(113 days)
No
The description details a flow cytometry system using fluorescent antibodies and beads for cell counting, with no mention of AI or ML algorithms for data analysis or interpretation.
No.
The device is an in vitro diagnostic reagent intended to identify and quantify specific cell populations in peripheral blood for diagnostic purposes, not for direct therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for in vitro diagnostic use." It is used to identify and determine the percentages and absolute counts of various cell types in peripheral blood, which are diagnostic measurements.
No
The device description clearly outlines physical components (reagent, tubes, lysing solution, beads) and their interaction with a hardware system (BD FACSCanto system) for data acquisition. While software is mentioned as part of the predicate device, the core of the described device involves physical reagents and a flow cytometer.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states "intended for in vitro diagnostic use".
- Device Description: The description details how the reagent is used to analyze components of peripheral blood, which is a biological sample taken from the body.
- Function: The device is designed to identify and quantify specific cell populations in blood, providing information that can be used for diagnostic purposes.
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, conditions, or infections. This device clearly fits that description.
N/A
Intended Use / Indications for Use
BD Multitest 6-Color TBNK reagent with BD Trucount tubes is intended for in vitro diagnostic use with the BD FACSCanto system to identify and determine the percentages and absolute counts of T, B, and natural killer (NK) cells as well as the CD4 and CD8 subpopulations of T cells in peripheral blood.
Indications For Use:
- For use with the BD FACSCanto flow cytometer. .
- For use with whole blood collected in K3 EDTA tubes. .
- For use in the identification and determination of percentages and absolute . counts of T, B, and natural killer (NK) cells as well as the CD4 and CD8 subpopulations of T cells in peripheral blood.
- For in vitro diagnostic use. .
Product codes (comma separated list FDA assigned to the subject device)
GKZ
Device Description
The BD Multitest 6-Color TBNK reagent is a six-color direct immunofluorescence reagent for use with the BD FACSCanto system to identify and determine the percentages and absolute counts (using BD Trucount tubes) of T, B, and natural killer (NK) cells as well as the CD4 and CD8 subpopulations of T cells in peripheral blood.
When a known volume of whole blood is added to the reagent in a BD Trucount tube, the fluorochrome-labeled antibodies in the reagent bind specifically to leucocyte surface antigens. The stained samples are treated with BD FACS lysing solution to lyse erythrocytes, and the lyophilized pellet in the BD Trucount tube dissolves, releasing a known number of fluorescent beads.
During acquisition, the cells and beads travel past two laser beams and scatter the laser light. The stained cells and beads fluoresce at different intensities. These scatter and fluorescence signals, detected by the flow cytometer, provide information about each cell's size, internal complexity, and relative fluorescence intensity. During analysis, the absolute number (cells/uL) of positive cells in the sample can be determined by comparing cellular events to bead events.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral blood
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Substantial equivalence and the performance of BD Multitest 6-color TBNK reagent with BD Trucount tubes have been demonstrated through accuracy, precision, linearity, and sample and stain stability studies.
Accuracy: The accuracy study design was based on NCCLS document EP9-A2, Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline – Second Edition. The predicate method was BD Multitest IMK kit (K980858) on the BD FACSCanto system with BD FACSCanto clinical software (K041074).
Sample Size: n=117 for lymphocyte subset percentages and absolute counts.
Results:
Lymphocyte Subset Percentages Mean Bias (95% CI):
CD4: 0.1 (-0.1, 0.2)
CD8: -0.8 (-1.0, -0.5)
CD3: -0.2 (-0.4, 0.0)
CD19: 0.3 (0.2, 0.4)
CD16+CD56: -0.1 (-0.3, 0.0)
Lymphocyte Subset Absolute Counts Mean Bias (95% CI):
CD4: -2.7 (-4.2, -1.3)
CD8: -3.5 (-4.4, -2.6)
CD3: -1.9 (-2.6, -1.2)
CD19: 1.8 (0.3, 3.3)
CD16+CD56: -2.3 (-4.1, 0.5)
Precision: The precision study design was based on NCCLS document EP5-A, Evaluation of Precision Performance of Clinical Chemistry Devices; Approved Guideline.
Sample Size: n=42 for all subsets for both low and normal samples.
