POINTCARE NOW SYSTEM

K072869 · Pointcare Technologies, Inc. · GKZ · Jan 14, 2008 · Hematology

Device Facts

• Record ID: K072869
• Device Name: POINTCARE NOW SYSTEM
• Applicant: Pointcare Technologies, Inc.
• Product Code: GKZ · Hematology
• Decision Date: Jan 14, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5220
• Device Class: Class 2

Indications for Use

The PointCare NOW System is an automated hematology system intended for in vitro diagnostic use in performing the direct enumeration of major white blood cell populations, certain t-lymphocyte subset, and hemoglobin concentration from human whole blood.

Device Story

PointCare NOW System is a compact, automated flow-based immune hematology analyzer; utilizes touch screen interface and processor for system operation/data analysis. Input: anticoagulated whole blood samples. Principle: photometer for hemoglobin; impedance orifice for WBC; multi-angle light scatter cytometer for other parameters. Gold particle-conjugated anti-CD4 monoclonal antibody binds cell surface to impart granularity; wide-angle scatter measures granularity; forward-angle scatter measures cell size. System distinguishes/enumerates CD4+ T-Helper lymphocytes, WBC populations, and hemoglobin. Output: quantitative hematology results displayed on screen; data stored in internal memory (8,000 analyses) or external travel drive (50,000 analyses). Used in clinical settings for immune hematology monitoring; operated by trained personnel. Automated features include cap piercing, closed tube sampling, mixing, and temperature control. Results assist clinicians in hematologic assessment and immune status monitoring.

Clinical Evidence

Prospective multi-site study (n=249) compared PointCare NOW results against cleared predicate devices. Pearson correlation coefficients (r) for key parameters: WBC (0.991), Lymphocyte count (0.994), Neutrophil count (0.985), and Hemoglobin (0.956). Precision studies (within-run and total) showed acceptable CVs across low and normal control levels. Linearity studies confirmed performance across reportable ranges (r > 0.99). Carryover studies demonstrated minimal impact (WBC 0.51%, Hgb 0.00%). Antigen specificity of the CD4 antibody was established via international workshops.

Technological Characteristics

Compact flow-based immune hematology analyzer. Sensing: photometer (Hgb), impedance orifice (WBC), multi-angle light scatter (cytometry). Reagent: Anti-CD4 monoclonal antibody conjugated to colloidal gold. Connectivity: integrated touch screen, USB memory stick/travel drive for data transfer. Software: Epsilon OSE-based, automated cluster finding algorithms. Factory calibrated. Closed-tube, automated cap-piercing system.

Indications for Use

Indicated for the analysis of human whole blood samples to determine White Blood Cell count, Lymphocyte Count, Lymphocyte %, CD-4 Lymphocyte Count, CD-4 Lymphocyte %, Monocyte Count, Monocyte %, Neutrophil Count, Neutrophil %, Eosinophil Count, Eosinophil %, and Hemoglobin Concentration.

Regulatory Classification

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.

Special Controls

*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.”

Predicate Devices

• FlowCare/AuRICA Flow Cytometer (K041882)
• Excell 22 Hematology Analyzer (K991539)
• Sysmex XE-2100 Hematology Analyzer (K992875)
• FlowCare PLG™ System for EPICS XL Flow Cytometry Systems (K043215)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE

A. 510(k) Number:
K072869

B. Purpose for Submission:
Traditional 510(k) with modifications of a previously cleared device.

C. Measurand:
The device enumerates white blood cell populations, certain T-lymphocyte subsets, and hemoglobin concentration from human whole blood.

D. Type of Test:
Quantitative, automated flow cytometry.

E. Applicant:
PointCare Technologies, Inc.

F. Proprietary and Established Names:
PointCare NOW System

G. Regulatory Information:
1. Regulation section:
21 CFR 864.5220
2. Classification:
Class II
3. Product code:
GKZ

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4. Panel:

Hematology (81)

H. Intended Use:

1. Intended use(s):

The PointCare NOW System is an automated hematology system intended for in vitro diagnostic use in performing the direct enumeration of major white blood cell populations, certain t-lymphocyte subset, and hemoglobin concentration from human whole blood.

