BD FACSCOUNT CD4 REAGENTS WITH MODEL 339010

• K Number: K081213
• Device Name: BD FACSCOUNT CD4 REAGENTS WITH MODEL 339010
• Manufacturer: BD Biosciences
• Date Cleared: 2008-08-14 ( 106 days)
• Product Code: GKZ
• Regulation Number: 864.5220

Intended Use

BD FACSCount CD4 reagents are used to enumerate the absolute counts of CD4 T lymphocytes and determine the percentage of lymphocytes that are CD4 T lymphocytes in unlysed whole blood (CD4 count and CD4 percentage). The reagents are for in vitro diagnostic use on a BD FACSCount instrument.

Device Description

BD FACSCount CD4 reagents are intended for use in enumerating the absolute counts of CD4 T lymphocytes and the percentage of lymphocytes that are CD4 T lymphocytes in unlysed whole blood using the BD FACSCount instrument system. The product offers a single test that requires one convenient, ready-to-use reagent tube labeled CD4. It is intended for use on a BD FACSCount instrument. The reagent kit consists of the following components: 50 reagent tubes of CD4 PE/CD14 PE-Cy5/CD15 PE-Cy5/fluorescent nuclear dye and counting reference beads, 65 reagent tube caps, One 5-mL vial of 5% formaldehyde in phosphate-buffered saline (PBS), used as fixative solution.

Predicate Devices

K071143, K071141

Reference Devices

K071143, K071141

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a flow cytometry reagent kit and instrument system for enumerating CD4 T lymphocytes. There is no mention of AI, ML, or any computational methods beyond standard data analysis for calculating counts and percentages. The performance studies focus on traditional analytical validation metrics like method comparison, precision, and linearity.

Therapeutic

No
The device is an in vitro diagnostic reagent used to enumerate specific cell types (CD4 T lymphocytes) in blood samples. It is used for diagnostic purposes and does not directly treat or alleviate a condition.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the reagents "are for in vitro diagnostic use". Diagnosis involves identifying or enumerating specific health markers, which this device does by counting CD4 T lymphocytes.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the device is a "reagent kit" consisting of physical components (reagent tubes, caps, fixative solution) intended for use with a specific hardware instrument (BD FACSCount instrument). It is not a software-only device.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

• Explicit Statement in Intended Use: The "Intended Use / Indications for Use" section clearly states: "The reagents are for in vitro diagnostic use on a BD FACSCount instrument."
• Explicit Statement in Device Description: The "Device Description" section also states: "BD FACSCount CD4 reagents are intended for use in enumerating the absolute counts of CD4 T lymphocytes and the percentage of lymphocytes that are CD4 T lymphocytes in unlysed whole blood using the BD FACSCount instrument system." This describes a test performed outside of the body (in vitro) on a biological sample (whole blood) to provide diagnostic information (CD4 counts and percentages).

These explicit statements, along with the description of the reagents and their use in analyzing blood samples, definitively classify this device as an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

BD FACSCount CD4 reagents are used to enumerate the absolute counts of CD4 T lymphocytes and determine the percentage of lymphocytes that are CD4 T lymphocytes in unlysed whole blood (CD4 count and CD4 percentage). The reagents are for in vitro diagnostic use on a BD FACSCount instrument.

Product codes

GKZ

Device Description

BD FACSCount CD4 reagents are intended for use in enumerating the absolute counts of CD4 T lymphocytes and the percentage of lymphocytes that are CD4 T lymphocytes in unlysed whole blood using the BD FACSCount instrument system. The product offers a single test that requires one convenient, ready-to-use reagent tube labeled CD4. It is intended for use on a BD FACSCount instrument.

The reagent kit consists of the following components:

• 50 reagent tubes of CD4 PE/CD14 PE-Cy5/CD15 PE-Cy5/fluorescent nuclear dye and . counting reference beads
• . 65 reagent tube caps
• One 5-mL vial of 5% formaldehyde in phosphate-buffered saline (PBS), used as fixative . solution

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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

Equivalency for the candidate product has been demonstrated through method comparison, precision, linearity stain stability, and reagent stability studies.

