(219 days)
Not Found
No
The document describes a linearity control for cellular analysis systems, which is a stabilized blood component used for calibration and verification. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies focus on stability and calibration assessment, not algorithmic performance.
No
The device is described as a linearity control intended to assess calibration and verify the reportable range of cellular analysis systems, not to diagnose, treat, or prevent disease.
No
Explanation: The device, COULTER LIN-X linearity controls, is used to assess calibration and verify the reportable range of COULTER cellular analysis systems, not to diagnose a disease or condition in a patient. It is a control material for instruments.
No
The device is described as stabilized human blood components, indicating it is a physical control material, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the controls are used to "assess calibration and verify the reportable range of COULTER cellular analysis systems listed in the TABLE OF EXPECTED RESULTS in conjunction with specific COULTER reagents". This indicates the device is used in vitro (outside the body) to evaluate the performance of other diagnostic devices (the cellular analysis systems and reagents).
- Device Description: The description mentions that the controls are "stabilized human blood components" and that "Results from repeated measurements for each concentration are compared to the established expected range to assess the instrument's calibration and verify the reportable range". This further confirms that the device is a reagent or control used in a laboratory setting to assess the accuracy and performance of diagnostic tests.
- Predicate Devices: The listed predicate devices (COULTER® LIN-C® Linearity Control and CBC-Line Hematology Linearity Kit) are also IVD controls used for similar purposes in hematology analysis.
Therefore, based on the intended use, device description, and the nature of the predicate devices, the COULTER LIN-X linearity controls are clearly intended for use in an in vitro diagnostic setting.
N/A
Intended Use / Indications for Use
COULTER LIN-X linearity controls are intended to assess calibration and verify the reportable range of COULTER cellular analysis systems listed in the TABLE OF EXPECTED RESULTS in conjunction with specific COULTER reagents
Product codes (comma separated list FDA assigned to the subject device)
JPK
Device Description
COULTER LIN-X linearity controls are stabilized human blood components whose WBC, RBC, HGB, and PLT concentrations span the instrument's reportable range Results from repeated measurements for each concentration are compared to the established expected range to assess the instrument's calıbration and verify the reportable range
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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)
Stability, calibration assessment, value assignment and range determination studies were conducted and demonstrate acceptable performance per manufacturing specifications The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to products already ın commercial distribution
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.
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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.
0
KOR16411
JAN 1 6 2009
510(k) Summary COULTER® LIN-X Linearity Controls
1 0 Submitted By:
Nancy Nadler Staff Regulatory Affairs Specialist Beckman Coulter, Inc 11800 S W 147 Avenue M/S 31-B06 Mıamı, Florıda 33196-2500 (305) 380-4191 Telephone FAX (305) 380-3618
20 Date Submitted:
June 6, 2008
30 Device Name(s):
- Proprietary Names 3 1
COULTER® LIN-X 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-X
Linearity Control | COULTER® LIN-C®
Linearity Control
(Cleared as
COULTER®
Linearity Controls) | Beckman Coulter, Inc | K955334
and
K061064 |
| | CBC-Line
Hematology Linearity
Kit (for calibration
assessment only) | R&D Systems | K942822 |
1
50 Description:
ﺰﻛﺮ
COULTER LIN-X linearity controls are stabilized human blood components whose WBC, RBC, HGB, and PLT concentrations span the instrument's reportable range Results from repeated measurements for each concentration are compared to the established expected range to assess the instrument's calıbration and verify the reportable range
୧ 0 Intended Use:
COULTER LIN-X linearity controls are intended to assess calibration and verify the reportable range of COULTER cellular analysis systems listed in the TABLE OF EXPECTED RESULTS in conjunction with specific COULTER reagents Refer to your Product Manuals or On-Iıne Help System
70 Comparison to Predicate(s):
COULTER LIN-X linearity controls are essentially identical to the current COULTER LIN-C linearity controls with the exception of an additional level covering an extended cellular component range, the analyzers on which it may be used and an expanded intended use for calibration assessment
80 Summary of Performance Data:
Stability, calibration assessment, value assignment and range determination studies were conducted and demonstrate acceptable performance per manufacturing specifications The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to products already ın commercial distribution
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
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of an eagle.
Food and Drug Administration 2098 Garther Road Rockville MD 20850
JAN 1 6 2009
Beckman Coulter, Inc c/o Ms Nancy Nadler Staff Regulatory Affairs Specialist 11800 SW 147th Avenue Miami, FL 33196
Re K081641 Trade/Device Name Coulter® LIN-X Linearity Control Regulation Number 21 CFR 864 8625 Regulation Name Hematology Quality Control Mixture Regulatory Class Class II Product Code JPK Dated January 05, 2009 Received January 06, 2009
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
3
Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807 97) For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Brometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474 For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464 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 (240) 276-3150 or at its Internet address http //www fda gov/cdrh/industry/support/index.html
Sincerely yours.
m chan
Maria M Chan, Ph D Acting Dıvısıon Dırector Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known) K081641
Device Name COULTER® LIN-X Linearity Control
Indications For Use COULTER LIN-X Innearity controls are intended to assess calibration and verify the reportable range of COULTER cellular analysis systems listed in the TABLE OF EXPECTED RESULTS in conjunction with specific COULTER reagents Research and THE your Product Manuals or On-line Help System
Prescription Use __ X_ (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 CDRH2 Office of Vitro Daagnostic Devices (OIVD) Page 1 of 1 Office of In Vitro Diagnostic Device Evaluation and Safety
COULTER® LIN-X Linearity Controls Traditional 510(k) Notification
Page 14