2. Indication(s) for use:

Whole blood samples can be analyzed with the PointCare NOW System for the following parameters: White Blood Cell count, Lymphocyte Count, Lymphocyte %, CD-4 Lymphocyte Count, CD-4 Lymphocyte %, Monocyte Count, Monocyte %, Neutrophil Count, Neutrophil %, Eosinophil Count, Eosinophil %, Hemoglobin Concentration.

3. Special conditions for use statement(s):

N/A

4. Special instrument requirements:

N/A

I. Device Description:

The PointCare Now System uses an integrated touch screen interface and a processor as its central processing unit for system operation and data analysis. The epsilon OSE-based software analyses the patient sample for immune hematology parameters, with automated cluster finding algorithms. The Internal Storage Memory allows for the storage of up to 8,000 analyses. The included memory stick/travel drive facilitates the easy transfer of patient results from the system computer to another, and additionally expands the system to store up to 50,000 analyses.

J. Substantial Equivalence Information:

1. Predicate device name(s):

a. FlowCare/AuRICA Flow Cytometer
b. Sysmex XE-2100 Hematology Analyzer

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c. FlowCare PLG System for EPICS XL Flow Cytometry Systems

2. Predicate 510(k) number(s):

a. K041882
b. K992875
c. K043215

3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Specimen Sample | Anticoagulated whole blood | FlowCare/AURICA: Same Sysmex XE-2100: Same |
| CD4 Reagent | Anti-CD4 monoclonal antibody conjugated to colloidal gold substrate | FlowCare/AURICA: Same |
| Principle of Operation | Light Scatter and Impedance | Sysmex XE-2100: Same |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | Determination of WBC count, 4-part differential, CD4 T-Lymphocyte count, CD4 %, and hemoglobin. | FlowCare AuRICA: WBC count, Lymphocyte count, Lymphocyte %, CD4 T-Lymphocyte count, and CD4 %. Sysmex XE-2100: 5-part differential, hemoglobin, plus other hematologic parameters including RBCs and platelets. FlowCare PLG: CD4 % (CD4 T-Lymphocyte count=CD4% x Lymphocyte count from hematology analyzer. |

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| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Specimen Sample | Anticoagulated whole blood | FlowCare PLG: Lysed anticoagulated whole blood. |
| CD4 Reagent | Anti-CD4 monoclonal antibody conjugated to colloidal gold substrate. | FlowCare PLG: Anti-CD4 monoclonal antibody labeled with fluorochrome. |
| Instrumentation: | Compact flow-based immune hematology analyzer with integrated touch screen and software. | FlowCare AuRICA: Compact flow-based immune hematology analyzer with computer and software.
Sysmex XE-2100: Standard hematology analyzer with computer and software.
FlowCare PLG: Standard flow cytometer with computer and software. |
| Principle of Operation | Light scatter and impedance | FlowCare AuRICA: Light scatter
FlowCare PLG: Light scatter and fluorescence |

K. Standard/Guidance Document Referenced (if applicable):

a. 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 Staff, January 11, 2002.

b. Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 29, 1998.

L. Test Principle:

The system uses a photometer for Hgb, and impedance orifice for WBC, and a multi-angle light scatter cytometer for all other parameters. The multi-angle light scatter cytometer measures wide angle light scatter as a cell granularity index and low angle scatter as a cell size index. The gold particle anti-CD4 monoclonal antibody conjugate binds to the cell

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surface and imparts granularity to the cell. Wide angle light scatter is used to detect granular cells and forward angle scatter is used to size cells making it possible to distinguish and enumerate CD4 positive T-Helper lymphocytes from other lymphocytes and other white blood cell types.

## M. Performance Characteristics (if/when applicable):

### 1. Analytical performance:

#### a. Precision/Reproducibility:

The precision study was performed to assess the within-run precision and total precision of the PointCare NOW system by replicate measurements of control materials. Control materials were analyzed on two PointCare Now instruments in accordance with the instructions for use. For each instrument, the precision study was performed on three days. On each day, testing consisted of three separate runs. In each run, three replicate measurements were performed for each level of control material. The control materials used were Bi-level Hematology Controls (Streck STak-CHEX Low and Normal.

