(30 days)
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.
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.
Acceptance Criteria and Study for COULTER® LIN-C® Linearity Control (K061064)
This submission describes the COULTER® LIN-C® Linearity Control, a device intended to verify the reportable range of COULTER hematology analyzers. The primary focus of this 510(k) is on the additional levels of this control covering an extended cellular component range. Therefore, the "device" in question refers to these additional levels of the linearity control.
The document does not explicitly state specific numerical acceptance criteria for the device's performance. Instead, it relies on the concept of "substantial equivalence" to a predicate device. The performance data section broadly states: "The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to products already in commercial distribution."
However, the nature of a linearity control implies certain performance characteristics, primarily stability and the ability to accurately represent the linearity of the analytical system within its reportable range.
1. Table of Acceptance Criteria and Reported Device Performance
Given the lack of explicit quantitative acceptance criteria in the provided document, we infer the criteria based on the device's function and the summary provided.
| Acceptance Criterion (Inferred) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device | The additional levels of COULTER LIN-C linearity controls are "essentially identical" to the current COULTER LIN-C linearity controls (K955334), with the exception of the additional levels covering an extended cellular component range and the analyzers on which it may be used. |
| Stability (Open Vial) | Supports claims of 7 open vial days. |
| Stability (Closed Vial) | Supports claims of 120 closed vial days. |
| Verification of Reportable Range | Intended to verify the reportable range of COULTER hematology analyzers. (Performance data implicitly supports this through the substantial equivalence claim). |
| Safety and Effectiveness | "Supports a finding of substantial equivalence to products already in commercial distribution." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It simply states "data in the Premarket Notification on safety and effectiveness."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This type of device (a quality control mixture) does not typically involve human experts establishing "ground truth" in the way an imaging device or diagnostic test might. Instead, the "ground truth" for a linearity control would be established by reference methods or highly calibrated instruments. The document does not provide any information on the number or qualifications of experts involved in establishing ground truth, as it's not directly applicable in the conventional sense for this product.
4. Adjudication Method
Not applicable for this type of device. The performance of a linearity control is assessed through objective measurements on hematology analyzers, not through human interpretation or adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. MRMC studies are typically performed for devices where human readers interpret results (e.g., medical imaging). This device is a quality control material, not a diagnostic interpretation tool for human readers.
6. Standalone Performance Study
Yes, a standalone performance study was implicitly done to support the stability claims and demonstrate substantial equivalence. The "Summary of Performance Data" states: "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 indicates direct testing of the control material's stability characteristics. The overall "safety and effectiveness" data also falls under standalone performance, as it pertains to the device itself.
7. Type of Ground Truth Used
The "ground truth" for a linearity control would involve measurements obtained from calibrated reference instrumentation or validated methods against which the control material's behavior is compared to ensure it performs as expected across the analytical range. The document does not explicitly state the specific type of ground truth, but for linearity controls, it would generally be analytical measurements using established and accurate laboratory techniques.
8. Sample Size for the Training Set
The document does not provide information on the sample size for a training set. This is likely because the development of a linearity control involves formulation and characterization rather than a typical machine learning "training" process.
9. How the Ground Truth for the Training Set Was Established
Not applicable in the typical sense of a "training set" for an algorithm. The ground truth for the development and characterization of the linearity control would have been established through extensive laboratory testing using validated methodologies and reference materials to accurately determine the expected values and stability characteristics across its intended range.
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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 | DocketNumber |
|---|---|---|---|
| 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
§ 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.