A) Summary of Method Comparison study results:
Parameter: CD4 Absolute Count (cells/uL), n: 101, R2: 0.981, Slope: 0.971, Intercept: 12.695
Parameter: CD4 Percentage (%), n: 99, R2: 0.99, Slope: 0.999, Intercept: -0.391

B) Summary of System Precision study results:
Within-device and within-run precision of CD4 absolute counts (cells/uL)
Low control CV (cell/ul):
Within device: 4.82
Within run: 4.04
Normal control CV (cells/ul):
Within device: 4.28
Within run: 3.46

Within-device and within-run precision of CD4 percentage (cells/uL)
Low control CV (cell/ul):
Within device: 0.38
Within run: 0.35
Normal control CV (cells/ul):
Within device: 1.28
Within run: 1.15

C) Summary of System Linearity study results:
Linearity was assessed and observed to be linear within the reportable CD4+ absolute count range (50 - 5000 cells/ul).

D) Summary of Stained Sample Stability (Age of Stain) study:
Age of blood and age of stained sample were assessed and observed to be stable up to 24 hours of age of blood and up to 48 hours of age of stain.

E) Summary of Reagent Stability (Shelflife) study:
Reagents were assessed and the Kit was observed to be stable up to 15 month. Expiration dating may be extended in the future if ongoing product stability testing supports the extension.

Key Metrics

Not Found

Predicate Device(s)

K071143, K071141

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.”

Summary

0

Kofi2i3

510(k) Summary

1.0: Submitted By:

AUG 1 4 2008

BD Biosciences 2350 Qume Drive San Jose, CA 95131

Contact: Nobuko Nakajima Senior Regulatory Specialist [phone] [phone] (FAX) nobuko [e-mail]

Submission Date: April 28, 2008

2.0: Device Name:

• a) BD FACSCount™ CD4 Reagents b) 21CFR 862.5220Automated Differential Cell Counter (GKZ Class II)

3.0: Intended Use:

BD FACSCount CD4 reagents are used to enumerate the absolute counts of CD4 T lymphocytes and determine the percentage of lymphocytes that are CD4 T lymphocytes in unlysed whole blood (CD4 count and CD4 percentage). The reagents are for in vitro diagnostic use on a BD FACSCount instrument.

4.0: Basic description of the device:

BD FACSCount CD4 reagents are intended for use in enumerating the absolute counts of CD4 T lymphocytes and the percentage of lymphocytes that are CD4 T lymphocytes in unlysed whole blood using the BD FACSCount instrument system. The product offers a single test that requires one convenient, ready-to-use reagent tube labeled CD4. It is intended for use on a BD FACSCount instrument.

The reagent kit consists of the following components:

• 50 reagent tubes of CD4 PE/CD14 PE-Cy5/CD15 PE-Cy5/fluorescent nuclear dye and . counting reference beads
• . 65 reagent tube caps
• One 5-mL vial of 5% formaldehyde in phosphate-buffered saline (PBS), used as fixative . solution

5.0: Predicate Device:

BD FACSCount CD4 Reagents is substantially equivalent to BD Tritest CD3/CD4/CD45 with and without BD Trucount absolute count tubes (K071143 and K071141) for the enumerating the absolute counts of CD4 T lymphocytes and the percentage of lymphocytes that are CD4 T lymphocytes in unlysed whole blood.

