(69 days)
No
The description focuses on a quality control mixture for hematology analyzers and does not mention any AI or ML components.
No.
The device is an in vitro diagnostic control used to monitor the performance of laboratory equipment, not to treat or diagnose a medical condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "For In Vitro Diagnostic Use". Although it is a control substance, its purpose is to monitor the performance of diagnostic instruments, which is a crucial part of ensuring accurate diagnostic results.
No
The device description explicitly states it is a "Hematology Quality Control Mixture" prepared from "stabilized erythrocytes and a red chromophore," indicating it is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "COULTER® ALT TRON Cell Control is intended For In Vitro Diagnostic Use as a control to monitor the performance of the CBC parameters on COULTER® A · T Series Systems."
This statement clearly indicates that the device is intended for use in vitro (outside of the body) for diagnostic purposes, which is the definition of an IVD.
N/A
Intended Use / Indications for Use
COULTER® AST TRON Cell Control is intended For In Vitro Diagnostic Use as a control to monitor the performance of the CBC parameters on the COULTER® A . T Series Systems. Instrument performance is monitored using the assigned ranges on the TABLE OF EXPECTED RESULTS and reagents designed by Coulter for these systems.
Product codes
JPK
Device Description
The product is a Hematology Quality Control Mixture which like the predicate device, COULTER® 4C® PLUS Cell Control, is used to monitor the performance of Coulter hematology analyzers. COULTER® A °T TRON Cell Control is prepared from stabilized erythrocytes and a red chromophore so that repeated measurements can be made to monitor daily performance of the instrument system. Assigned values are confirmed by multiple analyses of the control product.
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
Nonclinical testing focused on performance characteristics of homogeneity and stability. Testing met all acceptance criteria for the following: precision tested by replicate measurements and stability tested by recovery of values within the Assigned Ranges (Table of Expected Results on the package insert).
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
h)
510(k) Summary COULTER® AºT TRON Cell Control
JUN 30 1997
Date of Summary:
Coulter Corporation, Company/Institution name: 11800 SW 147 Ave. Miami, FL 33196, Mailcode 31-B06 Thomas J. English, Phone 1-305-380-4331 Contact Name:
April 16, 1997
Common or usual name or classification name: Hematology Quality Control Mixture COULTER® A . T TRON Cell Control Product name: 864.8625 C.F.R. Section: Device Class: Class II
510(k) numbers of Coulter devices to which substantial equivalence is claimed: COULTER® 4C® PLUS Cell Control, K964988
The product is a Hematology Quality Control Mixture which like the predicate device, COULTER® 4C® PLUS Cell Control, is used to monitor the performance of Coulter hematology analyzers. COULTER® A °T TRON Cell Control is prepared from stabilized erythrocytes and a red chromophore so that repeated measurements can be made to monitor daily performance of the instrument system. Assigned values are confirmed by multiple analyses of the control product.
Intended Use: COULTER® AST TRON Cell Control is intended For In Vitro Diagnostic Use as a control to monitor the performance of the CBC parameters on the COULTER® A . T Series Systems. Instrument performance is monitored using the assigned ranges on the TABLE OF EXPECTED RESULTS and reagents designed by Coulter for these systems.
COULTER A . T TRON Cell Control has the same intended use as the predicate device. Both devices are used to monitor instrument performance. Both devices consist of stabilized erythrocytes and a platelet-sized component suspended in a bacteriostatic medium. Both have assigned values which are confirmed by multiple analyses of the control product.
The differences between COULTER A T TRON cell control and COULTER 4C PLUS Cell Controls are: COULTER A T TRON cell control utilizes a red chromophore measured spectrophotometrically to simulate hemoglobin. COULTER A . T TRON cell control monitors the lytic reagent but does not monitor the potency of the lytic reagent. The predicate device in the presence of lytic reagent forms a Met-Hgb complex which is measured spectrophotometrically. COULTER 4C PLUS Cell Control monitors both the volume and potency of the lytic reagent.
Nonclinical testing focused on performance characteristics of homogeneity and stability. Testing met all acceptance criteria for the following: precision tested by replicate measurements and stability tested by recovery of values within the Assigned Ranges (Table of Expected Results on the package insert).
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. The text is written in a simple, sans-serif font.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Thomas J. Enqlish Director, Regulatory Affairs Coulter Corporation P.O. Box 169015 Miami, Florida 33116-9015
JUN 30 1997
K971469 Re: COULTER® A°.T Tron Cell Control Requlatory Class: II Product Code: . JPK Dated: April 18, 1997 Received: April 22, 1997
Dear Mr. English:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual reqistration, 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Requlations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 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.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".
Sincerely yours,
Steven Sitman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE
510(k) Number (if known): N/A
Device Name: COULTER®ALT TRON Cell Control
Indications For Use:
more TER® A · T TRON Cell Control is intended For In Vitro Diagnostic Use as a control to monitor the performance of the CBC parameters on COULTER® A · T Series Systems. Instrument performance is monitored using the assigned ranges on the TABLE OF EXPECTED RESULTS and reagents designed by Coulter for these systems.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_L (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Form 1-2-96)
Patricia A. Bernhardt,
(for Awm) 6/26/97
K97449