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 subsets, and hemoglobin concentration from human whole blood.

Whole blood samples can be analyzed with the PointCare NOW System for the following parameters:

White Blood Cell Count
Lymphocyte Count
Lymphocyte Percentage (of White Blood Cells)
CD4 T-Lymphocyte Count
CD4 Percentage (of total Lymphocytes)
Monocyte Count
Monocyte Percentage (of White Blood Cells)
Neutrophil Count
Neutrophil Percentage (of White Blood Cells)
Eosinophil Count
Eosinophil Percentage (of White Blood Cells)
Hemoglobin Concentration

The PointCare NOW System and its methods for immune hematology analysis are intended for in vitro diagnostic use in clinical laboratory settings.

Device Description

The PointCare NOW System is a compact bench top immune hematology system that from analysis of a whole blood sample reports the hematology parameters identified within the Intended Use section below. The PointCare NOW System consists of an analysis instrument with an integrated touch screen interface and a commercially available tape roll printer.

The CD4NOW Gold Pack is used within the PointCare NOW System and all assay steps are performed on whole blood with capped bar-coded reagents designed for use on the PointCare NOW System. All assay aspiration, dispensing and mixing steps are automated. The PointCare NOW System reports parameter results on the basis of software analysis of light scatter measurements with the use of non-fluorescent reagents. Automated cell population cluster analysis is performed by the software and results provided with no operator interpretation.

AI/ML Overview

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

Here's an analysis of its acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific, quantifiable acceptance criteria for each parameter (e.g., specific ranges for precision, linearity, or acceptable bias compared to reference methods). Instead, it describes general positive outcomes of the testing.

Test Type	Acceptance Criteria (Explicitly Stated in Document)	Reported Device Performance
Electrical Testing	Compliance with applicable requirements of CFR 47 Part 15 Class A, IEC 61000, UL 61010, and EN 61326.	The instrument was found to be in compliance with applicable requirements of CFR 47 Part 15 Class A, IEC 61000, UL 61010, and EN 61326.
Precision Study	Acceptable within-run and total precision.	"Results of these studies demonstrated acceptable precision of the PointCare NOW System." (Includes within-run, total precision with control materials over three days, and within-day precision using whole blood samples in ten replicates.)
Linearity Study	Linearity demonstrated over a wide range of cell concentrations for measured parameters, with specific evaluation for WBC count and Hemoglobin in the low range.	"Linearity was demonstrated in all cases." (Evaluated for WBC count and Hemoglobin in the low range, and across a wide range of cell concentrations for other measured parameters; least squares regression analysis was performed.)
Carryover Study	Negligible carryover effect.	"Negligible carryover was observed."
Clinical Testing	Comparable means and ranges to commercially available reference methods for various parameters.	"The analyses of the pooled data showed comparable means and ranges for the PointCare NOW and reference method parameters." (For White Blood Cell Count, Lymphocyte Count, Lymphocyte Percentage, CD4 T-Lymphocyte Count, CD4 Percentage, Monocyte Count, Monocyte Percentage, Neutrophil Count, Neutrophil Percentage, Eosinophil Count, Eosinophil Percentage, Hemoglobin Concentration).

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size: "A multi-site prospective study was conducted at four investigational sites to evaluate the performance of the PointCare NOW System with other commercially available methods. A total of evaluable samples were analyzed across all participating sites." The specific numerical total of evaluable samples is not provided in the summary.
Data Provenance: The study was a "multi-site prospective study," indicating the data was collected specifically for this evaluation. The country of origin is not explicitly stated, but the sponsor is a US company (Marlborough, MA), and the FDA 510(k) process is for devices marketed in the United States, suggesting the study likely took place in the US or in a region using similar clinical standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not provided in the summary. The clinical testing describes a comparison to "other commercially available methods" (reference methods), but it does not specify direct expert interpretation or a panel of experts to establish a "ground truth" that would be distinct from the output of the reference methods themselves.

4. Adjudication Method for the Test Set

This information is not provided in the summary. Since the comparison is against "commercially available methods" (likely established laboratory analyzers), it's improbable that a separate adjudication process involving human experts to resolve discrepancies was conducted in the typical sense for image interpretation or diagnosis. Instead, the reference methods are likely considered the "ground truth" or standard for comparison.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described for this device. The PointCare NOW System is an automated analyzer, meaning it generates results without direct human interpretation in the workflow. The summary explicitly states: "Automated cell population cluster analysis is performed by the software and results provided with no operator interpretation." Therefore, the concept of "human readers improving with AI assistance" does not apply to this device's intended use according to the provided information.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, a standalone performance evaluation was done. The entire premise of the PointCare NOW System, as described, is its automated nature. The summary states: "Automated cell population cluster analysis is performed by the software and results provided with no operator interpretation." The clinical testing directly evaluates the performance of the PointCare NOW System (the algorithm/device as a whole) against reference methods.

7. The Type of Ground Truth Used

The ground truth for the clinical study was established by "other commercially available methods" which served as "reference methods." These would typically be established, FDA-cleared or CE-marked hematology analyzers or flow cytometers that are widely accepted in clinical laboratory settings. This implicitly means the ground truth is derived from established laboratory analysis/measurement, not pathology review, expert consensus on images, or long-term outcomes data.

8. The Sample Size for the Training Set

This information is not provided in the summary. The document describes performance testing for regulatory submission but does not delve into the development or training of the internal software/algorithms.

9. How the Ground Truth for the Training Set was Established

This information is not provided in the summary. As the document focuses on regulatory performance testing, details about the internal development and training of the device's algorithms or the ground truth used during that stage are not included.

