(245 days)
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.
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.
Here's an analysis of the provided text regarding the GloCyte® Automated Cell Counter System, focusing on acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in a dedicated table. However, it implicitly defines successful performance by stating that "Results were shown to meet acceptance criteria" for accuracy and "The results of the repeatability study met acceptance criteria." The reproducibility study also "met acceptance criteria." Based on the reported data, the implicit acceptance criteria would relate to achieving results within the stated ranges, slopes, intercepts, and CVs.
| Test Category | Acceptance Criteria (Implicit from "met acceptance criteria") | Reported Device Performance |
|---|---|---|
| Accuracy (Hemocytometer vs. GloCyte) | TNC: Slope ~1, Intercept ~0. Bias: none or within acceptable limits. | TNC Pediatric (N=129): Range 0-7,672; Slope 0.963 (0.909, 1.000); Intercept 0.037 (0.000, 0.182); Bias: none. |
| TNC Adult (N=223): Range 0-9,900; Slope 1.000 (1.000, 1.003); Intercept 0.000 (-0.003, 0.000); Bias: none. | ||
| RBC: Slope ~1, Intercept ~0. Bias: none or within acceptable limits. | RBC Pediatric (N=196): Range 0-817,500; Slope 0.910 (0.885, 0.935); Intercept 0.000 (-0.045, 0.058); Bias: -9% (proportional). | |
| RBC Adult (N=267): Range 0-901,250; Slope 1.000 (0.986, 1.007); Intercept 0.000 (0.000, 0.015); Bias: none. | ||
| Repeatability (%CV) | Within acceptable CV limits (not explicitly defined numerically, but met by observed values). | TNC (N=26): Range 4-10,313 cells/uL; %CV Results 2.5-18.0. |
| RBC (N=29): Range 5-727,800 cells/uL; %CV Results 2.7-16.3. | ||
| Precision/Reproducibility (%CV) | Within acceptable CV limits for Within-Run, Between-Run, Between-Day, Between-Site, Between-Operator, and Total. | TNC Low (N=480): Mean 10.6; 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 (N=480): Mean 122.9; 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 (N=480): Mean 11.3; 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 (N=480): Mean 130.0; Within-Run 5.3, Between-Run 0.0, Between-Day 0.7, Between-Site 1.7, Between-Operator 1.0, Total 5.7. | ||
| Linearity | A linear relationship between measured and expected values. | TNC: 0-7,438 cells/µL. |
| RBC: 0-615,644 cells/µL. | ||
| Reportable Range | LoQ combined with linear range. | TNC: 3-6,500 cells/µL. |
| RBC: 2-615,644 cells/µL. | ||
| Interfering Substances | No interference observed at specified concentrations. | Reported in Table 5-8, detailing highest concentrations with no observed interference for various substances (Bilirubin, Hemoglobin, Protein, Lactate, various bacteria, Candida albicans, Platelets, Monocytes). Note: Hemolytic Hemoglobin, RBC fragments, and Nucleated RBCs were noted as potential interferents for certain assays. |
| Quality Control Stability | Stability claim of 7 months for controls stored at 2-8°C. | Data supports a preliminary stability claim of 7 months based on testing at Month 7. |
2. Sample Size Used for the Test Set and Data Provenance
- Accuracy Study (Hemocytometer vs. GloCyte):
- TNC Pediatric: 129 samples
- TNC Adult: 223 samples
- RBC Pediatric: 196 samples
- RBC Adult: 267 samples
- Data Provenance: "clinical sites and in-house using clinical and contrived CSF specimens." This indicates a mix of prospective (clinical) and possibly retrospective (clinical) or laboratory-prepared (contrived) data. The country of origin is not specified but implicitly US, given the FDA submission.
- Repeatability Study:
- TNC: 26 samples
- RBC: 29 samples
- Data Provenance: "three clinical sites and in-house using clinical and manipulated CSF specimens as well as GloCyte® Low and High Level Controls." Similar to accuracy, a mix of data types and locations.
