A
Intended Use / Indications for Use
Control Plasma LMW Heparin is an in vitro diagnostic quality control material intended for use with chromogenic heparin assays to assess precision and accuracy at heparin low and high levels.
Product codes
GGN, KFF
Device Description
Control Plasma LMW Heparin is an in vitro diagnostic quality control material intended for use with chromogenic heparin assays to assess precision and accuracy at heparin low and high levels.
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
A precision study was performed with Control Plasma LMW Heparin (Low and High Levels) 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% |
|-------------|---------------|-------------------|--------------------|--------------|
| Low Level | 0.42 | 3.81 | 1.70 | 4.65 |
| High Level | 0.75 | 2.26 | 0.71 | 3.34 |
Key Metrics
| Description | Mean
IU/mL | Within Run
%CV | Between Run
%CV | Total
CV% |
|-------------|---------------|-------------------|--------------------|--------------|
| Low Level | 0.42 | 3.81 | 1.70 | 4.65 |
| High Level | 0.75 | 2.26 | 0.71 | 3.34 |
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Section 3 Control 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 device:
Control Plasma LMW Heparin
Classification names:
| Common Name | Plasma, Coagulation Control |
|---|---|
| Product Code | GGN |
| Regulation Number | 864.5425 |
| Classification | Class II |
Identification of predicate devices:
K002400 Assess Low and High Heparin Controls NOTE: These control levels were 510(k) cleared as part of analyzer systems. most recently the ACL Advance.
Description of the device/intended uses:
Control Plasma LMW Heparin is an in vitro diagnostic quality control material intended for use with chromogenic heparin assays to assess precision and accuracy at heparin low and high levels.
Statement of Technological Characteristics of the Device Compared to Predicate Devices:
Control Plasma LMW Heparin is substantially equivalent in intended use to the predicate controls: Assess Low and High Heparin Controls.
Summary of Performance Data:
A precision study was performed with Control Plasma LMW Heparin (Low and High Levels) 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% |
|-------------|---------------|-------------------|--------------------|--------------|
| Low Level | 0.42 | 3.81 | 1.70 | 4.65 |
| High Level | 0.75 | 2.26 | 0.71 | 3.34 |
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 & Human Services. The logo features a stylized image of an eagle with three heads, each slightly offset from the other. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" surrounding the top half of the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN - 6 2003
Regulatory Affairs Manager Instrumentation Laboratory Company 101 Hartwell Avenue Lexington, Massachusetts 02421-3125
Re: K030965
Ms. Carol Marble
Trade/Device Name: Control Plasma LMW Heparin Regulation Number: 21 CFR § 864.5425 Regulation Name: Multipurpose System for in vitro coagulation studies Regulatory Class: II Product Code: GGN, 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.
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.
2
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 Sutman
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
3
Indications for Use Statement
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Control Plasma LMW Heparin
Indications for Use:
Control Plasma LMW Heparin is an in vitro diagnostic quality control material intended for use with chromogenic heparin assays to assess precision and accuracy at heparin low and high levels.
(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) | K030965 |
|---|---|
| -------- | --------- |
| Prescription Use
| (Per 21 CFR 801.019) | OR | Over-The-Counter Use | ||
|---|---|---|---|---|
| ------------------------------------------ | -------------------------------------------- | ---- | ---------------------- | -- |