(245 days)
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No
The document describes "digital image processing" for counting cells, which is a standard image analysis technique and does not inherently imply the use of AI or ML. There is no mention of AI, ML, or related terms like deep learning or neural networks.
No
The device is used for diagnostic purposes by quantifying cells in cerebrospinal fluid, not for treating or preventing a disease.
Yes
The device is intended to provide quantitation of fluorescence labeled total nucleated cells and erythrocytes in cerebrospinal fluid, which helps in the diagnosis or monitoring of medical conditions.
No
The device description explicitly lists multiple hardware components as part of the system, including the Instrument, Computer (hardware & software), Vacuum Station, Sample Preparation Tray, Barcode Reader, Pipettes, and Test Cartridge.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "quantitation of fluorescence labeled total nucleated cells and erythrocytes in cerebrospinal fluid collected from adult and pediatric patients." This is a diagnostic measurement performed on a biological sample (cerebrospinal fluid) to provide information about a patient's health status.
- Device Description: The device description details a system that uses reagents to stain cells in a sample and then counts them using imaging. This process is performed in vitro (outside the body) on a biological specimen.
- Clinical Laboratories: The intended user is "trained healthcare professionals in clinical laboratories," which is a typical setting for IVD devices.
- Performance Studies: The document includes detailed performance studies (Accuracy, Repeatability, Precision/Reproducibility, Linearity, etc.) which are standard requirements for demonstrating the analytical performance of an IVD device.
- Controls: The mention of "Low and High Level Controls" further supports its IVD nature, as controls are used to monitor the performance of diagnostic tests.
- Predicate Device: The inclusion of a predicate device (Sysmex XN-10) with a K number indicates that this device is being compared to a previously cleared IVD device.
All of these factors align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The GloCyte Automated Cell Counter System is intended for use by trained healthcare professionals in clinical laboratories to provide quantitation of fluorescence labeled total nucleated cells and erythrocytes in cerebrospinal fluid collected from adult and pediatric patients.
The GloCyte Low and High Level Controls are assayed hematology controls designed to monitor the performance of the GloCyte Automated Cell Counter System. Assayed parameters include total nucleated cells and erythrocytes.
Product codes (comma separated list FDA assigned to the subject device)
GKL, JPK
Device Description
The GloCyte® Automated Cell Counter System is an automated cell counter that concentrates and enumerates total nucleated cells (TNCs) and red blood cells (RBCs) using fluorescent microscopy and digital image analysis principles. The test method uses one of two reagents to stain TNCs (propidium iodide with detergent) or RBCs (fluorochrome labeled anti- human RBC antibody in buffer with stabilizers), and a digital imaging system to count the cells. The image is captured by a digital CCD camera, and the fluorescent stained cells are counted via digital image processing.
The GloCyte® Automated Cell Counter System includes the Instrument, Computer (hardware & software), Vacuum Station, Sample Preparation Tray, Barcode Reader, Pipettes (10 and 30 µL), Test Cartridge, TNC and RBC Reagents, Low and High Level Controls.
Mentions image processing
digital image analysis principles.
The image is captured by a digital CCD camera, and the fluorescent stained cells are counted via digital image processing.
Mentions AI, DNN, or ML
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Input Imaging Modality
Fluorescent microscopy/digital imaging system
Anatomical Site
cerebrospinal fluid
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
trained healthcare professionals in clinical laboratories
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)
Accuracy
Study Type: Method comparison studies, established according to CLSI EP09 Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline-Third Edition (2013).
Sample Size:
TNC: Pediatric N=129, Adult N=223
RBC: Pediatric N=196, Adult N=267
Data Source: clinical and contrived CSF specimens
Key Results: Results were shown to meet acceptance criteria.
Repeatability
Study Type: Repeatability study
Data Source: clinical and manipulated CSF specimens as well as GloCyte® Low and High Level Controls.
Key Results: The results of the repeatability study met acceptance criteria.
Precision/Reproducibility
Study Type: Reproducibility study
Data Source: GloCyte® Low and High Level Controls for both RBC and TNC parameters.
Key Results: The results of the precision study met acceptance criteria.
Linearity
Study Type: Linearity study established according to CLSI EP6-A Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline (2003).
Data Source: Contrived RBC and TNC CSF samples, created by dilution of human blood cells into blank CSF
Sample Size: Studies conducted on three GloCyte® Automated Cell Counter Systems.
Key Results: Pooled data from the three GloCyte® Automated Cell Counter Systems demonstrate that there is a linear relationship between the measured GloCyte and the expected values for TNC and RBC counts in the ranges shown in table 5-6.
Determination of limit of blank, limit of detection, limit of quantitation and reportable range
Study Type: LoB, LoD, and LoQ determined according to CLSI EP17-A2 Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline-Second Edition (2012).
Key Results: The LoQ, combined with the linear range, was used to determine the reportable range.
TNC Reportable Range: 3 – 6,500 cells/µL
RBC Reportable Range: 2 – 615,644 cells/µL
Interfering Substances
Study Type: Interference testing
Key Results: Table 5-8 lists potential interferents tested and the test results, indicating concentrations at which no interference was observed for various substances.