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Table 1: Summary of Within-Run Precision and Total Precision

| | | PointCare NOW S/N 0015 | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Level | | WBC# | NEUT# | NEUT% | MONO# | MONO% | EOS# | EOS% | HGB |
| Low N = 27 | Grand Mean | 2.7 | 1.1 | 41.9 | 0.3 | 10.1 | 0.1 | 2.9 | 6.2 |
| | Within-Run Precision: | | | | | | | | |
| | Std. Dev. | 0.1 | 0.1 | 1.6 | 0.0 | 1.5 | 0.0 | 0.7 | 0.1 |
| | CV(%) | 2.5 | 4.8 | 3.9 | 14.9 | 14.9 | 21.2 | 22.7 | 0.8 |
| | Total Precision: | | | | | | | | |
| | Std. Dev. | 0.1 | 0.1 | 2.4 | 0.0 | 1.5 | 0.0 | 0.7 | 0.1 |
| | CV(%) | 2.7 | 5.5 | 5.8 | 15.3 | 14.9 | 21.2 | 22.7 | 1.2 |
| | | | | | | | | | |
| Normal N = 27 | Grand Mean | 7.6 | 3.9 | 50.9 | 0.7 | 9.4 | 0.7 | 5.7 | 9.8 |
| | Within-Run Precision: | | | | | | | | |
| | Std. Dev. | 0.1 | 0.1 | 1.6 | 0.1 | 1.3 | 0.1 | 0.7 | 0.0 |
| | CV(%) | 1.2 | 3.7 | 3.1 | 14.0 | 13.9 | 14.0 | 11.9 | 0.4 |
| | Total Precision: | | | | | | | | |
| | Std. Dev. | 0.1 | 0.1 | 1.7 | 0.1 | 1.3 | 0.1 | 0.8 | 0.0 |
| | CV(%) | 1.3 | 3.7 | 3.4 | 14.0 | 13.9 | 14.0 | 14.6 | 1.2 |
| | | PointCare NOW S/N 0019 | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Level | | WBC# | NEUT# | NEUT% | MONO# | MONO% | EOS# | EOS% | HGB |
| Low N = 27 | Grand Mean | 2.6 | 1.2 | 44.5 | 0.2 | 9.4 | 0.1 | 2.8 | 6.1 |
| | Within-Run Precision: | | | | | | | | |
| | Std. Dev. | 0.1 | 0.1 | 1.6 | 0.1 | 2.5 | 0.0 | 0.5 | 0.1 |
| | CV(%) | 3.8 | 6.0 | 3.6 | 30.5 | 26.5 | 4.8 | 18.5 | 1.1 |
| | Total Precision: | | | | | | | | |
| | Std. Dev. | 0.1 | 0.1 | 2.1 | 0.1 | 2.5 | 0.0 | 0.5 | 0.1 |
| | CV(%) | 3.8 | 7.4 | 4.7 | 30.5 | 26.5 | 4.8 | 19.0 | 1.5 |
| | | | | | | | | | |
| Normal N = 27 | Grand Mean | 7.4 | 3.9 | 53.2 | 0.7 | 9.2 | 0.4 | 5.8 | 9.6 |
| | Within-Run Precision: | | | | | | | | |
| | Std. Dev. | 0.1 | 0.1 | 1.4 | 0.1 | 1.5 | 0.0 | 0.3 | 0.1 |
| | CV(%) | 1.0 | 2.7 | 2.5 | 15.2 | 16.2 | 9.3 | 4.7 | 0.6 |
| | Total Precision: | | | | | | | | |
| | Std. Dev. | 0.1 | 0.1 | 1.4 | 0.1 | 1.5 | 0.0 | 0.3 | 0.1 |
| | CV(%) | 1.3 | 3.0 | 2.6 | 15.8 | 16.3 | 9.3 | 4.7 | 1.1 |

A precision study was performed to assess the within-day precision of the PointCare NOW System by replicate measurements of whole blood samples. Whole blood samples were analyzed on two PointCare NOW instruments in accordance with the instructions for use. For each instrument, the precision study was performed on one day and testing consisted of ten separate runs. Four whole blood samples were used and selected to fall within three ranges (3,000-6,000 cells/μL; 6,000-8,000 cells/μL; and 8,000-10,000 cells/μL). The results demonstrated acceptable performance for the PointCare NOW System.

