K Number

Device Name

QBC STAR CENTRIFUGAL HEMATOLOGY SYSTEM

Manufacturer

BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC

Date Cleared

1999-09-23

(30 days)

Product Code

GKZ

Regulation Number

864.5220

Intended Use

The QBC STAR™ Centrifugal Hematology System provides a diagnostic hematology profile on venous or capillary blood: hematocrit, hemoglobin, mean corpuscular hemoglobin concentration (MCHC), platelet count, white blood cell count, granulocyte count (% and number) and lymphocyte/monocyte count (% and number).

Device Description

The QBC STAR™ Centrifugal Hematology System is a self-contained, whole blood automated hematology system. Testing can be performed on venous or capillary samples. All tests are performed in the QBC STAR™ Blood Collection Tube. The system is powered by a universal voltage internal power supply that plugs directly into an AC power source. The instrument is factory preset and does not require user calibration. The methodology of the QBC STAR centrifugal hematology system is based on electro-optical linear measurements of the discrete layers of packed blood cells in a microhematocrit-type tube. The cell layering results from density gradients formed during high-speed centrifugation of the blood. Nine primary hematology values, including, hematocrit, hemoglobin, mean corpuscular hemoglobin concentration (MCHC), white blood cell count, platelet count, granulocyte count (% and number) and lymphocyte/monocyte count (% and number) are derived. QBC hematology tests utilize precision-bore glass tubes pre-coated with potassium oxalate, acridine orange fluorochrome stain and an agglutinating agent. During high-speed centrifugation of the blood-filled tube, the cells form in packed layers, according to their density, around the float, which has descended into the red blood cells. The buffy coat is automatically scanned and fluoresence and absorbance readings are made to identify the expanded layers of differentiated cells. Volumes of these packed cell layers are then computed to obtain quantitative values for the listed parameters. On the QBC STAR system, the hematocrit, white blood cell counts and the platelet count are direct measurements of the cell lavers. The hemoglobin measurement is directly related to the density of the red blood cells and based on the depth of penetration of the float into the red blood cell layer. Mean Corpuscular Hemoglobin Concentration (MCHC) is a function of hemoglobin and hematocrit and is electronically calculated according to the standard equation (Hab/Hct x 100).

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K992849

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description relies on electro-optical linear measurements and density gradients, not AI/ML algorithms for analysis.

Therapeutic

No
This device is a diagnostic hematology system used to provide a hematology profile by measuring specific parameters in blood samples (hematocrit, hemoglobin, etc.). It does not provide treatment or therapy.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states that the device "provides a diagnostic hematology profile."

SaMD (Software as a Medical Device)

The device description clearly outlines a physical system including a centrifuge, optical measurement system, and blood collection tubes, indicating it is a hardware-based device with integrated software.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The "Intended Use / Indications for Use" section explicitly states that the system "provides a diagnostic hematology profile on venous or capillary blood." This clearly indicates the device is used to perform tests on biological samples (blood) to provide diagnostic information.
Device Description: The description details how the device analyzes blood samples using centrifugation and optical measurements to determine various hematology parameters. This process is characteristic of in vitro diagnostic testing.
Sample Type: The device uses "venous or capillary blood," which are biological samples.
Output: The output is a "diagnostic hematology profile," which is information used for diagnosis.

The definition of an In Vitro Diagnostic (IVD) device is a medical device that is used to perform tests on samples such as blood, urine, or tissue to detect diseases or other conditions. The QBC STAR™ Centrifugal Hematology System fits this definition perfectly.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

GKZ

Device Description

The methodology of the QBC STAR centrifugal hematology system is based on electro-optical linear measurements of the discrete layers of packed blood cells in a microhematocrit-type tube. The cell layering results from density gradients formed during high-speed centrifugation of the blood. Nine primary hematology values, including, hematocrit, hemoglobin, mean corpuscular hemoglobin concentration (MCHC), white blood cell count, platelet count, granulocyte count (% and number) and lymphocyte/monocyte count (% and number) are derived.

