(42 days)
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No
The description focuses solely on antibody reagents for flow cytometry and does not mention any computational analysis or algorithms that would suggest AI/ML.
No
The device is a diagnostic reagent used for identifying and enumerating lymphocyte percentages in whole blood by flow cytometry, not for treating a condition.
Yes
The device is used to identify and enumerate specific lymphocyte percentages in whole blood, which are biological markers that can be used to monitor health conditions or disease progression, fitting the definition of a diagnostic device.
No
The device is described as a "triple-color murine monoclonal antibody reagent" used in flow cytometry. This indicates a physical reagent, not a software-only device.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the reagents are used to "identify and enumerate the percentages of total CD19+, total CD3+, total CD8+, and dual CD3+/CD8+ lymphocytes in whole blood by flow cytometry." This process involves testing a sample (whole blood) taken from the human body to provide information about a person's health status.
- Sample Type: The device is used with "whole blood," which is a biological specimen.
- Method: The method used is "flow cytometry," which is a common technique in clinical laboratories for analyzing cells.
These characteristics align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
IQ Prep Reagent CD45 FITC/ CD19 R-PE/ CD3 CyQ is a triple-color murine monoclonal antibody reagent used to identify and enumerate the percentages of total CD19+ and total CD3+ lymphoctyes in whole blood by flow cytometry. To monitor for any non-specific staining, the isotypic control IQ Prep Reagent CD45 FITC/ IgG1 R-PE/IgG1 CyQ may be used.
IQ Prep Reagent CD45 FITC/ CD8 R-PE/ CD3 CyQ is a triple-color murine monoclonal antibody reagent used to identify and enumerate the percentages of total CD8+, and dual CD3+/CD8+ lymphoctyes in whole blood by flow cytometry. To monitor for any non-specific staining, the isotypic control IQ Prep Reagent CD45 FITC/ IgG1 R-PE/ IgG1 CyQ may be used.
IQ Prep Reagent CD45 FITC/ CD4 R-PE/ CD3 CyQ is a triple-color murine monoclonal antibody reagent used to identify and enumerate the percentages of total CD3 positive, total CD4 positive, and dual CD3 positive lymphoctyes in whole blood by flow cytometry. To monitor for any non-specific staining, the isotypic control IQ Prep Reagent CD45 FITC/ IgG1 R-PE/ IgG1 CyQ is used.
IQ Prep Reagent CD45 FITC/IgG1 R-PE/IgG1 CyQ is a triple-color murine monoclonal antibody reagent used to monitor the level of nonspecific antibody binding in cell surface staining procedures that use the other IQ Prep Reagents are comprised of the monoclonal antibody to CD45, that is labeled with the fluorochrome FITC, and two other IgG1 subclass monoclonal antibodies that are conjugated to either PE or CyQ fluorochromes.
Product codes (comma separated list FDA assigned to the subject device)
GKZ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
flow cytometry
Anatomical Site
whole blood
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
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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.
Not Found
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.
Not Found
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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§ 864.5220 Automated differential cell counter.
(a)
Identification. An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.(b)
Classification. Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.”
0
Image /page/0/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.
DEPARTMENT OF HEALTH & HUMAN SERVICES
IO Corporation . c/o Harold G. Haines, Ph.D. President South Florida BioAssociates, Inc. 11511 SW 127th Street Miami, Florida 33176
od and Drug Administratio 098 Gaither Road Rockville MD 20850
K022528 Re:
Trade/Device Name: IQ Products Triple-Color Flow Cytometry Reagents IO Prep Reagent CD45 FITC/CD4 R-PE/CD3 CyQ IQ Prep Reagent CD45 FITC/CD8 R-PE/CD3 CyQ IQ Prep Reagent CD45 FITC/CD19 R-PE/CD3 CyQ IQ Prep Reagent CD45 FITC/IgG1 R-PE/IgG1 CyQ Regulation Number: 21 CFR § 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: II Product Code: GKZ Dated: July 2, 2002 Received: July 31, 2002
Dear Dr. Haines:
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2
This Jetter 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 regulation (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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
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
2
Page 1 of 4
510(k) Number (if known): K022528
Device Name:
IQ Prep Reagent CD45 FITC/ CD19 R-PE/ CD3 CyQ.
Indications For Use:
IQ Prep Reagent CD45 FITC/ CD19 R-PE/ CD3 CyQ is a triple-color murine monoclonal antibody reagent used to identify and enumerate the percentages of total CD19+ and total CD3+ Iymphoctyes in whole blood by flow cytometry.
To monitor for any non-specific staining, the isotypic control IQ Prep Reagent CD45 FITC/ IgG1 R-PE/IgG1 CyQ may be used.
Jevheni Bautski
Division Sigh-Off Division of Clinical Laboratory Devices 510(k) Number-
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format) 1-2-96
3
.
510(k) Number (if known): K022528
Device Name:
IQ Prep Reagent CD45 FITC/ CD8 R-PE/ CD3 CyQ
Indications For Use:
IQ Prep Reagent CD45 FITC/ CD8 R-PE/ CD3 CyQ is a triple-color murine monoclonal antibody reagent used to identify and enumerate the percentages of total CD8+, and dual CD3+/CD8+ lymphoctyes in whole blood by flow cytometry.
To monitor for any non-specific staining, the isotypic control IQ Prep Reagent CD45 FITC/ IgG1 R-PE/ IgG1 CyQ may be used.
Josephine Briutati
on of Clinical I aboratory I 510(k) Number.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
4
.
.
1974
510(k) Number (if known): K022528
:
:
Device Name:
. '
.
IQ Prep Reagent CD45 FITC/ CD4 R-PE/ CD3 CyQ
Indications For Use:
IQ Prep Reagent CD45 FITC/ CD4 R-PE/ CD3 CyQ is a triple-color murine monoclonal antibody reagent used to identify and enumerate the percentages of total CD3 positive, total CD4 positive, and dual CD3 positive lymphoctyes in whole blood by flow cytometry. To monitor for any non-specific staining, the isotypic control IQ Prep Reagent CD45 FITC/ IgG1 R-PE/ IgG1 CyQ is used.
| (Division Sign-Off) | |
|---|---|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K022528 |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per CFR 801.109)
✓
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
OR
5
Page 4 of 4
510(k) Number (if known): K022528
Device Name:
IQ Prep Reagent CD45 FITC/IgG1 R-PE/IgG1 CyQ
Indications For Use:
IQ Prep Reagent CD45 FITC/IgG1 R-PE/IgG1 CyQ is a triple-color murine monoclonal antibody reagent used to monitor the level of nonspecific antibody binding in cell surface staining procedures that use the other IQ Prep Reagents are comprised of the monoclonal antibody to CD45, that is labeled with the fluorochrome FITC, and two other IgG1 subclass monoclonal antibodies that are conjugated to either PE or CyQ fluorochromes.
Chrystine Bratki
(Division Sidn Division of Clinical Laboratory Devices 510(k) Number
:
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per CFR 801.109)
OR
Over-The-Counter Use
(Optional Format) 1-2-96