(30 days)
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No
The summary describes a linearity control for hematology analyzers, which is a standard laboratory control material. There is no mention of AI, ML, or any related technologies in the intended use, device description, or performance studies.
No
The device is a linearity control intended to verify the reportable range of hematology analyzers, not to treat or diagnose patients.
No
The device is a linearity control, which is used to verify the reportable range of hematology analyzers, not to diagnose medical conditions in patients. It's a quality control material, not a diagnostic tool for patients.
No
The device description explicitly states that the device is composed of "stabilized human blood components," indicating it is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the controls are "intended to verify the reportable range of COULTER hematology analyzers... in conjunction with specific COULTER reagents." This indicates the device is used to assess the performance of other diagnostic devices (hematology analyzers and reagents) in a laboratory setting.
- Device Description: The description states that the controls are "stabilized human blood components from which repeated measurements are made to verify the reportable range of Beckman Coulter hematology systems." This confirms that the device is a reagent or material used in a laboratory test (hematology analysis) to evaluate the performance of the testing system.
- Predicate Device: The predicate device listed (K955334; COULTER® LIN-C® Linearity Control) is also a linearity control for hematology analyzers, which are typically classified as IVDs.
These points strongly indicate that the COULTER LIN-C linearity controls are used in vitro (outside the body) to perform diagnostic-related functions (verifying the performance of diagnostic equipment).
N/A
Intended Use / Indications for Use
COULTER LIN-C linearity controls are intended to verify the reportable range of COULTER hematology analyzers listed in the TABLE OF EXPECTED RESULTS in conjunction with specific COULTER reagents. Refer to your Product Manuals or On-line Help System.
Product codes (comma separated list FDA assigned to the subject device)
JPK
Device Description
LIN-C linearity controls are stabilized human blood components from which repeated measurements are made to verify the reportable range of Beckman Coulter hematology systems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to products already in commercial distribution. Stability studies of COULTER LIN-C linearity controls support the Beckman Coulter stability claims of 7 open vial days and 120 closed vial days.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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
§ 864.8625 Hematology quality control mixture.
(a)
Identification. A hematology quality control mixture is a device used to ascertain the accuracy and precision of manual, semiautomated, and automated determinations of cell parameters such as white cell count (WBC), red cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).(b)
Classification. Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
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Image /page/0/Picture/1 description: The image shows the logo for Beckman Coulter. The logo consists of a stylized black circle with two white curved lines inside, resembling a stylized eye or a wave pattern. To the right of the circle, the words "BECKMAN" and "COULTER" are stacked on top of each other in a bold, sans-serif font.
! " ・ ・
510(k) Summarv Additional Levels of COULTER® LIN-C® Linearity Controls
1.0 Submitted By:
Nancy Nadler Staff Regulatory Affairs Specialist Beckman Coulter, Inc. 11800 SW 147 Avenue, M/C: 31-B06 Miami, Florida 33196-2500 Telephone: (305) 380-4191 FAX: (305) 380-3618
2.0 Date Submitted:
April 14, 2006
3.0 Device Name(s):
Proprietary Names 3.1
COULTER® LIN-C® Linearity Control
3.2 Classification Name
Hematology quality control mixture (21 CFR § 864.8625)
4.0 Predicate Device:
| Candidate(s) | Predicate | Manufacturer | Docket
Number |
|--------------------------------------|-------------------------------------------------------------------------------------|-----------------------|------------------|
| COULTER® LIN-C®
Linearity Control | COULTER® LIN-C®
Linearity Control
(Cleared as COULTER®
Linearity Controls) | Beckman Coulter, Inc. | K955334 |
5.0 Description:
LIN-C linearity controls are stabilized human blood components from which repeated measurements are made to verify the reportable range of Beckman Coulter hematology systems.
Beckman Coulter , Inc. 11800 S.W. 147th Avenue Miami, FL 33196-2500
Mailing Address: 11800 S.W. 147th Avenue P.O. Box 169015 Miami, FL 33116-9015
Customer Service: (800) 526-7694 Product Information: (800) 526-6932 (800) 327-6531 (305) 380-3800 Internet: www.beckmancoulter.com
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6.0 Intended Use:
COULTER LIN-C linearity controls are intended to verify the reportable range of COULTER hematology analyzers listed in the TABLE OF EXPECTED RESULTS in conjunction with specific COULTER reagents. Refer to your Product Manuals or On-line Help System.
7.0 Comparison to Predicate(s):
The additional levels of COULTER LIN-C linearity controls are essentially identical to the current COULTER LIN-C linearity controls with the exception of the additional levels covering an extended cellular component range and the analyzers on which it may be used.
8.0 Summary of Performance Data:
The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to products already in commercial distribution. Stability studies of COULTER LIN-C linearity controls support the Beckman Coulter stability claims of 7 open vial days and 120 closed vial days.
This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of an eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Nancy Nadler Staff Regulatory Affairs Specialist Beckman Coulter, Inc. 11800 SW 147 Avenue, M/S: 31-B06 Miami, Florida 33196-2500
MAY 1 7 2006
ﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ
K061064 Re:
Trade/Device Name: COULTER® LIN-C® Linearity Control Regulation Number: 21 CFR § 864.8625 Regulation Name: Hematology quality control mixture Regulatory Class: II Product Code: JPK Dated: April 14, 2006 Received: April 17, 2006
Dear Ms. Nadler:
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.
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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 (240) 276-0484. 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/industry/support/index.html
Sincerely yours,
Robert L. Becker, Jr., MD, PHD Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K061064
Device Name: COULTER® LIN-C® Linearity Control
Indications For Use: COULTER LIN-C linearity controls are intended to verify the reportable range of COULTER hematology analyzers listed in the TABLE OF EXPECTED RESULTS in conjunction with specific COULTER reagents. Refer to your Product Manuals or On-line Help System.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Robert Bodef
Division Sign-Off
Page 1 of 1
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K061064