Quality Control Stability
Study Type: Closed vial (shelf life) stability study
Key Results: Preliminary stability claim of 7 months when stored at 2-8°C.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy (Hemocytometer vs. GloCyte TNC and RBC counts):
TNC Pediatric: Slope 0.963 (0.909, 1.000), Intercept 0.037 (0.000, 0.182), Constant Bias none, Proportional Bias none
TNC Adult: Slope 1.000 (1.000, 1.003), Intercept 0.000 (-0.003, 0.000), Constant Bias none, Proportional Bias none
RBC Pediatric: Slope 0.910 (0.885, 0.935), Intercept 0.000 (-0.045, 0.058), Constant Bias none, Proportional Bias -9%
RBC Adult: Slope 1.000 (0.986, 1.007), Intercept 0.000 (0.000, 0.015), Constant Bias none, Proportional Bias none
Repeatability (%CV Results):
TNC (4 - 10,313 cells/uL): 2.5 - 18.0 %CV
RBC (5 - 727,800 cells/uL): 2.7 - 16.3 %CV
Reproducibility (%CV):
TNC Low (Mean 10.6 cells/µL): Within-Run 10.1, Between-Run 0.0, Between-Day 1.6, Between-Site 3.9, Between-Operator 2.4, Total 11.2
TNC High (Mean 122.9 cells/µL): Within-Run 5.9, Between-Run 0.0, Between-Day 0.0, Between-Site 3.1, Between-Operator 1.5, Total 6.9
RBC Low (Mean 11.3 cells/µL): Within-Run 9.2, Between-Run 0.0, Between-Day 1.9, Between-Site 3.8, Between-Operator 2.7, Total 10.5
RBC High (Mean 130.0 cells/µL): Within-Run 5.3, Between-Run 0.0, Between-Day 0.7, Between-Site 1.7, Between-Operator 1.0, Total 5.7
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 XN-10, (K112605)
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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§ 864.5200 Automated cell counter.
(a)
Identification. An automated cell counter is a fully-automated or semi-automated device used to count red blood cells, white blood cells, or blood platelets using a sample of the patient's peripheral blood (blood circulating in one of the body's extremities, such as the arm). These devices may also measure hemoglobin or hematocrit and may also calculate or measure one or more of the red cell indices (the erythrocyte mean corpuscular volume, the mean corpuscular hemoglobin, or the mean corpuscular hemoglobin concentration). These devices may use either an electronic particle counting method or an optical counting method.(b)
Classification. Class II (performance standards).
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 27, 2016
Advanced Instruments, Inc. Mr. Robert Mello Vice President and Chief Operating Officer Two Technology Way Norwood, MA 02062
Re: K152776 Trade/Device Name: GloCyte® Automated Cell Counter System GloCyte® Low and High Level Controls Regulation Number: 21 CFR 864.5200 Regulation Name: Automated cell counter Regulatory Class: Class II Product Code: GKL, JPK Dated: April 26, 2016 Received: April 27, 2016
Dear Mr. Mello:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
1
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Leonthena R. Carrington -S
Leonthena R. Carrington, MS, MBA, MT(ASCP) Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K152776
Device Name GloCyte Automated Cell Counter System
GloCyte Low and High Level Controls
Indications for Use (Describe)
The GloCyte Automated Cell Counter System is intended for use by trained healthcare professionals in clinical laboratories to provide quantitation of fluorescence labeled total nucleated cells and erythrocytes in cerebrospinal fluid collected from adult and pediatric patients.
The GloCyte Low and High Level Controls are assayed hematology controls designed to monitor the performance of the GloCyte Automated Cell Counter System. Assayed parameters include total nucleated cells and erythrocytes.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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5.1 Applicant
Advanced Instruments, Inc. Two Technology Way Norwood, MA 02062 USA Phone: 781-320-9000 Fax: 617-845-9032
Date: September 24, 2015
Contact Person: Robert Mello Vice President and Chief Operating Officer Phone: 781-471-2008 Fax: 781-320-8181
5.2 Device
Trade name: GloCyte® Automated Cell Counter System Common Name: Automated Cell Counter Panel: 81 Hematology Regulation: 21 CFR 864.5200- Automated Cell Counter Product Code: GKL Class II
Trade name: GloCyte® Low and High Level Controls Common Name: Hematology quality control mixture Panel: 81 Hematology 21 CFR 864.8625 - Hematology quality control mixture Product Code: JPK Class II
5.3 Predicate Device
Sysmex XN-10, (K112605)
5.4 Device Description
The GloCyte® Automated Cell Counter System is intended for use by trained healthcare professionals in clinical laboratories to provide quantitative determination of fluorescence labeled total nucleated cells and erythrocytes in cerebrospinal fluid collected from adult and pediatric patients.
The GloCyte® Automated Cell Counter System is an automated cell counter that concentrates and enumerates total nucleated cells (TNCs) and red blood cells (RBCs) using fluorescent
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510(k) Summary for
Glocyte® Automated Cell Counter System and Glocyte® Low and High Level Controls
microscopy and digital image analysis principles. The test method uses one of two reagents to stain TNCs (propidium iodide with detergent) or RBCs (fluorochrome labeled anti- human RBC antibody in buffer with stabilizers), and a digital imaging system to count the cells. The image is captured by a digital CCD camera, and the fluorescent stained cells are counted via digital image processing.