- Precision/Reproducibility Study:
- Each TNC and RBC level (Low/High) had 480 measurements (likely 2 operators * 2 measurements/day * 20 days * 3 sites).
- Data Provenance: "three clinical sites," using GloCyte® Low and High Level Controls.
- Linearity Study:
- Used "Contrived RBC and TNC CSF samples, created by dilution of human blood cells into blank CSF." Tested on three GloCyte® Automated Cell Counter Systems.
- Determination of LoB, LoD, LoQ:
- No specific sample size mentioned, but studies were conducted "according to CLSI EP17-A2."
- Interfering Substances:
- No specific sample size mentioned for each interferent, but "Interference testing was conducted."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number or qualifications of experts used to establish ground truth for the test sets. For the accuracy study comparing GloCyte to Hemocytometer, the Hemocytometer results would serve as the comparative method. However, who performed the hemocytometer counts and their qualifications are not detailed.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method (e.g., 2+1, 3+1) for establishing the ground truth or resolving discrepancies in the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done. The device is an automated cell counter, which aims to replace or assist manual counting, but the study described focuses on the device's analytical performance against established methods, not human reader performance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Yes, the studies described are standalone performance evaluations of the GloCyte® Automated Cell Counter System. The device is designed to be an automated system, and the reported accuracy, repeatability, precision, linearity, and reportable range studies all reflect the algorithm and instrument's performance without direct human intervention in the cell counting process for the test results.
7. The Type of Ground Truth Used
- For the accuracy study, the ground truth for TNC and RBC counts was established by comparison against Hemocytometer counts ("Hemocytometer vs. GloCyte TNC and RBC counts").
- For repeatability, precision/reproducibility, linearity, LoB, LoD, LoQ, and interfering substances, the ground truth was implicitly the expected value or reference method result derived from standard laboratory practices and controlled preparations, rather than expert consensus on individual cases or pathology reports. For example, linearity uses "true concentrations of the analyte" and "expected values."
8. The Sample Size for the Training Set
The document does not mention the sample size for a "training set." The GloCyte® Automated Cell Counter System uses digital image analysis principles to count cells. While such systems are often developed using training data, this submission focuses on the validation or performance testing datasets. It does not provide details about model development or the data used to "train" its algorithms.
9. How the Ground Truth for the Training Set Was Established
Since no training set is discussed or implied in the provided text, the method for establishing its ground truth is also not elaborated upon.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of three human profiles facing right, arranged in a way that they appear to be interconnected. The profiles are black against a white background. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the profile graphic.
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
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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-parameterautomated hematology analyzersintended for in vitro diagnostic use inscreening patient populations found inclinical laboratories. The XN-Seriesmodules classify and enumerate thefollowing 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 bodyfluids. The Body Fluid modeenumerates the WBC-BF, RBC-BF,MN%/#, PMN%/#, and TC-BFparameters in cerebrospinal fluid (CSF),serous fluids (peritoneal, pleural) andsynovial fluids. Whole blood should becollected in K2 or K3EDTAanticoagulant and, Serous and Synovialfluids in K2EDTA anticoagulant toprevent clotting of fluid. The use ofanticoagulants with CSF specimens isneither required nor recommended. | The GloCyte® Automated CellCounter System is intended for use bytrained healthcare professionals inclinical laboratories to providequantitative determination offluorescence labeled total nucleatedcells and erythrocytes in cerebrospinalfluid collected from adult andpediatric patients. |
| Test Principles | Performs hematology analysisaccording to the Hydro DynamicFocusing (DC Detection), flowcytometry method (using asemiconductor laser), and SLS-hemoglobin method. | Detection of fluorescence from stainedRBCs/TNCs using semiconductor laserand 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 glycophorinA/B antibody fluorescent stain). |
| Calibrators | XN-10 Calibrator (XN CAL) | No external calibrator |
| Sample/Fluidic Pathway | Single fluidic pathway | No fluidic pathway |
| Dimensions ofMain Unit | Width: 645mmHeight: 855mmDepth: 755mm(Single Unit including Sampler) | Width: 153mmHeight: 255mmDepth: 204mm(Instrument)Width: 121mmHeight: 108mmDepth: 108mm(Vacuum Station) |
| Weight (kg) | 78 (Single Unit including Sampler) | 3.8 (Instrument)<1.0 (Vacuum Station) |
| Throughput | 40 samples/hour maximum | 6-15 samples/hour. |
| Sample Volume | 88µL | 30µL for TNC test30µL for RBC test |
| Controls | XN Check BF – 2 Levels | GloCyte® Low and High LevelControls– 2 Levels |
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Table 5-2. Substantial Equivalence Table Comparing GloCyte® Automated Cell Counter System to Predicate Device: Differences
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5.7 Performance Data
Accuracy
Accuracy was established according to CLSI EP09 Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline-Third Edition (2013). Method comparison studies were performed at clinical sites and in-house using clinical and contrived CSF specimens. Results were shown to meet acceptance criteria.
