(219 days)
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
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
The provided text is a 510(k) summary for the COULTER® LIN-X Linearity Controls. It does not contain the specific details required to complete all sections of your request regarding acceptance criteria and a study demonstrating device performance. The document generally states that studies were conducted but does not provide the quantitative results or methodologies in detail.
Here's an attempt to answer your questions based on the available information, noting where information is missing:
1. A table of acceptance criteria and the reported device performance
The document states: "Stability, calibration assessment, value assignment and range determination studies were conducted and demonstrate acceptable performance per manufacturing specifications." However, specific acceptance criteria and the numerical results of the reported device performance are not provided in this summary. It only indicates that performance was "acceptable."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Demonstrated acceptable performance per manufacturing specifications |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide information on:
- The sample size used for any test set.
- The data provenance (e.g., country of origin) or whether the studies were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The document relates to linearity controls for hematology analyzers, not a diagnostic device requiring expert interpretation for ground truth. Ground truth for linearity controls typically involves reference methods and established ranges. Therefore, this question is not applicable in the context of this device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
As this is a linearity control product and not a device requiring human interpretation of results, an adjudication method for a "test set" in the traditional sense is not applicable. The performance is assessed against established ranges and manufacturing specifications.
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
This is a linearity control product, not an AI-assisted diagnostic device that would involve human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a control product used to assess the calibration of an analyzer. Its performance is inherent in its chemical and biological properties (stability, assigned values). It is not an algorithm, so a "standalone" algorithm-only performance study in that sense is not applicable. The performance studies likely focused on the control material itself within the context of the analyzer.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For linearity controls, the "ground truth" (or "expected results") is typically established through:
- Reference methods: Highly accurate and precise methods, often manual or semi-automated, used to determine the true concentration of analytes (WBC, RBC, HGB, PLT) in each control level.
- Value assignment: Through rigorous testing on multiple calibrated instruments and comparison to reference materials or methods, a consensus true value (or an expected range) is established for each control level over its shelf life.
The document refers to "established expected range" and "manufacturing specifications," implying use of such methods.
8. The sample size for the training set
The document does not provide information on the sample size for any "training set." Linearity controls are not machine learning models that require a training set in the typical sense. Performance is likely validated through extensive manufacturing runs, stability studies, and evaluation on target instruments.
9. How the ground truth for the training set was established
As the concept of a "training set" for a linearity control device is not applicable, the establishing of ground truth for such a set is also not applicable.
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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 | DocketNumber |
|---|---|---|---|
| COULTER® LIN-XLinearity Control | COULTER® LIN-C®Linearity Control(Cleared asCOULTER®Linearity Controls) | Beckman Coulter, Inc | K955334andK061064 |
| CBC-LineHematology LinearityKit (for calibrationassessment only) | R&D Systems | K942822 |
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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
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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
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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
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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
§ 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.