Results - Repeatability of Lymphocyte Subset Percentages (SD):
Low Sample: CD4=0.64, CD8=1.07, CD3=1.17, CD19=0.89, CD16+CD56=0.90
Normal Sample: CD4=0.95, CD8=0.65, CD3=0.86, CD19=0.62, CD16+CD56=0.61
Results - Within-Device Precision for Lymphocyte Subset Percentages (SD):
Low Sample: CD4=0.69, CD8=1.29, CD3=1.23, CD19=0.89, CD16+CD56=0.96
Normal Sample: CD4=1.23, CD8=0.81, CD3=0.90, CD19=0.62, CD16+CD56=0.62
Results - Repeatability of Lymphocyte Subset Absolute Counts (%CV):
Low Sample: CD4=7.6, CD8=4.1, CD3=4.0, CD19=5.7, CD16+CD56=7.0
Normal Sample: CD4=4.7, CD8=4.7, CD3=4.2, CD19=5.3, CD16+CD56=7.9
Results - Within-Device Precision of Lymphocyte Subset Absolute Counts (%CV):
Low Sample: CD4=8.0, CD8=5.0, CD3=4.4, CD19=6.0, CD16+CD56=8.0
Normal Sample: CD4=4.8, CD8=5.4, CD3=4.2, CD19=5.7, CD16+CD56=7.9
Linearity: The linearity study design was based on NCCLS document EP6-A, Evaluation of the Linearity of Quantitative Analytical Methods; Approved Guideline.
Results - Lymphocyte Subset Linear Ranges for Absolute Counts (cells/µL) and R2:
CD4: 4 - 2,234, R2=0.998
CD8: 158 - 1,125, R2=0.991
CD3: 498 - 3,356, R2=0.996
CD19: 71 - 447, R2=0.989
CD16+CD56: 0 - 1,559, R2=0.999
Sample and Stain Stability:
Anticoagulated blood stored at room temperature (20 – 25° C) must be stained within 24 hours of draw and then analyzed within 6 hours of staining.
Conclusion: BD Multitest 6-color TBNK reagent with BD Trucount tubes is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.”
0
510(k) Summary
This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR 807.92.
The assigned 510(k) number is ___
JUN -6 2006
Submitter Information
- Submitter: BD Biosciences 2350 Qume Drive San Jose, CA 95131
- Contact: Carter Navarro Regulatory Affairs Specialist Tel: 408.954.2469 Fax: 408.954.2495 carter navarro@bd.com
Summary Date: February 9, 2006
Device Name and Classification
| Trade Name: | BD Multitest 6-color TBNK reagent with
BD Trucount tubes |
|----------------------|-------------------------------------------------------------|
| Classification Name: | Automated Differential Cell Counter |
| Regulation Number: | 21 CFR 862.5220 |
| Product Code: | GKZ |
Substantially Equivalent Predicate Device
BD Multitest 6-color TBNK reagent with BD Trucount tubes is substantially equivalent to BD Multitest IMK kit (K980858) when used with the BD FACSCanto system with BD FACSCanto clinical software (K041074).
1
Device Description
The BD Multitest 6-Color TBNK reagent is a six-color direct immunofluorescence reagent for use with the BD FACSCanto system to identify and determine the percentages and absolute counts (using BD Trucount tubes) of T, B, and natural killer (NK) cells as well as the CD4 and CD8 subpopulations of T cells in peripheral blood.
When a known volume of whole blood is added to the reagent in a BD Trucount tube, the fluorochrome-labeled antibodies in the reagent bind specifically to leucocyte surface antigens. The stained samples are treated with BD FACS lysing solution to lyse erythrocytes, and the lyophilized pellet in the BD Trucount tube dissolves, releasing a known number of fluorescent beads.
During acquisition, the cells and beads travel past two laser beams and scatter the laser light. The stained cells and beads fluoresce at different intensities. These scatter and fluorescence signals, detected by the flow cytometer, provide information about each cell's size, internal complexity, and relative fluorescence intensity. During analysis, the absolute number (cells/uL) of positive cells in the sample can be determined by comparing cellular events to bead events.
Intended Use
BD Multitest 6-Color TBNK reagent with BD Trucount tubes is intended for in vitro diagnostic use with the BD FACSCanto system to identify and determine the percentages and absolute counts of T, B, and natural killer (NK) cells as well as the CD4 and CD8 subpopulations of T cells in peripheral blood.