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b. Linearity/assay reportable range:

A linearity study was performed to assess the performance of the PointCare NOW System over a wide range of cell concentrations. For each parameter, measurements were made for cell concentration levels spanning the respective method ranges (full range). Also, WBC count and hemoglobin were also evaluated in the low range. For both the full range and low range studies, six concentration levels were analyzed. Samples for the full range study were prepared using a concentrated whole blood sample diluted with autologous platelet poor plasma to achieve the desired concentration levels. The sample for each concentration level was analyzed four times in random sequence on each of the two PointCare NOW instruments.

Table 2: Summary of Linearity Study

| Analysis of Results | WBC Count | Mono Count | Neut Count | Eos Count | HGB |
| --- | --- | --- | --- | --- | --- |
| Test for Linearity: | | | | | |
| N | 24 | 24 | 24 | 24 | 24 |
| Linear Fit: | | | | | |
| Correlation (r) | 0.999 | 0.996 | 0.999 | 0.996 | 0.999 |
| linear slope | 0.995 | 0.992 | 0.997 | 0.946 | 1.000 |
| linear intercept | 0.307 | -0.014 | 0.067 | 0.079 | 0.134 |
| Quadratic Fit: ax^2+bx=c | | | | | |
| quad fit a | -0.0010 | 0.1066 | 0.0079 | 0.0916 | -0.0066 |
| quad fit b | 1.0363 | 0.7560 | 0.8261 | 0.8224 | 1.1218 |
| quad fit c | 0.1976 | 0.0183 | 0.0742 | 0.0864 | -0.0183 |
| Standard Error | 1.7668 | 0.1298 | 1.2104 | 0.1250 | 0.3800 |
| t value | 0.0005 | 0.8211 | 0.0066 | 0.7326 | 0.0173 |
| critical t value | 2.0796 | 2.0796 | 2.0796 | 2.0796 | 2.0796 |
| Inference | linear | linear | linear | linear | linear |

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

N/A

d. Detection limit:

N/A

e. Analytical specificity:

N/A

f. Assay cut-off:

N/A

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# 2. Comparison studies:

# a. Method comparison with predicate device:

A multi-site (in-house and two outside sites) prospective study was conducted to evaluate the performance of the PointCare NOW System and reagents. A total of 249 whole blood samples met the study criteria and were analyzed by both the PointCare NOW method and two outside sites with cleared predicate devices.