Summary

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510(k) Summary for PointCare NOW System

1. SPONSOR

PointCare Technologies, Inc. 181 Cedar Hill Street Marlborough, MA 01752

|JAN 1 4 2008

K072869

Contact Person: Maurice N. Doire, Dir. of Quality Assurance and Regulatory Affairs

Telephone: 508-281-6925 ext. 22

Date Prepared: October 3, 2007

2. DEVICE NAME

Proprietary Name:	PointCare NOW System
Common/Usual Name:	Automated Immune Hematology System
Classification Name:	Automated Differential Cell Counter

3. PREDICATE DEVICES

. FlowCare/AuRICA Flow Cytometer PointCare Technologies, Inc. K041882
Excell 22 Hematology Analyzer . MWI, Inc. K991539
. Sysmex XE-2100 Hematology Analyzer Sysmex Corp. K992875
FlowCare PLG™ System for EPICS XL Flow Cytometry Systems . Beckman Coulter, Inc. K043215

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4. DEVICE DESCRIPTION

5. INTENDED USE

Whole blood samples can be analyzed with the PointCare NOW System for the following parameters:

White Blood Cell Count (Changed principle from FlowCare) .
Lymphocyte Count (Unchanged from FlowCare) .
Lymphocyte Percentage (of White Blood Cells) (Unchanged from FlowCare) .
. CD4 T-Lymphocyte Count (Unchanged from FlowCare)
. CD4 Percentage (of total Lymphocytes) (Unchanged from FlowCare)
. Monocyte Count (New parameter not on FlowCare)
. Monocyte Percentage (of White Blood Cells) (New parameter not on FlowCare)
Neutrophil Count (New parameter not on FlowCare) .
. Neutrophil Percentage (of White Blood Cells) (New parameter not on FlowCare)
Eosinophil Count (New parameter not on FlowCare) .
Eosinophil Percentage (of White Blood Cells) (New parameter not on FlowCare) .
Hemoglobin Concentration (New parameter not on FlowCare) .

The PointCare NOW System and its methods for immune hematology analysis are intended for in vitro diagnostic use in clinical laboratory settings.

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6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

The system reports it's parameters on the basis of software analysis of light scatter measurements with the use of non-fluorescent reagents. The PointCare NOW System and predicate devices are all intended for the determination of well-established parameters. All of the devices utilize anticoagulated whole blood as the initial specimen. Additionally, all of the devices employ flow-based technologies.

The PointCare NOW System is a single compact instrument whereas the predicate hematology analyzers and flow cytometers are larger, more complex systems that must be used in conjunction with each other to provide results for the twelve parameters included in this 510(k) Premarket Notification.

7. PERFORMANCE TESTING

Electrical Testing

The PointCare NOW Instrument underwent electrical safety testing and electromagnetic compatibility testing. The instrument was found to be in compliance with applicable requirements of CFR 47 Part 15 Class A, IEC 61000, UL 61010, and EN 61326.

Nonclinical Testing

A precision study was performed to assess the within-run and total precision of the PointCare NOW System by replicate measurements of control materials for three days. On each day, testing consisted of three separate runs of three replicates each with each level of control material. In addition, another precision study was performed to assess within-day precision using whole blood samples. The samples were analyzed in ten replicates each over the course of one day. Results of these studies demonstrated acceptable precision of the PointCare NOW System.

A linearity study was performed to assess the performance of the PointCare NOW System over a wide range of cell concentrations for the measured parameters. WBC count and Hemoglobin were further evaluated in the low range. The results were tested for linearity and least squares regression analysis was performed. Linearity was demonstrated in all cases.

A carryover study was performed to assess the effect of a whole blood sample on background counts in subsequent analyses for the measured parameters. Negligible carryover was observed.

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Clinical Testing

A multi-site prospective study was conducted at four investigational sites to evaluate the performance of the PointCare NOW System with other commercially available methods. A total of evaluable samples were analyzed across all participating sites. Data analyses were performed for comparison of the PointCare NOW method to the reference methods. The analyses of the pooled data showed comparable means and ranges for the PointCare NOW and reference method parameters.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 1 4 2008

PointCare Technologies, Inc. C/O Maurice N. Doire 181 Cedar Hill Street Marlborough, Massachusetts 01752

Re: K072869

Trade/Device Name: PointCare Now System Regulation Number: 21 CFR 864.5220 Regulation Name: Differential Cell Counter Regulatory Class: Class II Product Code: GKZ Dated: October 4, 2007 Received: October 9, 2007

Dear Mr. Doire:

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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket

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Page 2 – Pointcare Technologies Inc.

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), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Robt. G. Becker

Robert L. Becker, M.D., Ph.D. Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use 510(k) Number (if known): Device Name: PointCare NOW System

Indications for Use:

Whole blood samples can be analyzed with the PointCare NOW System for the following parameters:

. White Blood Cell Count
Lymphocyte Count .
Lymphocyte Percentage (of White Blood Cells) .
CD4 T-Lymphocyte Count .
CD4 Percentage (of total Lymphocytes) .
Monocyte Count ●
. Monocyte Percentage (of White Blood Cells)
Neutrophil Count .
Neutrophil Percentage (of White Blood Cells) .
Eosinophil Count .
. Eosinophil Percentage (of White Blood Cells)
Hemoglobin Concentration .

The PointCare NOW System and its methods for analysis are intended for in vitro diagnostic use in clinical laboratory settings.

Prescription Use	X	AND/OR	Over-the-Counter Use
(Part 21 CFR 801 Subpart D)			(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Division Sign-Off

PointCare Technologies, Inc. 510(k)	October 3, Office of In Vitro Diagnostic Device
PointCare NOW System	Evaluation and Safety
	510(k) K072869

Regulation Number and Section

§ 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.”