(197 days)
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No
The document mentions a "VCS Technology algorithm" for calculating MRV, but there is no mention of AI, ML, or related terms, nor is there any description of training or test sets which are typical for AI/ML models. The focus is on demonstrating substantial equivalence to predicate devices using traditional statistical methods.
No.
The device is an in vitro diagnostic (IVD) hematology analyzer used to quantify and classify blood components, which provides diagnostic information rather than treating or preventing disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that it is "For In Vitro Diagnostic Use in clinical laboratories," and later describes it as a "device used to identify and classify one or more of the formed elements of blood," which are characteristics of a diagnostic device.
No
The device is described as a quantitative, automated hematology analyzer, which is a hardware system that performs laboratory tests on blood samples. While it utilizes software for analysis (VCS Technology algorithm), it is fundamentally a hardware device with integrated software, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "For In Vitro Diagnostic Use in clinical laboratories."
N/A
Intended Use / Indications for Use
The COULTER hematology analyzers with IRF and MRV parameters are quantitative, automated hematology analyzers and leukocyte differential counters intended For In Vitro Diagnostic Use in clinical laboratories. These systems also provide automated Reticulocyte analysis.
The COULTER GEN S System with IRF and MRV Parameters is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The COULTER GEN-S System also provides automated Reticulocyte analysis.
Product codes (comma separated list FDA assigned to the subject device)
81GKZ
Device Description
The Immature Reticulocyte Fraction expresses the number of early reticulocytes as a proportion of the total reticulocyte count. Mean reticulocyte volume (MRV) is the average cell volume of the reticulocytes, determined by the VCS Technology algorithm and is reported in femtoliters (fL).This 510(k) Premarket Notification provides information demonstrating that Coulter hematology analyzers with IRF and MRV parameters are substantially equivalent to products previously cleared for this use. The COULTER hematology analyzers with IRF and MRV parameters are compared to Sysmex™ hematology analyzers with the IRF parameter. The MRV parameter is presented as a discussion of the calculation and supported by precision data from a COULTER GEN-S System analyzer. Unlike the Sysmex R-1000, R-3000 and RAM-1 analyzers which are dedicated to the measurement of reticulocyte parameters, the COULTER hematology analyzers, including the GEN.S, measure multiple CBC and differential parameters in addition to the measurement of reticulocyte parameters.
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
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
clinical laboratories.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to hematology analyzers already in commercial distribution. Equivalence is demonstrated through compared sample accuracy and imprecision experiments.
1RF Accuracy Analysis : GEN•S vs Sysmex SE9500
PARAMETER: IRF
UNITS: Not Applicable
POPULATION MEAN Predicate Method: 0.199
POPULATION MEAN Comparator Method: 0.391
MEAN DIFFERENCE: -0.192
SD OF DIFFERENCE: 0.07953
SLOPE: 0.835
Y-INTERCEPT: 0.225
R: 0.757
N: 332
IRF and MRV Paired Imprecision results: GEN.S
| IRF | MRV | |
|---|---|---|
| Units | Not Applicable | Femtoliters (fL) |
| N | 90 | 90 |
| Population Minimum | 0.127 | 93.6 |
| Population Maximum | 0.372 | 123.2 |
| Mean difference | 0 | 0.04 |
| S.D. of Difference | 0.04 | 2.33 |
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.
Sysmex™ w/IRF Parameter (K971736/S1), COULTER® GEN-S™ System (K962988), COULTER® New Methylene Blue Prep Retic MAXM/AL Analyzers (K925344)
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).
Not Found
§ 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
Summary of Safety & Effectiveness COULTER® Hematology Analyzers with IRF & MRV Parameters
Submitted By 1.0
Stan Sugrue, Ph.D. Senior Requlatory Affairs Specialist Coulter Corporation 11800 SW 147 Avenue MC 31-B06 Miami. FL 33196 Telephone: (305) 380-4552 FAX: (305) 380-3618
APR 2, 0 2000
2.0 Date Submitted
March 28, 2000
3.0 Device Name(s)
3.1 Proprietary Names
COULTER® Hematology Analyzers with IRF & MRV Parameters
3.2 Classification Names
The product is classified as a Class III device as found in 21CFR 864.5220.
An automated differential cell counter is a device used to identify and classify one or more of the formed elements of blood. (CFR 864.5220) . The Classification Number is 81GKZ.