Table 3: Method Comparison with Predicate Devices

| | | WBC | LYM | LYM% | NEU | NEU% | MON | MON% | EOS | EOS% | CD4DP | CD4SP | CD4% | HGB |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | Ladymeade Barbados | | | | | | | | | | | | |
| Comparison | Pearson (r) | 0.986 | 0.967 | 0.983 | 0.991 | 0.982 | 0.834 | 0.711 | 0.990 | 0.965 | 0.876 | 0.869 | 0.824 | 0.965 |
| | slope | 0.933 | 1.011 | 0.909 | 0.864 | 0.925 | 0.783 | 0.684 | 0.961 | 0.907 | 0.793 | 0.752 | 0.798 | 0.783 |
| | intercept | 0.293 | -0.056 | 2.943 | 0.280 | 2.925 | 0.093 | 2.441 | 0.100 | 2.246 | 40 | 48 | 2.453 | 2.571 |
| | n | 98 | 98 | 100 | 98 | 100 | 98 | 100 | 98 | 100 | 94 | 94 | 96 | 100 |
| PointCare NOW | mean value | 5.9 | 2.2 | 39.1 | 2.9 | 47.3 | 0.5 | 8.0 | 0.3 | 5.7 | | 414 | 19.5 | 12.5 |
| | min value | 1.1 | 0.4 | 12.0 | 0.2 | 10.9 | 0.1 | 1.5 | 0.1 | 1.4 | | 40 | 2.9 | 4.1 |
| | max value | 24.3 | 7.1 | 81.7 | 17.4 | 81.0 | 1.6 | 16.3 | 5.8 | 64.8 | | 1265 | 50.9 | 18.0 |
| Reference Method | mean value | 6.1 | 2.3 | 39.9 | 3.1 | 47.6 | 0.5 | 8.1 | 0.2 | 4.0 | 540 | 537 | 22.7 | 12.6 |
| | min value | 1.1 | 0.5 | 11.2 | 0.2 | 11.2 | 0.1 | 3.1 | 0.0 | 0.0 | 2 | 3 | 0.3 | 3.0 |
| | max value | 26.7 | 5.0 | 69.3 | 20.4 | 79.6 | 2.1 | 16.2 | 5.8 | 66.4 | 1934 | 1740 | 69.5 | 16.8 |
| | | PointCare Technologies | | | | | | | | | | | | |
| Comparison | Pearson (r) | 0.996 | 0.997 | 0.991 | 0.993 | 0.982 | 0.980 | 0.836 | 0.875 | 0.834 | 0.992 | 0.989 | 0.556 | 0.976 |
| | slope | 1.095 | 1.055 | 1.003 | 1.093 | 0.969 | 1.139 | 0.890 | 1.020 | 1.165 | 0.903 | 0.934 | 0.903 | 0.917 |
| | intercept | -0.403 | -0.052 | -0.352 | -0.325 | 0.134 | 0.007 | 1.706 | 0.112 | 1.281 | 111 | 123 | 3.725 | 1.222 |
| | n | 88 | 88 | 88 | 88 | 88 | 88 | 88 | 88 | 88 | 67 | 67 | 67 | 88 |
| PointCare NOW | mean value | 9.0 | 3.1 | 32.5 | 4.6 | 54.4 | 0.9 | 9.1 | 0.3 | 4.1 | | 1488 | 47.6 | 13.6 |
| | min value | 2.9 | 0.7 | 14.7 | 1.1 | 15.6 | 0.2 | 4.7 | 0.1 | 0.6 | | 139 | 8.8 | 7.0 |
| | max value | 37.2 | 22.2 | 68.2 | 16.1 | 74.1 | 5.9 | 20.3 | 1.0 | 8.7 | | 11699 | 77.2 | 17.6 |
| Reference Method | mean value | 8.6 | 3.0 | 32.8 | 4.5 | 56.0 | 0.8 | 8.3 | 0.2 | 2.4 | 1493 | 1427 | 48.9 | 13.4 |
| | min value | 3.0 | 0.7 | 15.0 | 1.2 | 15.7 | 0.2 | 4.5 | 0.0 | 0.4 | 58 | 50 | 7.5 | 6.9 |
| | max value | 35.0 | 21.5 | 68.0 | 15.0 | 74.4 | 5.1 | 20.0 | 0.9 | 5.8 | 12943 | 12023 | 70.7 | 22.0 |
| | | Belmont Medical | | | | | | | | | | | | |
| Comparison | Pearson (r) | 0.985 | 0.969 | 0.991 | 0.990 | 0.983 | 0.773 | 0.761 | 0.927 | 0.955 | | | | 0.994 |
| | slope | 0.953 | 1.008 | 1.008 | 0.896 | 0.932 | 0.977 | 0.778 | 0.609 | 0.700 | | | | 1.002 |
| | intercept | 0.157 | 0.146 | 2.595 | 0.186 | 1.532 | 0.039 | 2.164 | 0.079 | 0.923 | | | | 0.699 |
| | n | 61 | 61 | 61 | 61 | 61 | 61 | 61 | 61 | 61 | | | | 61 |
| PointCare NOW | min value | 3.7 | 1.0 | 11.7 | 1.1 | 30.0 | 0.3 | 6.1 | 0.1 | 0.6 | | | | 9.6 |
| | max value | 18.4 | 4.0 | 55.5 | 14.4 | 79.8 | 1.2 | 16.1 | 0.8 | 11.8 | | | | 18.5 |
| | mean value | 7.2 | 2.0 | 28.8 | 4.4 | 59.8 | 0.6 | 8.3 | 0.2 | 3.1 | | | | 14.7 |
| Reference Method | min value | 3.8 | 0.8 | 8.8 | 1.2 | 32.2 | 0.3 | 3.7 | 0.0 | 0.1 | | | | 8.9 |
| | max value | 18.7 | 3.6 | 52.5 | 16.0 | 85.5 | 1.0 | 13.0 | 1.1 | 15.9 | | | | 17.5 |
| | mean value | 7.4 | 1.8 | 26.0 | 4.7 | 62.5 | 0.6 | 7.9 | 0.2 | 3.1 | | | | 14.0 |
| | | Pooled - All Sites | | | | | | | | | | | | |
| Comparison | Pearson (r) | 0.991 | 0.994 | 0.983 | 0.985 | 0.984 | 0.966 | 0.770 | 0.969 | 0.940 | 0.989 | 0.986 | 0.883 | 0.956 |
| | slope | 1.059 | 1.049 | 0.913 | 0.966 | 0.924 | 1.124 | 0.801 | 0.939 | 0.904 | 0.916 | 0.950 | 0.952 | 0.908 |
| | intercept | -0.374 | -0.051 | 3.285 | 0.041 | 2.638 | -0.031 | 1.955 | 0.088 | 1.648 | 28 | 13 | 0.057 | 1.365 |
| | n | 247 | 247 | 249 | 247 | 249 | 247 | 249 | 247 | 249 | 161 | 161 | 163 | 249 |
| PointCare NOW | min value | 1.1 | 0.4 | 12.0 | 0.2 | 10.9 | 0.1 | 1.5 | 0.1 | 0.6 | | 40 | 2.9 | 4.1 |
| | max value | 37.2 | 22.2 | 81.7 | 17.4 | 81.0 | 5.9 | 20.3 | 5.8 | 64.8 | | 11699 | 77.2 | 20.1 |
| | mean value | 7.2 | 2.6 | 36.2 | 3.7 | 50.4 | 0.6 | 8.5 | 0.3 | 5.0 | | 873 | 31.1 | 12.9 |
| Reference Method | min value | 1.1 | 0.5 | 8.8 | 0.2 | 11.2 | 0.1 | 3.1 | 0.0 | 0.0 | 2 | 3 | 0.3 | 3.0 |
| | max value | 35.0 | 21.5 | 69.3 | 20.4 | 85.5 | 5.1 | 20.0 | 5.8 | 66.4 | 12943 | 12023 | 70.7 | 22.0 |
| | mean value | 7.3 | 2.4 | 34.0 | 4.0 | 54.2 | 0.6 | 8.1 | 0.2 | 3.2 | 967 | 911 | 33.8 | 13.2 |

