(43 days)
BD Tritest CD3 FITC/CD4 PE/CD45 PerCP is a three-color direct immunofluorescence reagent for identifying and enumerating percentage of mature human T lymphocytes (CD3+) and T-helper/inducer (CD3+CD4+) cells in erythrocyte-lysed whole blood (LWB).
The BD TriTEST™ CD3FITC/CD4PE/CD45 PerCP reagent is a three-color, direct immunofluorescence reagent for identifying and enumerating percentages of T lymphocytes (CD3+) and T-helper/inducer (CD3+CD4+) cells in erythrocyte-lysed whole blood (LWB). If used with Becton Dickinson flow cytometers, the product can be used with MultiSET™ software for analysis as an accessory, or customers may perform analysis using CELLQuest™ , CELLQuest Pro "" or LYSYS™ II software. The reagent vials and counting bead vials are packaged separately. Each vial of this reagent yields 50 tests. Each package of counting bead tubes yields 50 tests.
The provided text is a 510(k) summary for the BD™ TriTEST CD3/CD4/CD45 reagent. The submission is not for a new device but for a modification to an existing, legally marketed device (BD™ TriTEST CD3/CD4/CD45, K946055/S2). The modification only seeks to extend the sample stability claim for EDTA whole blood from 48 to 72 hours.
Therefore, the provided document does not contain the detailed information required to fully answer all aspects of your request, particularly regarding specific performance metrics, sample sizes for test and training sets, expert qualifications, or ground truth establishment in the way you might expect for a de novo device submission or a study evaluating a complex algorithm.
However, based on the information provided, here's what can be inferred and stated:
Acceptance Criteria and Device Performance (Extended Sample Stability Claim)
1. A table of acceptance criteria and the reported device performance:
Since the submission is for an extended stability claim, the acceptance criteria would revolve around demonstrating that the device maintains its performance (identifying and enumerating specific cell populations) after 72 hours with EDTA-treated samples, compared to its established performance at 48 hours or earlier time points. The document states "Performance data from validation testing supports equivalency." This implies that the accepted performance for the enumeration of T lymphocytes (CD3+) and T-helper/inducer (CD3+CD4+) cells at 72 hours is equivalent to, or within acceptable limits of, the established performance at shorter stability times.
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred) | Reported Device Performance (Inferred) |
|---|---|---|
| Sample Stability | Maintain equivalent enumeration of CD3+ and CD3+CD4+ cells in EDTA whole blood at 72 hours compared to 48 hours or earlier time points. | "Performance data from validation testing supports equivalency." This suggests the device met the criteria. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified in the provided text.
- Retrospective or Prospective: Not specified in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not applicable in the context of this 510(k) summary. The device is a reagent for flow cytometry, and the "ground truth" for enumerated cell populations is typically established by the inherent physical properties and staining characteristics detected by the flow cytometer itself, rather than by expert consensus on images or pathology. The validation would involve assessing the reagent's ability to consistently and accurately identify markers over time.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This type of adjudication is typically used for image-based diagnostics where human interpretation is involved.
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:
Not applicable. This is a reagent, not an AI software assisting human readers.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
The device is a reagent to be used with flow cytometers and software (MultiSET™, CELLQuest™, CELLQuest Pro™ or LYSYS™ II software). The "standalone" performance here refers to the reagent's ability to consistently label cells correctly over time. The document implicitly confirms this standalone performance was evaluated to support the extended stability claim.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this type of device (flow cytometry reagent for cell enumeration) would be established by the inherent, reproducible measurement of cell populations by flow cytometry, typically validated against established methods or control materials. It's not based on expert consensus, pathology, or outcomes data in the traditional sense for diagnostic imaging or disease staging. The validation would verify that the reagent accurately binds to specific cell markers, leading to consistent enumeration results.
8. The sample size for the training set:
Not specified. For a reagent validation, there isn't a "training set" in the machine learning sense. The "training" essentially occurs during the reagent's development and optimization, with verification against known cell populations.