4.0 Predicate Device(s)
Sysmex™ w/IRF Parameter (K971736/S1), COULTER® GEN-S™ System (K962988), COULTER® New Methylene Blue Prep Retic MAXM/AL Analyzers (K925344)
5.0 Description
The Immature Reticulocyte Fraction expresses the number of early reticulocytes as a proportion of the total reticulocyte count. Mean reticulocyte volume (MRV) is the average cell volume of the reticulocytes, determined by the VCS Technology algorithm and is reported in femtoliters (fL).This 510(k) Premarket Notification provides information demonstrating that Coulter hematology analyzers with IRF and MRV parameters are substantially equivalent to products previously cleared for this use. The COULTER hematology analyzers with IRF and MRV parameters are compared to Sysmex™ hematology analyzers with the IRF parameter. The MRV parameter is presented as a discussion of the calculation and supported by precision data from a COULTER GEN-S System analyzer. Unlike the Sysmex R-1000, R-3000 and RAM-1 analyzers which are dedicated to the measurement of reticulocyte parameters, the COULTER hematology analyzers, including the GEN.S, measure multiple CBC and differential parameters in addition to the measurement of reticulocyte parameters.
6.0 Intended Use
The COULTER hematology analyzers with IRF and MRV parameters are quantitative, automated hematology analyzers and leukocyte differential counters intended For In Vitro Diagnostic Use in clinical laboratories. These systems also provide automated Reticulocyte analysis.
7.0 Comparison to Predicate(s):
The following table show the basic similarities and differences between the COULTER® GEN-S and predicate device(s).
1
SIMILARITIES TO THE PREDICATE
| COULTER hematology analyzers with IRF and MRV parameters | Sysmex SE & R Series |
|---|---|
| Systems provide automated reticulocyte analysis | Same |
| Report IRF parameter | Same* |
*Reported as sum of MFR (Middle Fluorescence Ratio) and HFR (High Fluorescence Ratio)
DIFFERENCES FROM THE PREDICATE:
| COULTER hematology analyzers with IRF and MRV
| parameters | Sysmex R Series |
|---|---|
| Quantitative, automated hematology analyzers and leukocyte | |
| differential counters | Measures reticulocyte parameters only |
| Report MRV parameters | No MRV analysis |
| Measure CBC, 5-part differential and reticulocyte parameters | Measures reticulocyte parameters only |
| Use impedance for counting and sizing RBCs and platelets | No RBC or platelet analysis |
| Reticulocyte parameters derived from laser light scatter and | |
| nucleic acid dye (New Methylene Blue) | Reticulocyte parameters are measured by |
| fluorescence and light scatter utilizing a | |
| fluorescent dye (Auramine-O) |
8.0 Summary of Performance Data:
The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to hematology analyzers already in commercial distribution. Equivalence is demonstrated through compared sample accuracy and imprecision experiments.
| PARAMETER | IRF |
|---|---|
| UNITS | Not Applicable |
| POPULATION MEAN | |
| Predicate Method | 0.199 |
| POPULATION MEAN | |
| Comparator Method | 0.391 |
| MEAN DIFFERENCE | -0.192 |
| SD OF DIFFERENCE | 0.07953 |
| SLOPE | 0.835 |
| Y-INTERCEPT | 0.225 |
| R | 0.757 |
| N | 332 |
1RF Accuracy Analysis : GEN•S vs Sysmex SE9500
IRF and MRV Paired Imprecision results: GEN.S
| IRF | MRV | |
|---|---|---|
| Units | Not Applicable | Femtoliters (fL) |
| N | 90 | 90 |
| Population Minimum | 0.127 | 93.6 |
| Population Maximum | 0.372 | 123.2 |
| Mean difference | 0 | 0.04 |
| S.D. of Difference | 0.04 | 2.33 |
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.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines forming its wings and body.
APR 2 0 2000
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Stan Sugrue, Ph.D. Senior Regulatory Affairs Specialist Coulter Corporation 11800 SW 147 Avenue MC 31-B06 Miami, Florida 33196
Re: K993356
Trade Name: COULTER® Hematology Analyzers with IRF & MRV Parameters Regulatory Class: III Product Code: GKZ Dated: March 28, 2000 Received: March 29, 2000
Dear Dr. Sugrue:
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 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements 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 regulations.
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Page 2
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 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 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
4
INDICATIONS FOR USE
993356 510(k) Number (if known):
COULTER Hematology Analyzers with IRF and MRV Parameters Device:
Indications For Use:
The COULTER GEN S System with IRF and MRV Parameters is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The COULTER GEN-S System also provides automated Reticulocyte analysis.
21 CFR 864.5220 Automated differential cell counter
An automated differential cell counter is a device used to identify and classify one or more of the formed elements of blood.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Retu E. Maún
(Division Sign-Off)
Division of Clinical Laboratory Devices K993356
510(k) Number.
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Form 1-2-96)