QBC hematology tests utilize precision-bore glass tubes pre-coated with potassium oxalate, acridine orange fluorochrome stain and an agglutinating agent. During high-speed centrifugation of the blood-filled tube, the cells form in packed layers, according to their density, around the float, which has descended into the red blood cells. The buffy coat is automatically scanned and fluoresence and absorbance readings are made to identify the expanded layers of differentiated cells. Volumes of these packed cell layers are then computed to obtain quantitative values for the listed parameters.

On the QBC STAR system, the hematocrit, white blood cell counts and the platelet count are direct measurements of the cell lavers. The hemoglobin measurement is directly related to the density of the red blood cells and based on the depth of penetration of the float into the red blood cell layer. Mean Corpuscular Hemoglobin Concentration (MCHC) is a function of hemoglobin and hematocrit and is electronically calculated according to the standard equation (Hab/Hct x 100).

Mentions image processing

The intensity profile obtained, using 2 wavelengths of emitted light (red and green), is used to determine the beginning and the end of each cell layer.

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

Validation through accuracy testing of venous and capillary samples showed equivalent performance to the previously cleared product.

Key Metrics

Not Found

Predicate Device(s)

QBC™ AUTOREAD™ Plus Hematology System (K992849)

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

SEP 2 3 1999

510(k) SUMMARY

BECTON DICKINSON MICROBIOLOGY SYSTEMS SUBMITTED BY: 7 LOVETON CIRCLE SPARKS, MD 21152
CONTACT: Monica E. Giguere Requlatory Affairs Associate
(410) 316-4287 TELEPHONE:
PREPARED: August 20, 1999
QBC STAR™ Centrifugal Hematology System DEVICE NAME:

PREDICATE DEVICE:

QBC™ AUTOREAD™ Plus Hematology System

The QBC STAR™ Centrifugal Hematology System INTENDED USE: provides a diagnostic hematology profile on venous or capillary blood: hematocrit, hemoglobin, mean corpuscular hemoglobin concentration (MCHC), platelet count, white blood cell count, granulocyte count (% and number) and lymphocyte/monocyte count (% and number).

DEVICE DESCRIPTION:

DEVICE COMPARISON:

The QBC STAR Centrifugal Hematology System is a modification of the QBC AUTOREAD Plus System and is substantially equivalent to it. Table 1 summarizes the similarities and differences between the QBC STAR system and the modified/predicate device.