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b. Matrix comparison:

N/A

# 3. Clinical studies:

a. Clinical Sensitivity:

N/A

b. Clinical specificity:

The antigen specificity of the CD4 monoclonal antibody has been previously established by the Fourth and Fifth International Workshops for Leukocyte Typing.

c. Other clinical supportive data (when a. and b. are not applicable):

A carryover study was performed to assess the effect of a whole blood sample on the background counts in subsequent analyses. The study was performed on two PointCare NOW instruments for the three different detection methods (WBC #, Hgb and Cytometer).

Table 4: Carryover

| Level | Replicate | PointCare NOW S/N 0019 | | |
| --- | --- | --- | --- | --- |
| | | WBC# | HGB | CYT |
| High | 1 | 19.5 | 16.5 | 26532 |
| | 2 | 19.9 | 16.5 | 31237 |
| | 3 | 19.6 | 16.3 | 29228 |
| Low | 1 | 0.1 | 0.0 | 148 |
| | 2 | 0.1 | 0.0 | 88 |
| | 3 | 0.0 | 0.0 | 48 |
| | Percent Carryover | 0.51% | 0.00% | 0.34% |
| | | | | |
| Level | Replicate | PointCare NOW S/N 0015 | | |
| | | WBC# | HGB | CYT |
| High | 1 | 20.8 | 17.4 | 32248 |
| | 2 | 20.7 | 17.4 | 33279 |
| | 3 | 20.1 | 17.4 | 34223 |
| Low | 1 | 0.1 | 0.0 | 169 |
| | 2 | 0.0 | 0.0 | 34 |
| | 3 | 0.0 | 0.0 | 20 |
| | Percent Carryover | 0.50% | 0.00% | 0.44% |

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4. Clinical cut-off:
N/A

5. Expected values/Reference range:

Expected values for each parameter for the PointCare NOW were calculated using an assumed health Northeaster United States population.