2
Comparison to Predicate Device
:
:
| Characteristic | Predicate:
BD Multitest IMK Kit with
BD Trucount Tubes (K980858)
and BD FACSCanto System with
BD FACSCanto Clinical Software
(K041074) | Candidate:
BD Multitest 6-Color TBNK
Reagent with BD Trucount Tubes |
|--------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Identification and determination of
percentages and absolute counts of the
following mature human lymphocyte
subsets in erythrocyte-lysed whole
blood: T lymphocytes (CD3+,
CD3+CD4+, and CD3+CD8+), B
lymphocytes (CD3-CD19+), and NK
lymphocytes (CD3-CD16+CD56+). | Same. |
| Components
(including
Cluster Designation,
Conjugation, and
Clone) | BD Multitest
CD3/CD16+CD56/CD45/CD19
(1 vial, 50 tests)
CD3 FITC (SK7) CD16 PE (B73.1) +
CD56 PE (NCAM16.2) CD45 PerCP (2D1) CD19 APC (SJ25C1) Buffer with 0.1% sodium azide BD Multitest
CD3/CD8/CD45/CD4
(1 vial, 50 tests) CD3 FITC (SK7) CD8 PE (SK1) CD45 PerCP (2D1) CD4 APC (SK3) Buffer with 0.1% sodium azide BD FACS Lysing Solution
BD Trucount Tubes (100 tubes) | BD Multitest 6-Color TBNK Reagent
(1 vial, 50 tests) CD4 PE-Cy7 (SK3) CD8 APC-Cy7 (SK1) CD3 FITC (SK7) CD19 APC (SJ25C1) CD16 PE (B73.1) +
CD56 PE (NCAM16.2) CD45 PerCP-Cy5.5 (2D1) Buffer with 0.1% sodium
azide BD Trucount Tubes (50 tubes)
BD FACS Lysing Solution
(not included with reagent) |
:
:
3
| Characteristic | Predicate:
BD Multitest IMK Kit with
BD Trucount Tubes (K980858 )
and BD FACSCanto System with
BD FACSCanto Clinical Software
(K041074) | Candidate:
BD Multitest 6-Color TBNK
Reagent with BD Trucount Tubes |
|--------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|
| Specificity | Specificities of antibodies have been
verified by the International Workshop
on Human Leukocyte Differentiation
Antigens. 1,2,3,4,5,6 | Same. |
| Method to Identify
Populations of
Interest | Lyse/no-wash method using a two-tube
panel with four-color antibody reagents
(one tube stained with
CD3/CD16+CD56/CD45/CD19, the
other with CD3/CD8/CD45/CD4) to
identify lymphocytes with specific cell-
surface antigens, fluorescence
triggering, and CD45 vs. SSC for
gating. Uses fluorescent beads to
quantify absolute counts. | Same, except uses a one-tube panel
with six-color antibody reagent. |
3 Ritz J, Trinchieri G, Lanier LL. NK-cell antigens: section report. In: Schlossman SF, Bournsell L, Gilks W, et al, eds. Leucocyte Typing V: White Cell Differentiation Antigens. New York, NY: Oxford University Press; 1995;2:1367-1372.
4 Cobbold SP, Hale G, Waldmann H. Non-lineage, LFA-1 family, and leucocyte common antigens: new and previously defined clusters. In: McMichael AJ, ed. Leucocyte Typing III: White Cell Differentiation Antigens. New York, NY: Oxford University Press; 1987:788-803.
5 Bernard A, Boumsell L, Hill C. Joint report of the first international workshop on human leucocyte differentiation antigens by the investigators of the participating laboratories: T2 protocol. In: Bernard A, Boumsell L, Dausset J, Milstein C, Schlossman SF, eds. Leucocyte Typing. New York, NY: Springer-Verlag; 1984:25-60.
6 Nadler LM. B Cell/Leukemia Panel Workshop: summary and comments. In: Reinherz EL, Haynes BF, Nadler LM, Bernstein ID, eds. Leukocyte Typing II: Human B Lymphocytes. New York, NY: Springer-Verlag; 1986;2:3-43.
4 Haynes BF. Summary of T-cell studies performed during the Second International Workshop and Conference on Human Leukocyte Differentiation Antigens. In: Reinherz EL, Haynes BF, Nadler LM, Bernstein ID, eds. Leukocyte Typing II: Human T Lymphocytes. New York, NY: Springer-Verlag; 1986;1:3-30.
2 Schmidt RE. Non-lineage/natural killer section report: new and previously defined clusters. In: Knapp W, Dörken B, Gilks WR, et al, eds. Leucocyte Typing IV: White Cell Differentiation Antigens. New York, NY: Oxford University Press; 1989:517-542.
