(34 days)
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No
The document describes a quality control material for hematology analyzers and does not mention any AI or ML components.
No
This device is a quality control material used to monitor the performance of hematology analyzers, not to treat patients or medical conditions.
No
This device is a quality control material used to monitor the performance of hematology analyzers, not a device that directly diagnoses a patient's condition.
No
The device description clearly states it is a "reference product prepared from treated, stabilized human erythrocytes in an isotonic, bacteriostatic medium," indicating it is a physical material, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that it is a "hematology quality control material used to monitor the performance of COULTER hematology analyzers." Quality control materials used to assess the performance of diagnostic instruments fall under the definition of IVDs.
- Device Description: The description details the composition of the material, which is designed to simulate blood components for testing on hematology analyzers. This further supports its role in the diagnostic process.
- Predicate Device: The mention of a predicate device (K912133; COULTER® 5C® Cell Control) which was "Cleared as COULTER® PX Cell Control" indicates that this type of product has been previously reviewed and cleared by regulatory bodies as an IVD.
N/A
Intended Use / Indications for Use
5C 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 (Refer to your Product Manuals or On-line Help System.)
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.
Product codes (comma separated list FDA assigned to the subject device)
JPK
Device Description
5C Cell Control is a reference product prepared from treated, stabilized human erythrocytes in an isotonic, bacteriostatic medium. 5C Cell Control also contains a stabilized, platelet-sized component, and fixed erythrocytes to simulate leukocytes. By design, 5C Cell Control confirms and monitors instrument accuracy and precision performance by providing measurements for counting, sizing, hemoglobin determination and White Blood Cell differentiation using VCS technology.
Mentions image processing
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Mentions AI, DNN, or ML
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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 studies of 5C Cell Control with RDW-SD parameter support the Beckman Coulter stability claims of 13 events within 13 days (open vial) and 95 days (closed vial).
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).
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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.
0
K 060464
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 running through it. To the right of the circle are the words "BECKMAN" on the top line and "COULTER" on the bottom line, both in a bold, sans-serif font.
MAR 2 8 2006
510(k) Summary Parameter Addition (RDW-SD) to COULTER 5C Cell Control
1. 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. Date Submitted:
February 21, 2006
3. Device Name(s):
3.1 Proprietary Names
COULTER® 5C® Cell Control
3.2 Classification Name
Hematology quality control mixture (21 CFR § 864.8625)
4. Predicate Device:
| Candidate(s) | Predicate | Manufacturer | Docket
Number |
|------------------------------|--------------------------------------------------------------------------|-----------------------|------------------|
| COULTER® 5C® Cell
Control | COULTER® 5C® Cell
Control
(Cleared as COULTER® PX
Cell Control) | Beckman Coulter, Inc. | K912133 |
5. Description:
5C Cell Control is a reference product prepared from treated, stabilized human erythrocytes in an isotonic, bacteriostatic medium. 5C Cell Control also contains a stabilized, platelet-sized component, and fixed erythrocytes to simulate leukocytes. By design, 5C Cell Control confirms and monitors instrument
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) 526-69321 (800) 327-6531 (305) 380-3800 Internet: www.beckmancouiter.com
1
accuracy and precision performance by providing measurements for counting, sizing, hemoglobin determination and White Blood Cell differentiation using VCS technology.
ి. Intended Use:
5C 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 (Refer to your Product Manuals or On-line Help System.)
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 5C Cell Control with the additional parameter (RDW-SD) is identical to the current COULTER 5C Cell Control. RDW-SD is a derived parameter from the RBC histogram which is obtained on a new COULTER hematology analyzer (5106 submission pending). The control product formulation and manufacturing processes were not modified to obtain the additional parameter.
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 5C Cell Control with RDW-SD parameter support the Beckman Coulter stability claims of 13 events within 13 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 implementing regulation 21 CFR 807.92.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing and tail. The eagle is positioned to the right of a circular inscription that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
MAR 2 8 2000
Food and Drug Administratio 2098 Gaither Road Rockville MD 20850
Ms. Nancy Nadler Staff Regulatory Affairs Specialist Beckman Coulter, Inc. 11800 SW 147 Avenue, M/C: 31-B06 Miami, Florida 33196-2500
K060464 Trade/Device Name: COULTER® 5C® Cell Control Regulation Number: 21 CFR § 864.8625 Regulation Name: Hematology quality control mixture Regulatory Class: II Product Code: JPK Dated: February 21, 2006 Received: February 22, 2006
Dear Ms. Nadler:
Re:
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 (OS) 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 Beckerh
Robert L. Becker, Jr., MD, PK Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
page 1 of
510(k) Number (if known):
Device Name: COULTER® 5C® Cell Control
Indications for Use:
5C 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 (Refer to your Product Manuals or On-line Help System.)
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(per 21 CFR 801.109)
OR
Over-the-Counter Use
Optional Format 1-2-96
Division Sign Off
Office of In Vitro Diagnostic Device
Evaluation and Safety
510(k) K060464
Concurrence of CDRH, Office of Device Evaluation (ODE)