| CellType | Population | N | Range | Slope(95% CI) | Intercept(95% CI) | ConstantBias | ProportionalBias |
|---|---|---|---|---|---|---|---|
| TNC | Pediatric | 129 | 0 – 7,672 | 0.963(0.909, 1.000) | 0.037(0.000, 0.182) | none | none |
| Adult | 223 | 0 – 9,900 | 1.000(1.000, 1.003) | 0.000(-0.003, 0.000) | none | none | |
| RBC | Pediatric | 196 | 0 – 817,500 | 0.910(0.885, 0.935) | 0.000(-0.045, 0.058) | none | -9% |
| Adult | 267 | 0 – 901,250 | 1.000(0.986, 1.007) | 0.000(0.000, 0.015) | none | none |
Table 5-3. Hemocytometer vs. GloCyte TNC and RBC counts
Repeatability
A repeatability study was conducted at three clinical sites and in-house using clinical and manipulated CSF specimens as well as GloCyte® Low and High Level Controls. The results of the repeatability study met acceptance criteria.
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| 1 400 V To 21 / 0 Milli 2020 / 200 / 000 / 000 / 000 / 000 / 000 / 000 / 000 / 000 / 000 / 000 / 000 / 000 / 000 / 000 / 000 / 000 / 000 / 000 / 000 / 000 / 000 / 000 / 000 / | |||||||
|---|---|---|---|---|---|---|---|
| Cell Tvpe | Number of Samples Range Tested [cells/uL] | %CV Results | |||||
| TNC | 26 | 4 - 10.313 | 2.5 - 18.0 | ||||
| RBC | 29 | 5 - 727,800 | 2.7 - 16.3 |
Table 5-4. TNC and RBC Repeatability
Precision/Reproducibility
A reproducibility study was conducted at three clinical sites. The study involved testing a set of GloCyte® Low and High Level Controls for both RBC and TNC parameters, performed by two operators. Testing was done twice daily using the same lot of controls, for twenty nonconsecutive days. The results of the precision study met acceptance criteria.
| CellType | Level | N | Mean[cells/µL] | %CV | |||||
|---|---|---|---|---|---|---|---|---|---|
| Within-Run | Between-Run | Between-Day | Between-Site | Between-Operator | Total | ||||
| TNC | Low | 480 | 10.6 | 10.1 | 0.0 | 1.6 | 3.9 | 2.4 | 11.2 |
| High | 480 | 122.9 | 5.9 | 0.0 | 0.0 | 3.1 | 1.5 | 6.9 | |
| RBC | Low | 480 | 11.3 | 9.2 | 0.0 | 1.9 | 3.8 | 2.7 | 10.5 |
| High | 480 | 130.0 | 5.3 | 0.0 | 0.7 | 1.7 | 1.0 | 5.7 |
Table 5-5. TNC and RBC Reproducibility
Linearitv
Linearity was established according to CLSI EP6-A Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline (2003). The analytical method is linear when the observed values have a mathematically verified straight-line relationship with true concentrations of the analyte, i.e. they are directly proportional to each other.