FEATURE	QBC STAR System	QBC™ AUTOREAD™ Plus
Intended Use	The QBC STAR Centrifugal
Hematology System provides
a diagnostic hematology
profile on venous or capillary
blood: Hematocrit,
Hemoglobin, Mean
Corpuscular Hemoglobin
Concentration (MCHC),
Platelet Count, White blood
cell count, Granulocyte (%
and number) and
Lymphocyte/Monocyte (% and
number).	The QBC AUTOREAD Plus
System provides a diagnostic
hematology profile on venous
or capillary blood: Hematocrit,
Hemoglobin, Mean
Corpuscular Hemoglobin
Concentration (MCHC),
Platelet Count, White blood
cell count, Granulocyte (%
and number) and
Lymphocyte/Monocyte (% and
number).
Methodology	Electro-optical linear
measurements of the discrete
layers of blood cells in a
microhematocrit-type tube.	Electro-optical linear
measurements of the discrete
layers of blood cells in a
microhematocrit-type tube.
Sample Tube	Uses the QBC™ AccuTube
enclosed in a plastic sleeve.
(a.k.a. QBC STAR™ Blood
Collection Tube)	Uses the QBC™ AccuTube. It
is not enclosed in a plastic
sleeve.
Float	Injection molded polystyrene
plastic	Injection molded polystyrene
plastic
Float Insertion	Inserted by user during
capping operation.	Inserted by user as a distinct
step.
Fill Volume	$70 \mu L \pm 5 \mu L$	$70 \mu L \pm 5 \mu L$
Closed-end stopper	Polyethylene plug with small
air vent hole that does not
require specific plug seating
step by the user. The
extruded plug has a
fluorescent dye additive so the
bottom of the red blood cells
can be located	Santoprene plug with molded-
in vents that must be seated
by the user. The injection-
molded plug also uses a
fluorescent dye additive so the
bottom of the red blood cells
can be located.
FEATURE	QBC STAR System	QBC™ AUTOREAD™ Plus
Instrument Modules	Centrifuge and analyzer are in one housing.	Centrifuge and analyzer are separate modules.
Capacity	Spins and analyzes one tube at a time.	Can spin 20 tubes at once.
Analyzes one tube at a time.
Centrifuge Cycle	Packing cycle is preceded by a mixing cycle where the rotor spins at 5000 RPM until the float reaches the bottom of the tube. The rotor then spins at 11,000 RPM for 4.75 minutes to separate and pack the blood into cell layers.	There is no mixing cycle.
The centrifuge provided with the system spins at 12,000 RPM for 5 minutes to separate and pack the blood into cell layers.
Optical Measurement Subsystem	Optical measurement system is based on capturing the intensity profile (image) of the tube in the centrifuge rotor as it rotates past the detector assembly.	Optical measurement system is based on moving the tube linearly through a fixed optical system to build an intensity profile of the tube.
Fluorescent Measurement	Electronic scan of tube:
• Region of tube illuminated by blue flash lamp
• Array of photodetectors
• Electronic sequencing of array	Mechanical scan of tube:
• Point on tube illuminated by blue incandescent lamp.
• Single detector
• Mechanical scan of tube.
Cell Layer Determination	The intensity profile obtained, using 2 wavelengths of emitted light (red and green), is used to determine the beginning and the end of each cell layer.
The intensity profile is measured at 45-degree intervals around the tube so that any variations in the length of the cell layers may be averaged.	The intensity profile obtained, using 2 wavelengths of emitted light (red and green), is used to determine the beginning and the end of each cell layer.
The intensity profile is measured at 45-degree intervals around the tube so that any variations in the length of the cell layers may be averaged.
Transmission Measurement	Electronic scan of tube:
• Region of tube illuminated by six 630nm LEDs.
• Array of photodetectors.
• Electronic sequencing of array	Mechanical scan of tube:
• Point on tube illuminated by a single 610nm LED.
• Single detector
• Mechanical scan of tube.
Blue Excitation Light Source	Xenon linear arc lamp with elliptical reflector illuminating a region of tube through a band pass filter with an average %T of 70% over a wavelength of 390nm to 490nm.	Tungsten filament lamp focused into a spot on the tube through a single aspherical lens and a band pass filter with an average %T of 45% over a wavelength of 410nm to 485nm.
Red Emission Filter	Plasma coated interference filter. The average %T is 80% over a wavelength of 610nm to 670nm.	A 610nm longpass red glass filter combined with infra-red glass blocking filter and blue blocking glass filter. The average %T is 10%.
FEATURE	QBC STAR System	QBC™ AUTOREAD™ Plus
Green emission filter	Plasma coated interference
filter. The average %T = 70%
over a wavelength of 520nm
to 570nm.	A 530 green transmitting glass
filter combined with glass
infra-red blocking and blue
blocking filters. The average
%T is 20% over a wavelength
of 530nm to 590nm.
Locating Bottom of Float	A transmittance scan is used
to locate the float bottom, 8
red fluorescent scans, 8 green
fluorescent scans are taken of
the float region of the tube.	A transmittance scan is used
to locate the float bottom, 8
red fluorescent scans, 8 green
fluorescent scans are taken of
the float region of the tube.
Identification of the Bottom of
RBCs	The instrument scans the
bottom of the sample
assembly in fluorescence
mode to pick up the
fluorescent signal from the
closed end stopper.	The instrument scans the
bottom of the sample
assembly in fluorescence
mode to pick up the
fluorescent signal from the
closed end stopper.
Fill Volume Determination	The instrument scans the
plasma area of the sample in
fluorescence mode (blue light
excitation). The meniscus
provides a large signal
transition that identifies the
top of the sample column.	The instrument scans the
plasma area of the sample in
fluorescence mode (blue light
excitation). The meniscus
provides a large signal
transition that identifies the
top of the sample column.
Identification of buffy coat
layers.	A sequence of processing the
Red and Green float scans
identifies the location of the
three layers of buffy coat cells.
This sequence uses patterns
of similarities as well as
dissimilarities in emission
color.	A sequence of processing the
Red and Green float scans
identifies the location of the
three layers of buffy coat cells.
This sequence uses patterns
of similarities as well as
dissimilarities in emission
color.
Verification of processed
sample integrity	The data scans are evaluated
to determine if the layers have
formed properly, that the
colors of the buffy coat have
the proper signal intensity and
that the patterns of these
colors follow a known set of
rules.	The data scans are evaluated
to determine if the layers have
formed properly, that the
colors of the buffy coat have
the proper signal intensity and
that the patterns of these
colors follow a known set of
rules.
Algorithms	A series of numerical
algorithms convert the volume
of measured cell material in
each layer to an equivalent
cell count.	A series of numerical
algorithms convert the volume
of measured cell material in
each layer to an equivalent
cell count.
Calibration Check	Uses internal calibration
targets to verify proper
function of the centrifuge and
optical subsystems for each
test run. The results from
each run are compared with
results stored at the time of
manufacturing.	Uses an external calibration
rod that the operator must run
on a daily basis. The results
are compared against
acceptance ranges by the user
to verify proper system
operation.

