(183 days)
No
The device description and performance studies focus on the physical properties and stability of beads used for counting in flow cytometry, with no mention of AI or ML algorithms for data analysis or interpretation.
No.
The device is used to check the reproducibility and accuracy of volumetric pipetting of blood samples in conjunction with in vitro diagnostic (IVD) reagents for immunophenotyping, not to directly treat a medical condition.
No
This device is described as an accessory to in vitro diagnostics (TriTEST reagents) to allow computation of positive cells per known volume of blood. It is used to check reproducibility and accuracy, not to diagnose a condition itself.
No
The device description clearly states that the device consists of "fluorescent particles supplied as a pellet in a tube" and "fluorescent particles supplied as suspensions in three bead concentrations". These are physical components, not software.
Based on the provided text, here's the analysis:
Is this device an IVD (In Vitro Diagnostic)?
Yes.
Here's why:
- Explicitly Stated Intended Use: The "Intended Use / Indications for Use" section clearly states that the TRUCOUNT Absoluce Count Tubes are intended for use as an accessory to TriTEST in vitro diagnostics. It also mentions their use with IVD immunophenotyping reagents.
- Accessory to IVD: The device is designed to be used in conjunction with other devices that are explicitly identified as IVDs (TriTEST reagents). Accessories to IVDs are generally considered part of the IVD system.
- Measurement of Biological Parameters: The device is used to compute "positive cells per known volume of blood," which is a measurement of a biological parameter in a sample taken from the human body.
- Flow Cytometry: The method of analysis, flow cytometry, is a common technique used in in vitro diagnostics for analyzing cells in biological samples.
Therefore, the TRUCOUNT Absolute Count Tubes and TRUCOUNT Counting Control Beads, as described, function as components of an in vitro diagnostic system used for analyzing blood samples.
N/A
Intended Use / Indications for Use
TRUCOUNT Absoluce Count Tubes are intended for use as an accessory to TriTEST in vitro diagnostics, such as that described in K965053 (CD3/CD4/CD45), to allow computation of positive cells per known volume of blood, using flow cytometty.
The TRUCOUNT Counting Control Beads are provided in three levels, and are intended to provide a means to check the reproducibility and accuracy of volumeric pipetting of blood samples. They are an accessory to TriTEST reagens, when used with TRUCOUNT Absolute Count Tubes to obtain absolute counts of positive cells using flow cytomerry.
Indications for Use
- For erythrocyte lysed whole blood .
- For use with FACS Loader ●
- For use with IVD immunophenotyping reagents .
- For use on flow cytometers with designated detection ranges ●
Product codes (comma separated list FDA assigned to the subject device)
GKZ
Device Description
TRUCOUNT Absolute Count Tubes are fluorescent particles supplied as a peller in a rube. The peller contains a known number of beads. A blood sample of known volume is added to the rube. Then the appropriate reagent is added to the mixture. By comparing the number of positive cell events to the number of bead events in the flow cytomerry data ourpur, posicive cells per unit volume of blood sample can be computed.
TRUCOUNT Counting Control Beads are fluorescent particles supplied as suspensions in three bead concentrations, High, Medium and Low. The fluorescence of these beads is similar to that of the Absolute Count Tube in FL1 and FL3, but is different in FL2, so that both beads may be run in the same sample, and distinguished from one another. Control beads are added to samples of normal blood prepared with TriTEST reagents and Absolute Count Tubes. The Concrol Bead count is obtained by comparison to the count of the Absolute Count Tubes. These experimental counts are compared to the expected count on the Control Bead label, to check the accuracy of pipetting.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance of the product was established by testing at Becton Dickinson Immunocytomerry Systems laboratories in San Jose, California.
- Stability of the Absolure Count Tube and Counting Control Bead was assessed and found to be . acceptable to support a one year and six month shelf life, respectively.
- Accuracy and reproducibility of the Counting Control Beads was determined and found to be . acceptable to support the ranges for acceptable performance cited in the Package Insert.
- Absolute Count Tubes were found to remain stable after the foil pouch is opened, as long as the . pouch is stored closed at room temperature, and the desiccant remains blue.
- The Absolute Count Tubes and Counting Control Beads were seen to function as expected when . used with the FACS Loader, as well as manually.
The results of the studies demonstrate that:
- Expiration dating claim for the TRUCOUNT Absolute Count Tube Product is one year. .
- Expiration dating claim for the TRUCOUNT Counting Control Beads is six months. .
- TRUCOUNT Absolute Count Tube and TRUCOUNT Counting Control Bead Product may be . used with the FACS Loader.
The product does not change the subsrantial equivalence of the reagents it is used with, as demonstrated in the respective reagent submissions.
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.
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
Attachment D Summary of Safety & Effectiveness
AUG 26 1997
Submitter Information (21 CFR 807.92(a)(1))
| Submitter: | Becton Dickinson Immunocytometry Systems |
|---|---|
| 2350 Qume Drive | |
| San Jose, CA 95131-1807 |
Anna Longwell, Esq. Contact: Director, Regulatory Affairs - Corporate (408) 954-2254
Summary Date: February 24, 1997
Name of Device and Classification (21 CFR 807-92(2)(2))
TRUCOUNT TM Absolute Count Tubes Name:
TRUCOUNTTM Counting Control Beads
Classification: Accessories to a Class II Product, Lymphocyte immunophenoryping reagent
Predicate Device (21 CFR 807,92(a)(3))
Lymphocyre immunophenotyping reagents, when used for absolute counts are subscantially equivalent to Simultest TM reagents, cleared in the Simultest IMK-Lymphocyce Kic, (K913192), plus ADCC, or, in the case of TriTEST™ reagents CD3/CD4/CD45 and CD3/CD8/CD45, to FACSCount, K933486. The absolute count application is the subject of current lymphocyte immunophenotyping reagent submissions.