Contrived RBC and TNC CSF samples, created by dilution of human blood cells into blank CSF, were used for linearity studies on three GloCyte® Automated Cell Counter Systems. 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 below.
| CellType | Range [cells/µL] |
|---|---|
| TNC | 0 - 7,438 |
| RBC | 0 - 615,644 |
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510(k) Summary for
Glocyte® Automated Cell Counter System and Glocyte® Low and High Level Controls
Determination of limit of blank, limit of detection, limit of quantitation and reportable range
Limit of Blank (LoB),Limit of Detection (LoD) and Limit of Quantitation (LoQ) were performed according to CLSI EP17-A2 Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline-Second Edition (2012). The LoQ, combined with the linear range was used to determine the reportable range. See table 5-7 below:
Table 5-7 Reportable Range
| Cell Type | Reportable Range[cells/μL] |
|---|---|
| TNC | 3 – 6,500 |
| RBC | 2 – 615,644 |
Interfering Substances
Interference testing was conducted to determine if endogenous and external substances might interfere with results. Table 5-8 lists potential interferents tested and the test results.
| PotentialInterferent | GloCyteAssay | Highest Concentration at whichNo Interference was observed |
|---|---|---|
| ConjugatedBilirubin | TNC | 307.8 µmol/L (18.0 mg/dL) |
| RBC | 307.8 µmol/L (18.0 mg/dL) | |
| UnconjugatedBilirubin | TNC | 323.2 µmol/L (18.9 mg/dL) |
| RBC | 323.2 µmol/L (18.9 mg/dL) | |
| HemolyticHemoglobin | TNC | 1.1 g/dL1 |
| RBC | NONE2 | |
| Protein | TNC | 59.0 g/L |
| RBC | 59.0 g/L | |
| Lactate | TNC | 13.2 mmol/L |
| RBC | 13.2 mmol/L | |
| Haemophilusinfluenzae | TNC | 108 CFU/mL |
| RBC | 108 CFU/mL | |
| Streptococcuspneumoniae | TNC | 108 CFU/mL |
| RBC | 108 CFU/mL | |
| Neisserialactamica | TNC | 107 CFU/mL |
| RBC | 108 CFU/mL | |
| Escherichia coli | TNC | 108 CFU/mL |
| RBC | 108 CFU/mL |
Table 5-8. Interference Results Summary
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| Candida albicans | TNC | $10^8$ CFU/mL |
|---|---|---|
| RBC | $10^8$ CFU/mL | |
| Platelets | TNC | 14.7 x $10^3$ Platelets/µL |
| RBC | 14.7 x $10^3$ Platelets/µL | |
| Nonspecific FcRBinding(Monocytes) | RBC | 1.7 x $10^3$ Monocytes/µL |
| RBC Fragments | RBC | Could Not be Quantified $^3$ . |
| Nucleated RBCs | TNC | None $^4$ |
-
Cellular debris in the hemolytic hemoglobin may cause interference for the GloCyte TNC Assay.
-
RBC fragments and cellular debris in hemoglobin may cause interference for the GloCyte RBC Assay.
-
Quantitation of RBC fragment interference levels was not possible due to the enormous variety of RBC fragment sizes and RBC ghost cells present. RBC fragments, tested as part of the hemolytic hemoglobin, may cause interference for the RBC Assay.
-
Nucleated RBCs are counted by the GloCyte TNC Assay and are considered an interferent. Note nucleated RBCs are also counted by the GloCyte RBC Assay.
Quality Control Stability
GloCyte® Low and High Level Controls closed vial (shelf life) stability study data support a preliminary stability claim of 7 months when stored at 2-8°C. This stability claim is based on the time point (Month 7) tested prior to the last time point that yielded test results within the acceptance criteria for all three (3) GloCyte® Low and High Level Control lots.
5.8 Conclusions
Data in this Premarket Notification for the GloCyte® Automated Cell Counter System meet the manufacturer's specifications and support a finding of substantial equivalence to the predicate device.
§ 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).