(208 days)
6C Cell Control is a hematology quality control material used to monitor the performance of COULTER hematology analyzers listed in the TABLE OF EXPECTED RESULTS in conjunction with specific COULTER reagents.
The assigned values and expected ranges on the TABLE OF EXPECTED RESULTS can be used to monitor instrument performance. This product can also be used to establish your own laboratory mean.
6C Cell Control is a reference product prepared from treated, stabilized human erythrocytes in an isotonic medium. 6C Cell Control also contains a stabilized, platelet-sized component, and fixed erythrocytes to simulate leukocytes and nucleated red blood cells. By design, 6C Cell Control confirms and monitors instrument accuracy and precision performance by providing measurements for counting, sizing, hemoglobin determination, NRBC enumeration and White Blood Cell differentiation using VCSn technology.
The provided text describes a 510(k) submission for the COULTER® 6C Cell Control, a hematology quality control material. It primarily focuses on the device's description, intended use, and comparison to predicate devices, along with the FDA's clearance letter. However, the document does not contain the detailed information necessary to fully answer all aspects of your request, particularly regarding specific acceptance criteria values, a formal study report with detailed performance metrics, sample sizes for test sets, expert qualifications, or MRMC comparative effectiveness studies.
Based on the information available in the provided text, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list specific numerical acceptance criteria (e.g., specific ranges for recovery, precision targets). It generally states that the device is used to "monitor instrument accuracy and precision performance" and that "assigned values and expected ranges on the TABLE OF EXPECTED RESULTS can be used to monitor instrument performance."
The primary performance data reported is related to stability:
| Performance Metric | Acceptance Criteria (Inferred from reported data) | Reported Device Performance |
|---|---|---|
| Stability (Open Vial) | To support 18 days of stability | 18 days |
| Stability (Closed Vial) | To support 95 days of stability | 95 days |
Note: The document states, "The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to products already in commercial distribution." However, it does not provide the specific data points that demonstrate this. The stability data is the only concrete performance metric mentioned in this summary.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" sample size or data provenance (e.g., country of origin, retrospective/prospective). The studies mentioned are "Stability studies," but details about the number of runs, samples, or instruments involved are not provided in this summary.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided. For a quality control material, the "ground truth" would likely be established through reference methods or highly calibrated instruments, rather than expert interpretation.
4. Adjudication Method for the Test Set
This information is not provided and is generally not applicable for a quality control material where performance is assessed against established targets or reference values, rather than subjective interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was done or mentioned. This type of study is more relevant for diagnostic imaging or interpretation devices where human readers are involved. The 6C Cell Control is a quality control material used to monitor instrument performance.
6. Standalone Performance Study
The "Summary of Performance Data" refers to "Stability studies." These studies would be considered standalone performance assessments of the control material itself, demonstrating its ability to maintain stable parameters over time. However, the details of these studies are not provided in this document. The device's primary function is to monitor the performance of an analyzer, so its "standalone" performance relates to its internal stability.
7. Type of Ground Truth Used
For a quality control material like the COULTER® 6C Cell Control, the ground truth for parameters like cell counts, sizing, and hemoglobin would most likely be established through:
- Reference Methods: Highly accurate, often manual or specialized, laboratory methods.
- Assigned Values: Values derived from extensive testing on reference instruments, often by the manufacturer, and subsequently printed on the product's "TABLE OF EXPECTED RESULTS."
- Calibration Standards: Traceability to primary calibration standards.
The document states, "The assigned values and expected ranges on the TABLE OF EXPECTED RESULTS can be used to monitor instrument performance." This implies that the "ground truth" for the device's expected values is based on these assigned values.
8. Sample Size for the Training Set
The document does not mention a "training set." This concept is typically applicable to AI/machine learning models. The 6C Cell Control is a physical control material, not a software algorithm that requires training data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this device.
In summary, the provided document is a 510(k) summary focused on demonstrating substantial equivalence to a predicate device and confirming basic stability. It does not contain the detailed study reports or performance data that would typically be found in a full scientific publication or a more comprehensive regulatory submission for a novel diagnostic device.