Table 1: Device Comparison - QBC STAR™ Centrifugal Hematology System vs. QBC™ AUTOREAD™ Plus System

' The term "substantial equivalence" as used in this 510(k) notification is limited to the definition of substantial equivalence as found in the Federal Food, Drug and Cosmetic Act, as amended and as applied under 21 CFR 807, Subpart E under which a device can be marketed without pre-market approval or reclassification. A determination of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws or their application by the courts

The modifications included in the QBC STAR system were assessed through risk analysis and verification tests were performed as a result of this risk analysis. The impact to the system of modifications to the sample collection tube was tested through simulated testing. The ability of the system software to appropriately reject or accept the processed samples was assessed.

Comparison of scans from multiple blood and control samples were made to determine equivalence between the new optical components and those used on the previously cleared product. Validation through accuracy testing of venous and capillary samples showed equivalent performance to the previously cleared product.

Although the QBC STAR Centrifugal Hematology System has modifications from the previously cleared QBC AUTOREAD Plus System these modifications do not present new issues of safety and effectiveness.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

SEP 2 3 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Monica E. Giguere Regulatory Affairs Associate Becton Dickinson & Company 7 Loveton Circle Sparks, Maryland 21152

K992849 Re:

Trade Name: Becton Dickinson & Company, QBC™ STAR Centrifugal Hematology System Regulatory Class: II Product Code: GKZ Dated: August 20, 1999

Received: August 24, 1999

Dear Ms. Giguere:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

This letter will allow you to begin marketing your device as described in your 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D, M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Page 1 of 1

K992849 510(k) Number (if known)

QBC STARTM Centrifugal Hematology System Device Name:

Indications For Use:

The QBC STAR Centrifingal Hematology System provides a diagnostic hematology profile on venous or capillary blood: hematocrit, hemoglobin, MCHC (Mean Corpuscular Hemoglobin Concentration, platelet count, white blood cell count, granulocyte count (% and number) and lymphocyte/monocyte count (% and number).

Pete E. Maker

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K992849

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

Concurrence of CDRH, Office of Device Evaluations (ODE)

Prescription

(Optional Format 3-10-98)