The GloCyte® Automated Cell Counter System includes the Instrument, Computer (hardware & software), Vacuum Station, Sample Preparation Tray, Barcode Reader, Pipettes (10 and 30 µL), Test Cartridge, TNC and RBC Reagents, Low and High Level Controls.
5.5 Intended Use
The GloCyte® Automated Cell Counter System is intended for use by trained healthcare professionals in clinical laboratories to provide quantitative determination of fluorescence labeled total nucleated cells and erythrocytes in cerebrospinal fluid collected from adult and pediatric patients.
The GloCyte® Low and High Level Controls are assayed hematology controls designed to monitor the performance of the GloCyte® Automated Cell Counter System. Assayed parameters include total nucleated cells and erythrocytes.
5.6 Substantial Equivalence
A comparison of similarities and differences between the GloCyte® Automated Cell Counter System and the predicate device is provided in table 5-1(Similarities) and 5-2 (Differences).
| Table 5-1. Substantial Equivalence Table Comparing GloCyte® Automated Cell Counter | ||
|---|---|---|
| System to Predicate Device: Similarities |
| Items | Predicate: Sysmex XN-10 | GloCyte® Automated Cell Counter System |
|---|---|---|
| SIMILARITIES | ||
| Sample Type | CSF (and other body fluids) | Cerebrospinal fluid (CSF) |
| Hardware | Flow system, semiconductor laser with optical components. | Semiconductor laser with optical components. |
| Parameter(s) | WBC-BF#, RBC-BF# | TNC, RBC |
| Items | Predicate: Sysmex XN-10 | GloCyte® Automated Cell Counter System |
| DIFFERENCES | ||
| Intended Use | The XN-Series modules (XN-10, XN-20) are quantitative multi-parameter | |
| automated hematology analyzers | ||
| intended for in vitro diagnostic use in | ||
| screening patient populations found in | ||
| clinical laboratories. The XN-Series | ||
| modules classify and enumerate the | ||
| following parameters in whole blood: | ||
| WBC, RBC, HGB, HCT, MCV, MCH, | ||
| MCHC, PLT, NEUT%/#, LYMPH%/#, | ||
| MONO%/#, EO%/#, BASO%/#, | ||
| IG%/#, RDW-CV, RDW-SD, MPV, | ||
| NRBC#/%, RET%/#, IPF, IRF, RET- | ||
| He and has a Body Fluid mode for body | ||
| fluids. The Body Fluid mode | ||
| enumerates the WBC-BF, RBC-BF, | ||
| MN%/#, PMN%/#, and TC-BF | ||
| parameters in cerebrospinal fluid (CSF), | ||
| serous fluids (peritoneal, pleural) and | ||
| synovial fluids. Whole blood should be | ||
| collected in K2 or K3EDTA | ||
| anticoagulant and, Serous and Synovial | ||
| fluids in K2EDTA anticoagulant to | ||
| prevent clotting of fluid. The use of | ||
| anticoagulants with CSF specimens is | ||
| neither required nor recommended. | The GloCyte® Automated Cell | |
| Counter System is intended for use by | ||
| trained healthcare professionals in | ||
| clinical laboratories to provide | ||
| quantitative determination of | ||
| fluorescence labeled total nucleated | ||
| cells and erythrocytes in cerebrospinal | ||
| fluid collected from adult and | ||
| pediatric patients. | ||
| Test Principles | Performs hematology analysis | |
| according to the Hydro Dynamic | ||
| Focusing (DC Detection), flow | ||
| cytometry method (using a | ||
| semiconductor laser), and SLS- | ||
| hemoglobin method. | Detection of fluorescence from stained | |
| RBCs/TNCs using semiconductor laser | ||
| and optical system to analyze, | ||
| calculate and display cell counts. | ||
| Reagents | LYSERCELL WDF (Lyse) | |
| FLUOROCELL WDF (Stain) | ||
| CELLPACK™ DCL (Diluent) | ||
| CELLPACK™ DFL (Diluent) | TNC Reagent (hemolysis of RBCs & | |
| stain nucleated cells) | ||
| RBC Reagent (anti-human glycophorin | ||
| A/B antibody fluorescent stain). | ||
| Calibrators | XN-10 Calibrator (XN CAL) | No external calibrator |
| Sample/Fluidic Pathway | Single fluidic pathway | No fluidic pathway |
| Dimensions of | ||
| Main Unit | Width: 645mm | |
| Height: 855mm | ||
| Depth: 755mm | ||
| (Single Unit including Sampler) | Width: 153mm | |
| Height: 255mm | ||
| Depth: 204mm | ||
| (Instrument) | ||
| Width: 121mm | ||
| Height: 108mm | ||
| Depth: 108mm | ||
| (Vacuum Station) | ||
| Weight (kg) | 78 (Single Unit including Sampler) | 3.8 (Instrument) |