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Image /page/0/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a circular graphic on the left and the company name on the right. The graphic is a black circle with two curved white lines inside. The company name is written in a bold, sans-serif font, with "BECKMAN" on top of "COULTER".
l
JAN 21 2009
510(k) Summary COULTER 6C Cell Control
l Submitted By:
Lourdes Coba Staff Regulatory Affaırs Specialıst Beckman Coulter, Inc 11800 SW 147 Avenue, M/C 31-B06 Mıamı, Florıda 33196-2500 Telephone (305) 380-4191 FAX (305) 380-4344
2 Date Submitted:
June 26, 2008
3 Device Name(s):
3 1 Proprietary Names
COULTER® 6C Cell Control
3 2 Classification Name
Hematology qualıty control mıxture (21 CFR § 864 8625)
4 Predicate Device:
| Candidate(s) | Predicate | Manufacturer | DocketNumber |
|---|---|---|---|
| COULTER® 6C CellControl | COULTER® 5C®Cell Control(Cleared asCOULTER® PX CellControl) | Beckman Coulter, Inc | K912133&K060464 |
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5 Description:
.
て
6C Cell Control is a reference product prepared from treated, stabilized human erythrocytes in an isotonic medium 6C Cell Control also contains a stabilized, platelet-sized component, and fixed erythrocytes to simulate leukocytes and nucleated red blood cells By design, 6C Cell Control confirms and monitors instrument accuracy and precision performance by providing measurements for counting, sizing, hemoglobin determination, NRBC enumeration and White Blood Cell differentiation using VCSn technology
6 Intended Use:
6C Cell Control is a hematology quality control material used to monitor the performance of COULTER hematology analyzers listed in the TABLE OF EXPECTED RESULTS in conjunction with specific COULTER reagents
The assigned values and expected ranges on the TABLE OF EXPECTED RESULTS can be used to monitor instrument performance This product can also be used to establish your own laboratory mean
7 Comparison to Predicate(s):
COULTER 6C Cell Control is essentially identical to the current COULTER 5C Cell Control with the addition of 2 parameters NRBC% and NRBC# This control 1s for use with the UniCel® DxH 800 analyzer (pending 510(k) submission) An NRBC analog was added to the 5C control product formulation
8 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 6C Cell Control support the Beckman Coulter stability claims of 18 events within 16 days (open vial) and 95 days (closed vial)
This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementung 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 and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Beckman Coulter, Inc c/o Ms Nancy Nadler Staff Regulatory Affairs Specialist 11800 SW 147" Avenue Miamı, FL 33196
JAN 21 2009
Re K081822
Trade/Device Name Coulter® 6C Cell Control Regulation Number 21 CFR 864 8625 Regulation Name Hematology Quality Control Mixture Regulatory Class Class II Product Code 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 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 comples 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 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 Otfice of Surveillance and Biometric's (OSB's) Division of Postmarket Survey)lance 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 us Internet address http //www fda gov/cdrh/industry/support/index.html
Sincerely yours,
M chan
Maria M Chan, Ph D Acting Division Director 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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510(k) Number (if known) K
ીસ જિલ્લામાં આવેલું એક ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપા
Device Name COULTER® 6C Ccll Control
Indications For Use
6C Cell Control is a hematology quality control material used to monitor the performance of COULTER hematology analyzers Insted in the TABLE OF EXPECTED RESULTS In conjunction with specific COULTER reagents
The assigned values and expected ranges on the TABLE OF EXPECTED RESULTS can be used to montor instrument performance This product can also be used to establish your own laboratory mean
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 CDRH Office of In Vitro Diagnostic Devices (OIVD)
ision Sign Off
Office of In Vitro Diagnostic Design
Page 1 of
Office of In Vitro Diagnostic Device Evaluation and Sa
5.19(k) K081822
COULTER® 6C Cell Control Traditional 510(k) Notification
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§ 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.