Table 5: Expected Values/Reference Range

| PointCare NOW Parameter | Males | | | | Females | | | | Combined (Males + Females + Unknowns) | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | N | Range | | Mean ± SD | N | Range | | Mean ± SD | N | Range | | Mean ± SD |
| | | Min | Max | | | Min | Max | | | Min | Max | |
| WBC | 39 | 4.7 | 9.8 | 6.7 ± 1.4 | 45 | 3.7 | 11.4 | 7.2 ± 1.9 | 134 | 3.7 | 13.3 | 7.0 ± 2.0 |
| HGB | 39 | 11.9 | 17.3 | 15.2 ± 1.2 | 45 | 11.7 | 15.6 | 13.9 ± 0.9 | 134 | 11.2 | 17.1 | 14.2 ± 1.3 |
| LYM | 39 | 1.1 | 3.0 | 1.9 ± 0.5 | 45 | 1.1 | 3.4 | 2.1 ± 0.6 | 134 | 1.1 | 4.0 | 2.0 ± 0.6 |
| LYM% | 39 | 14.3 | 41.2 | 28.3 ± 6.5 | 45 | 13.2 | 44.4 | 30.6 ± 6.9 | 134 | 14.3 | 45.8 | 29.9 ± 7.2 |
| NEU | 39 | 2.5 | 6.7 | 4.0 ± 1.1 | 45 | 1.5 | 7.1 | 4.2 ± 1.4 | 134 | 1.9 | 8.0 | 4.1 ± 1.3 |
| NEU% | 39 | 45.9 | 68.5 | 59.4 ± 6.4 | 45 | 44.4 | 78.0 | 58.2 ± 7.0 | 134 | 41.5 | 74.1 | 57.9 ± 7.2 |
| MON | 39 | 0.4 | 0.9 | 0.6 ± 0.2 | 45 | 0.3 | 0.9 | 0.6 ± 0.2 | 134 | 0.3 | 1.3 | 0.6 ± 0.2 |
| MON% | 39 | 6.1 | 12.9 | 8.7 ± 1.6 | 45 | 6.1 | 11.3 | 7.9 ± 1.4 | 134 | 5.6 | 12.9 | 8.3 ± 1.6 |
| EOS | 39 | 0.1 | 0.4 | 0.2 ± 0.1 | 45 | 0.1 | 0.7 | 0.2 ± 0.1 | 134 | 0.1 | 0.7 | 0.3 ± 0.1 |
| EOS% | 39 | 1.0 | 7.1 | 3.2 ± 1.4 | 45 | 0.9 | 7.0 | 3.4 ± 1.5 | 134 | 1.0 | 7.8 | 3.7 ± 1.6 |
| CD4 | 9 | 443 | 1029 | 739 ± 230 | 10 | 725 | 1686 | 1070 ± 291 | 56 | 369 | 1718 | 941 ± 330 |
| CD4% | 9 | 25.3 | 46 | 37.8 ± 6.6 | 10 | 40.7 | 58.5 | 51.8 ± 6.7 | 56 | 21.1 | 74.0 | 48.7 ± 12.4 |

N. Instrument Name:
PointCare NOW System

O. System Descriptions:

1. Modes of Operation:
Fully-automated cap piercing, closed tube system with position recognition.

2. Software:
FDA has reviewed applicant's Hazard Analysis and software development processes for this line of product types:
Yes ☐ X ☑ or No ☐ Software was reviewed at a Moderate Level of Concern.

{10}

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3. Specimen Identification:

Barcode reader with tube position verification.

4. Specimen Sampling and Handling:

Fully-automated closed tube piercing, automated mixing, and control reaction temperature.

5. Calibration:

The PointCare NOW System is factory calibrated.

6. Quality Control:

PointCare recommends running fixed whole blood hematology controls, CBCNOW Control Normal and CBCNOW Control Low, and fixed whole blood CD4 controls, CD4NOW Control Normal and CD4NOW Control Low, at the beginning of each work day before performing sample analysis.

P. Other Supportive Instrument Performance Characteristics Data Not Covered In The "Performance Characteristics" Section above:

N/A

Q. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

R. Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

S. Other Supportive Device and Instrument Information:

N/A