4
| Characteristic | Predicate:
BD Multitest IMK Kit with
BD Trucount Tubes (K980858)
and BD FACSCanto System with
BD FACSCanto Clinical Software
(K041074) | Candidate:
BD Multitest 6-Color TBNK
Reagent with BD Trucount Tubes |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Control | Recommend use of commercially
available whole blood control with
established values for subset
percentages and absolute counts. | Recommend use of two levels of
commercially available whole blood
controls with established values for
subset percentages and absolute
counts.
BD specifically recommends the use
of BD Multi-Check and BD Multi-
Check CD4 Low controls. |
| Instrument and
Software | BD FACSCanto flow cytometer with
BD FACSCanto clinical software
version 1.0. | Same, except uses version 2.0 of BD
FACSCanto clinical software. |
| System Setup | BD FACSCanto flow cytometer with
BD FACSCanto clinical software
version 1.0 and
BD FACS 7-color setup beads. | Same, except uses version 2.0 of BD
FACSCanto clinical software. |
| Sample and Stain
Stability | Anticoagulated blood stored at room
temperature (20-25°C) must be stained
within 48 hours of draw and then
analyzed within 24 hours of staining. | Anticoagulated blood stored at room
temperature (20-25°C) must be
stained within 24 hours of draw and
then analyzed within 6 hours of
staining. |
| Results | CD3+, CD3+CD4+, and CD3+CD8+ T
lymphocytes; CD3-CD19+ B
lymphocytes, and CD3-CD16+CD56+
NK lymphocytes expressed as
percentages of total lymphocytes or as
absolute counts (cells/\u03bcL) in whole
blood. | Same. |
| Sample Type | Erythrocyte-lysed whole blood,
collected in K3 EDTA blood collection
tubes. | Same. |
. ・・・・・・・・
.
5
Summary of Performance Data
Substantial equivalence and the performance of BD Multitest 6-color TBNK reagent with BD Trucount tubes have been demonstrated through accuracy, precision, linearity, and sample and stain stability studies.
Accuracy
The accuracy study design was based on NCCLS document EP9-A2, Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline – Second Edition. The predicate method was BD Multitest IMK kit (K980858) on the BD FACSCanto system with BD FACSCanto clinical software (K041074).
| Lymphocyte
Subset | n | Mean Bias (%)
(95% CI) | Range for Test System
(%)
(Predicate System) |
|----------------------|-----|---------------------------|----------------------------------------------------|
| CD4 | 117 | 0.1
(-0.1, 0.2) | 0.51 - 66.86
(0.81 - 68.67) |
| CD8 | 117 | -0.8
(-1.0, -0.5) | 10.77 - 83.43
(10.91 -83.09) |
| CD3 | 117 | - 0.2
(-0.4, 0.0) | 33.81 - 88.45
(33.12-89.51) |
| CD19 | 117 | 0.3
(0.2, 0.4) | 0.1 - 35.89
(0.08-35.77) |
| CD16+CD56 | 117 | -0.1
(-0.3, 0.0) | 2.44 - 51.47
(3.04 - 50.84) |
Lymphocyte Subset Percentages
. . . . . .
6
| Lymphocyte
Subset | n | Mean Bias (%)
(95% CI) | Range for Test System (cells/µL)
(Predicate System) |
|----------------------|-----|---------------------------|--------------------------------------------------------|
| CD4 | 117 | -2.7
(-4.2, -1.3) | 4.39 - 1592.79
(6.23 - 1590.7) |
| CD8 | 117 | -3.5
(-4.4, -2.6) | 50.79 - 2416.16
(57.91 - 2194.02) |
| CD3 | 117 | -1.9
(-2.6, -1.2) | 107.14 - 3403.08
(108.74 - 3231.05) |
| CD19 | 117 | 1.8
(0.3, 3.3) | 0.5 - 1207.49
(0.42 - 1199.38) |
| CD16+CD56 | 117 | -2.3
(-4.1, 0.5) | 6.7 - 918.43
(7.94 - 955) |
Lymphocyte Subset Absolute Counts
Precision
The precision study design was based on NCCLS document EP5-A, Evaluation of Precision Performance of Clinical Chemistry Devices; Approved Guideline.
