(187 days)
None
No
The document describes a quality control material for a hematology analyzer, not a device that processes data or images using AI/ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No
This device is a quality control material used to monitor the performance of a hematology analysis system, not to directly treat or diagnose a medical condition in a patient.
No
The device is a quality control material used to monitor the performance of a diagnostic system, not to diagnose a condition in a patient directly.
No
The device description clearly states it is a "reference product prepared from treated, stabilized human erythrocytes suspended in an isotonic 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 it's a "hematology quality control material used to monitor the performance and verify the measuring range of the body fluid cycle of the UniCel® DxH 800 COULTER Cellular Analysis System." This indicates it's used in vitro (outside the body) to assess the performance of a diagnostic instrument.
- Device Description: It's a "reference product prepared from treated, stabilized human erythrocytes suspended in an isotonic medium." This describes a material used for testing or calibration in a laboratory setting.
- Predicate Device: The mention of predicate devices (K912133 & K060464; COULTER® 5C® Cell Control) which are also quality control materials for hematology analyzers, further supports its classification as an IVD. Quality control materials for diagnostic instruments are considered IVDs.
Therefore, based on the provided information, the Body Fluid Control is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Body Fluid Control is a hematology quality control material used to monitor the performance and verify the measuring range of the body fluid cycle of the UniCel® DxH 800 COULTER Cellular Analysis System. Refer to the System HELP or Instructions for Use.
The assigned values and expected ranges on the TABLE OF EXPECTED RESULTS can be used to monitor performance, and verify the measurable range. This product can also be used to establish your own laboratory mean.
Product codes
JPK
Device Description
Body Fluid Control is a reference product prepared from treated, stabilized human erythrocytes suspended in an isotonic medium. Body Fluid Control also contains a stabilized, platelet-sized component, and fixed erythrocytes to simulate leukocytes. Body Fluid Control confirms and monitors instrument accuracy and precision performance by providing measurements during counting.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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 Body Fluid Control support the Beckman Coulter stability claims of 18 events within 16 days (open vial) and 120 days (closed vial).
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
FEB - 3 2009
510(k) Summary COULTER® Body Fluid Control
1. Submitted By:
Lourdes Coba Staff Regulatory Affairs Specialist Beckman Coulter, Inc. 11800 SW 147 Avenue, M/C: 31-B06 Miami, Florida 33196-2500 Telephone: (305) 380-4079 FAX: (305) 380-4344
2. Date Submitted:
July 30, 2008
3. Device Name(s):
.
3:1 Proprietary Names
COULTER® Body Fluid Control
3.2 Classification Name
Hematology quality control mixture (21 CFR § 864.8625)
4. Predicate Device:
| Candidate(s) | Predicate | Manufacturer | Docket
Number |
|--------------------------------|-----------------------------------------------------------------------------|-----------------------|-------------------------|
| COULTER® Body
Fluid Control | COULTER® 5C®
Cell Control
(Cleared as
COULTER® PX Cell
Control) | Beckman Coulter, Inc. | K912133
&
K060464 |
COULTER® Body Fluid Control Traditional 510(k) Notification
Page 16
... . . -----------------
1
5. Description:
Body Fluid Control is a reference product prepared from treated, stabilized human erythrocytes suspended in an isotonic medium. Body Fluid Control also contains a stabilized, platelet-sized component, and fixed erythrocytes to simulate leukocytes. Body Fluid Control confirms and monitors instrument accuracy and precision performance by providing measurements during counting.
Intended Use: 6.
Body Fluid Control is a hematology quality control material used to monitor the performance and verify the measuring range of the body fluid cycle of the UniCel® DxH 800 COULTER Cellular Analysis System. Refer to the System HELP or Instructions for Use.
The assigned values and expected ranges on the TABLE OF EXPECTED RESULTS can be used to monitor performance, and verify the measurable range. This product can also be used to establish your own laboratory mean.
7. Comparison to Predicate(s):
COULTER Body Fluid Control is similar to the current COULTER 5C Cell Control except for the number of parameters reported and their respective concentrations. The product is used to monitor the RBC and TNC (white blood cells) measurements from the Body Fluid cycle on the UniCel® DxH 800 analyzer (pending 510(k) clearance K081930).
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 Body Fluid Control support the Beckman Coulter stability claims of 18 events within 16 days (open vial) and 120 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
Image /page/2/Picture/1 description: The image shows a circular seal with text around the perimeter and a symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The central symbol appears to be an abstract representation, possibly of an eagle or other bird-like figure, with three stylized wing or feather shapes.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Beckman Coulter, Inc. c/o Ms. Lourdes Coba Staff Regulatory Affairs Specialist 11800 SW 147th Avenue Miami, FL 33196
FEB -3 2009
Re: K082162
Trade/Device Name: Coulter® Body Fluid Control Regulation Number: 21 CFR 864.8625 Regulation Name: Hematology Quality Control Mixture Regulatory Class: Class II Product Code: JPK Dated: January 06, 2009 Received: January 07, 2009
Dear Ms. Coba:
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 - Ms. Lourdes Coba
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 Biometric'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,
Maria 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
4
Indications for Use
510(k) Number (if known):
Device Name: COULTER® Body Fluid Control
Indications For Use:
Body Fluid Control is a hematology quality control material used to monitor the performance and verify the measuring range of the body fluid cycle of the UniCel® DxH 800 COULTER Cellular Analysis System. Refer to the System HELP or Instructions for Use.
The assigned values and expected ranges on the TABLE OF EXPECTED RESULTS can be used to monitor performance, and verify the measurable range. 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) |
|---|
| Page 1 of 1. |
| Office of |
| Evaluation |
| K082162 |
COULTER® Body Fluid Control Traditional 510(k) Notification
Page 14