Description of the Device (21 CFR 807.92(a)(4))
TRUCOUNT Absolute Count Tubes are fluorescent particles supplied as a peller in a rube. The peller contains a known number of beads. A blood sample of known volume is added to the rube. Then the appropriate reagent is added to the mixture. By comparing the number of positive cell events to the number of bead events in the flow cytomerry data ourpur, posicive cells per unit volume of blood sample can be computed.
TRUCOUNT Counting Control Beads are fluorescent particles supplied as suspensions in three bead concentrations, High, Medium and Low. The fluorescence of these beads is similar to that of the Absolute Count Tube in FL1 and FL3, but is different in FL2, so that both beads may be run in the same sample, and distinguished from one another. Control beads are added to samples of normal blood prepared with TriTEST reagents and Absolute Count Tubes. The Concrol Bead count is obtained by comparison to the count of the Absolute Count Tubes. These experimental counts are compared to the expected count on the Control Bead label, to check the accuracy of pipetting.
1
Summary of Safety and Effectiveness
Intended Use (21 CFR 807.92(a)(5))
TRUCOUNT Absoluce Count Tubes are intended for use as an accessory to TriTEST in vitro diagnostics, such as that described in K965053 (CD3/CD4/CD45), to allow computation of positive cells per known volume of blood, using flow cytometty.
The TRUCOUNT Counting Control Beads are provided in three levels, and are intended to provide a means to check the reproducibility and accuracy of volumeric pipetting of blood samples. They are an accessory to TriTEST reagens, when used with TRUCOUNT Absolute Count Tubes to obtain absolute counts of positive cells using flow cytomerry.
Indications for Use
- For erythrocyte lysed whole blood .
- For use with FACS Loader ●
- For use with IVD immunophenotyping reagents .
- For use on flow cytometers with designated detection ranges ●
Clinical Utility
The determination of absolute counts of subtypes of lymphocytes has been found useful in monitoring some forms of immunodeficiency and autoimmune disease.
Comparison to Predicate Device (21 CFR 807-92(a)(6))
Use of the TRUCOUNT Absolute Count Tubes with each of the TriTEST reagents was compared to either FACSCount, K933486 (for CD3/CD4/CD45 and CD3/CD45), or to the appropriate vial of IMK-Lymphocyte, K913192, plus ADCC. Substantial equivalence of the beads when used with other flow cytomerry reagents is included in the respective reagent submission (e.g., TriTEST CD3/CD4/CD45, K965053). Data for these comparisons is not included in this submission.
Use of the TRUCOUNT Counting Control Beads does not change the safety and effectiveness of the above assays.
Performance Data (21 CFR 807.92(b)(2))
Performance of the product was established by testing at Becton Dickinson Immunocytomerry Systems laboratories in San Jose, California.
- Stability of the Absolure Count Tube and Counting Control Bead was assessed and found to be . acceptable to support a one year and six month shelf life, respectively.
- Accuracy and reproducibility of the Counting Control Beads was determined and found to be . acceptable to support the ranges for acceptable performance cited in the Package Insert.
- Absolute Count Tubes were found to remain stable after the foil pouch is opened, as long as the . pouch is stored closed at room temperature, and the desiccant remains blue.
- The Absolute Count Tubes and Counting Control Beads were seen to function as expected when . used with the FACS Loader, as well as manually.
2
2
Summary of Safety and Effectiveness
Performance Dara-Conclusions (21 CFR 807,92(b)(3))
The results of the studies demonstrate that:
- Expiration dating claim for the TRUCOUNT Absolute Count Tube Product is one year. .
- Expiration dating claim for the TRUCOUNT Counting Control Beads is six months. .
- TRUCOUNT Absolute Count Tube and TRUCOUNT Counting Control Bead Product may be . used with the FACS Loader.
The product does not change the subsrantial equivalence of the reagents it is used with, as demonstrated in the respective reagent submissions.
: :
3
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Anna Longwell, Esq. Director, Regulatory Affairs-Corporate Becton Dickinson Immunocytometry Systems 2350 Qume Drive San Jose, California 95131-1807 AUG 26 1997 Re : K970836/S2 Becton Dickinson TruCount™ Absolute Count Tubes and Trade Name: TruCount™ Counting Control Beads Requlatory Class: II Product Code: GKZ Dated: June 5, 1997 Received: June 10, 1997
Dear Ms. Longwell:
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 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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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.
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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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Butman
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
5
Page 1 of 1
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ Device Name: Incuquant for bout to Count Tubes program Counting Control Sends
Indications For Use:
- For use with FACS Loader �
- For use with in vitro diagnostic immunophenotyping reagents �
- For use in erythrocyte lysed whole blood �
- For use to obtain absolute counts by flow cytometry ◆
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
| Division Sign |
|---|
| Division of Clinical Chemistry Devices |
| 510(k) Number |
| Prescription Use | ✓ |
|---|---|
| (Per 21 CFR 801.109) |
OR
| Over-The-Counter Use |
|---|
| (Optional Format 1-2-96) |