9. How the ground truth for the training set was established:
Not applicable in the machine learning sense. The ground truth for reagent development and validation would involve biochemical characterization of the reagent and its binding specificity, as well as testing against characterized cell lines or human blood samples with known cell population distributions using established flow cytometry protocols.
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K071/43
510(k) SUMMARY
1.0 Submitted By
BD Biosciences 2350 Qume Drive San Jose, CA 95131-1807
Contact:
Nobuko Nakajima Senior Requlatory Affairs Specialist Phone (408) 954-4109 Fax (408) 954-2495 Nobuko_Nakajima@bd.com
Submission date
April 20th, 2007
2.0 Device Name and Classification
a) BD™Tritest CD3/CD4/CD45
b) 864.5220 Automated differential cell counter, GKZ class II
3.0 Intended Use
The BD TriTEST™ CD3FITC/CD4PE/CD45 PerCP reagent is a three-color, direct immunofluorescence reagent for identifying and enumerating percentages of T lymphocytes (CD3+) and T-helper/inducer (CD3+CD4+) cells in erythrocyte-lysed whole blood (LWB).
4.0 Basic description of the device
The BD TriTEST™ CD3FITC/CD4PE/CD45 PerCP reagent is a three-color, direct immunofluorescence reagent for identifying and enumerating percentages of T lymphocytes (CD3+) and T-helper/inducer (CD3+CD4+) cells in erythrocyte-lysed whole blood (LWB). If used with Becton Dickinson flow cytometers, the product can be used with MultiSET™ software for analysis as an accessory, or customers may perform analysis using CELLQuest™ , CELLQuest Pro "" or LYSYS™ II software.
JUN -6 2007
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The reagent vials and counting bead vials are packaged separately. Each vial of this reagent yields 50 tests. Each package of counting bead tubes yields 50 tests.
5.0 Predicate Device
The BD™Tritest CD3/CD4/CD45 claims substantial equivalence to the BD™Tritest CD3/CD4/CD45 currently in distribution (FDA 510(k) number K946055/S2)
6.0 Comparison to the Predicate(s)
The modifications to the legally marketed device (BD™Tritest CD3/CD4/CD45) intends to extend the sample stability claim for EDTA from 48 to 72 hours
The Intended use and the indications of the modified device, as described in its labeling are the same as the intended use and indications for the original predicate device.
7.0 Summary of Performance Data
Performance data from validation testing supports equivalency.
This Summary of safety and effectiveness is being submitted in accordance with the requirements of compliance with SMDA 1990 and 21 CFR 807.92.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle emblem with three overlapping wing-like shapes.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN -6 2007
Nobuko Nakajima BD Biosciences 2350 Qume Drive San Jose, California 95131-1807
Re: K071143
Trade/Device Name: BD Tritest CD3/CD4/CD5 Regulation Number: 21 CFR 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: GKZ Dated: April 20, 2007 Received: April 24, 2007
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
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Page 2 – Nobuko Nakajima
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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, 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). 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/dsma/dsmamain.html.
Sincerely yours,
Robert Bootes
Robert L. Becker, Jr., MD, Ph 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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Attachment 1:
Indications for Use Statement
510(k) Number: K071143
Device Name: BD Tritest CD3/CD4/CD45
Indications For Use:
BD Tritest CD3 FITC/CD4 PE/CD45 PerCP is a three-color direct immunofluorescence reagent for identifying and enumerating percentage of mature human T lymphocytes (CD3+) and T-helper/inducer (CD3+CD4+) cells in erythrocyte-lysed whole blood (LWB).
Prescription Use X (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 Device Evaluation (OIVD)
Josephine Buttitta
Division Sign Off
Division Sign
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K071143
BD Biosciences Special 510(k): Device Modification Notification FDA correspondence K071143 and K071141
§ 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.”