| Lymphocyte Subset | n | Low Sample7
SD | Normal Sample8
SD |
|-------------------|----|-------------------|----------------------|
| CD4 | 42 | 0.64 | 0.95 |
| CD8 | 42 | 1.07 | 0.65 |
| CD3 | 42 | 1.17 | 0.86 |
| CD19 | 42 | 0.89 | 0.62 |
| CD16+CD56 | 42 | 0.90 | 0.61 |
Repeatability of Lymphocyte Subset Percentages
7 Streck CD-Chex Plus CD4 Low controls.
8 Streck CD-Chex Plus controls.
7
| Lymphocyte Subset | n | Low Sample
SD | Normal Sample
SD |
|-------------------|----|------------------|---------------------|
| CD4 | 42 | 0.69 | 1.23 |
| CD8 | 42 | 1.29 | 0.81 |
| CD3 | 42 | 1.23 | 0.90 |
| CD19 | 42 | 0.89 | 0.62 |
| CD16+CD56 | 42 | 0.96 | 0.62 |
Within-Device Precision for Lymphocyte Subset Percentages
Repeatability of Lymphocyte Subset Absolute Counts
| Lymphocyte Subset | n | Low Sample
%CV | Normal Sample
%CV |
|-------------------|----|-------------------|----------------------|
| CD4 | 42 | 7.6 | 4.7 |
| CD8 | 42 | 4.1 | 4.7 |
| CD3 | 42 | 4.0 | 4.2 |
| CD19 | 42 | 5.7 | 5.3 |
| CD16+CD56 | 42 | 7.0 | 7.9 |
Within-Device Precision of Lymphocyte Subset Absolute Counts
| Lymphocyte Subset | n | Low Sample
%CV | Normal Sample
%CV |
|-------------------|----|-------------------|----------------------|
| CD4 | 42 | 8.0 | 4.8 |
| CD8 | 42 | 5.0 | 5.4 |
| CD3 | 42 | 4.4 | 4.2 |
| CD19 | 42 | 6.0 | 5.7 |
| CD16+CD56 | 42 | 8.0 | 7.9 |
:
·
8
Linearity
The linearity study design was based on NCCLS document EP6-A, Evaluation of the Linearity of Quantitative Analytical Methods; Approved Guideline. Concentration levels were established based on an expected CD4+ range of 200 to 3,000 cells/uL.
| Lymphocyte
Subset | Linear Range
(cells/µL) | R2 |
|----------------------|----------------------------|-------|
| CD4 | 4 - 2,234 | 0.998 |
| CD8 | 158 - 1,125 | 0.991 |
| CD3 | 498 - 3,356 | 0.996 |
| CD19 | 71 - 447 | 0.989 |
| CD16+CD56 | 0 - 1,559 | 0.999 |
Lymphocyte Subset Linear Ranges for Absolute Counts
Sample and Stain Stability
Whole blood should be collected aseptically by venipuncture using K3 EDTA blood collection tubes. Anticoagulated blood stored at room temperature (20 – 25° C) must be stained within 24 hours of draw and then analyzed within 6 hours of staining.
Conclusions from Performance Data
BD Multitest 6-color TBNK reagent with BD Trucount tubes is substantially equivalent to the predicate device.
9
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, with stylized lines forming the body and wings.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN -6 2006
BD Biosciences c/o Mr. Carter Navarro Regulatory Affairs Specialist 2350 Qume Dr. San Jose, CA 95131-1807
Re: K060375
Trade/Device Name: BD Multitest 6-color TBNK reagent with BD Trucount tubes Regulation Number: 21 CFR 864.5220 Regulation Name: Automated Differential Cell Counter Regulatory Class: Class II Product Code: GKZ Dated: February 10, 2006 Received: February 13, 2006
Dear Mr. Navarro:
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 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 CFR Part 807); labeling (21 CFR Part 801); 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.
10
Page 2 -
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,
Marie, than for
Dr. Robert Becker
Robert L. Becker, Jr., M.D., Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
11
Indications for Use Statement
510(k) Number: K060375
Device Name: BD Multitest 6-color TBNK reagent with BD Trucount tubes
Indications For Use:
- For use with the BD FACSCanto flow cytometer. .
- For use with whole blood collected in K3 EDTA tubes. .
- For use in the identification and determination of percentages and absolute . counts of T, B, and natural killer (NK) cells as well as the CD4 and CD8 subpopulations of T cells in peripheral blood.
- For in vitro diagnostic use. .
X Prescription Use _ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE OF NEEDED
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Maria Chan for
Josephine Bautista
DIVISION SIGN-OFF
Office of In Vitro Diagnostic
Device Evaluation and Safety
51000 K260375
Page 1 of ____________________________________________________________________________________________________________________________________________________________________