BD Biosciences Premarket Notification BD FACSCount CD4 Reagents

1

6.0 Comparison to the Predicate:

| Characteristic | BD TriTEST CD3/CD4/CD45 with and
without BD Trucount absolute count
tubes on BD FACSCalibur
(Predicate) | BD FACSCount CD4 Reagents on
BD FACSCount
(New) |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | BD TriTEST CD3/CD4/CD45 is a three
color direct immunofluorescence reagent
for use with a suitably equipped flow
cytometer to identify and determine the
percentages and absolute counts of mature
human T lymphocytes (CD3+),
helper/inducer (CD3+CD4+) T
lymphocytes in erythrocyte lysed whole
blood. When used with BD Trucount
tubes, absolute counts of these populations
can be enumerated from a single tube.
This BD Tritest reagent and BD Trucount
tubes can be used with the BD
FACSLoader. The reagent can be used
with or without an isotype control. | BD FACSCount CD4 Reagents are two
color direct immunofluorescence reagent
for identifying and determining absolute
counts in cells/ul and percentage of
CD4+ T lymphocytes in unlysed whole
blood. |
| Device
classification and
product code | Class II
81 GKZ
Regulation 21 CFR §864.5220 | Same |
| Reagent | BD TriTEST
CD3FITC/CD4PE/CD45PerCP | BD FACSCount CD4 Reagents
CD4PE/CD14PE-
Cy5/CD15PECy5/fluorescent nuclear dy |
| Absolute count
beads | Trucount Absolute Count beads | Known number of reference beads
included in reagent |
| ControlBeads | None | BD FACSCount Controls
(low/mid/high) |
| Sample type | Whole blood preserved with EDTA,
heparin, or ACD-Solution A | Whole blood preserved with EDTA
only |
| System electronics | Analog | Same |
| Fluorescence Scale
(Display) | Calibur 1024 log scale or 104 linear scale | N/A - Customer does not see the dot-
plot |
| Cytometer setup | Uses FACSComp software with BD
CalibriteTM Beads to set up FL2. | None – no customer set up required |
| Sample Analysis: | Automatic analysis. User is able to adjust
the gating to optimize. | Automatic analysis with no user
intervention |
| Dynamic Range | 68 - 7.2x103 cells/ul CD4/CD3 positive
cells | CD4 absolute count of: 50-5000cells/ul
CD4 percentage of : 5-65% |
| Results | Samples are reported as CD4/CD3
positive cells/ul and CD4/CD3 %
positives of Lymphocytes | Samples are reported as CD4 cells/ul
and CD4% of Lymphocytes |

Similarities and Differences:

2

7.0: Summary of Performance Data:

Equivalency for the candidate product has been demonstrated through method comparison, precision, linearity stain stability, and reagent stability studies.

A) Summary of Method Comparison study results:

Parameter	n	R2	Slope	Intercept
CD4 Absolute Count (cells/uL)	101	0.981	0.971	12.695
CD4 Percentage (%)	99	0.99	0.999	-0.391

B) Summary of System Precision study results:

Within-device and within-run precision of CD4 absolute counts (cells/uL)
	Comments of the Real Call College of the Children and Children and

| | Low control CV
(cell/ul) | Normal control CV
(cells/ul) |
|---------------|-----------------------------|---------------------------------|
| Within device | 4.82 | 4.28 |
| Within run | 4.04 | 3.46 |

Within-device and within-run precision of CD4 percentage (cells/uL)

| | Low control CV
(cell/ul) | Normal control CV
(cells/ul) |
|---------------|-----------------------------|---------------------------------|
| Within device | 0.38 | 1.28 |
| Within run | 0.35 | 1.15 |

C) Summary of System Linearity study results:

Linearity was assessed and observed to be linear within the reportable CD4+ absolute count range (50 - 5000 cells/ul).

D) Summary of Stained Sample Stability (Age of Stain) study:

Age of blood and age of stained sample were assessed and observed to be stable up to 24 hours of age of blood and up to 48 hours of age of stain.

E) Summary of Reagent Stability (Shelflife) study:

Reagents were assessed and the Kit was observed to be stable up to 15 month. Expiration dating may be extended in the future if ongoing product stability testing supports the extension.

This Summary of safety and effectiveness is being submitted in accordance with the requirements of compliance with SMDA 1990 and 21 CFR807.92.

3

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 1 4 2008

BD Biosciences c/o Mr. Nobuko Nakajima Senior Regulatory Affairs Specialist 2350 Qume Drive San Jose, CA 95131

Re: K081213

Trade/Device Name: BD FACSCount™ CD4 Reagents Regulation Number: 21 CFR 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: GKZ Dated: July 30, 2008 Received: July 31, 2008

Dear Mr. Nakajima:

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 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.

4

Page 2

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 [phone]. 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 [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

m chan

Maria M. Chan, Ph.D. Acting Division Director Division of Immunology and Hematology Devices 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): K081213

Device Name: BD FACSCount™ CD4 Reagents

Indications for Use:

BD FACSCount CD4 reagents are used to enumerate the absolute counts of CD4 T lymphocytes and determine the percentage of lymphocytes that are CD4 T lymphocytes in unlysed whole blood (CD4 count and CD4 percentage). The reagents are for in vitro diagnostic use on a BD FACSCount instrument.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

ﺗﻢ ﺍ

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Moria M Chan
Division Sign-Off

Office of In Vitro Diganostic Device Evaluation and Safety

Kafr/2-13