(110 days)
No
The summary describes a hematology analyzer and reagents for counting specific cell types. There is no mention of AI, ML, or image processing, which are common indicators of AI/ML use in this context. The performance studies focus on traditional analytical metrics like accuracy, linearity, and precision.
No
The device is an in vitro diagnostic (IVD) system used to identify and enumerate lymphocyte percentages and counts, as well as provide CBC and WBC differentials. Its intended use is for diagnostic purposes, not for treating or preventing disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is "For In Vitro Diagnostic Use" and is intended to "identify and enumerate CD4+ and CD8+ T lymphocyte percentages and absolute counts in whole blood," which are diagnostic purposes. Additionally, it mentions providing "a complete blood count (CBC) and a white blood cell (WBC) differential," which are common diagnostic tests.
No
The device description explicitly states that the system consists of "reagents, sample processing accessories, instrument and software," indicating it is a complete system with hardware components, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The system is intended 'For In Vitro Diagnostic Use' to identify and enumerate CD4+ and CD8+ T lymphocyte percentages and absolute counts in whole blood..."
This statement clearly indicates that the device is intended for use in vitro (outside of the body) to diagnose or aid in the diagnosis of conditions by analyzing biological samples (whole blood).
N/A
Intended Use / Indications for Use
COULTER STKS Analyzer with CD4 and CD8 Lymphocyte Analysis is a complete system consisting of reagents, sample processing accessories, instrument and software. The system is intended "For In Vitro Diagnostic Use" to identify and enumerate CD4+ and CD8+ T lymphocyte percentages and absolute counts in whole blood using either of two versions of a quantitative, automated hematology analyzer and leukocyte differential counter: COULTER® STKS Analyzer or COULTER® STKS Analyzer with Reticulocyte Analysis. The system is also intended to provide the CD4/CD8 ratio, a complete blood count (CBC) and a white blood cell (WBC) differential. Reticulocyte percentage and absolute count are only available if using the COULTER® STKS Analyzer with Reticulocyte Analysis.
Product codes
GKZ
Device Description
COULTER® STKS Analyzer with CD4 and CD8 Lymphocyte Analysis
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)
Accuracy:
Study Type: Accuracy study
Sample Size: Not specified, but involved normal and abnormal (HIV, organ transplant, cancer, autoimmune disease) whole blood specimens from a geographically diverse population.
Key Results: Results analyzed demonstrated that STKS with CD4 and CD8 Analysis and CD3/CD4 and CD3/CD8 by Flow Cytometry identify and enumerate essentially identical numbers of lymphocytes in whole blood specimens.
Linearity:
Study Type: Linearity study
Sample Size: Five replicate measurements at each of five individually prepared dilutions of a concentrated normal venous whole blood specimen.
Key Results: Results analyzed demonstrated linearity of the assays.
Within Run (Intralaboratory) Precision:
Study Type: Precision study
Sample Size: Ten replicate measurements for each of CD4+ and CD8+ T lymphocyte concentrations.
Key Results: Results analyzed demonstrated within run (intralaboratory) precision of the assays.
Between Run (Run-to-Run) Precision:
Study Type: Precision study
Sample Size: Duplicate measurements for CD4+ and CD8+ T lymphocyte concentrations.
Key Results: Results analyzed demonstrated between run (run-to-run) precision of the assays.
Interlaboratory Precision:
Study Type: Precision study
Sample Size: Replicate measurements made on three different STKS instruments by three technicians for three levels of CD4+ and CD8+ T lymphocyte concentrations.
Key Results: Results analyzed demonstrated within run (intralaboratory) precision of the assays.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K922745, K922744, K885093, K932030
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
| JUL 22 1996 | |||||
|---|---|---|---|---|---|
| K961278 | Image: Coulter logo | ||||
| COULTER CORPORATION | |||||
| P.O. BOX 169015 | |||||
| Miami, Florida 33116-9015 USA | Date: | April 1, 1996 | |||
| Customer Service: (800) 526-7694 | |||||
| Product Information: (800) 526-6932 | |||||
| (305) 380-3800 | |||||
| (800) 327-6531 | Title: | Summary of Safety and Effectiveness Information For 510(k) Premarket | |||
| Notification | |||||
| Product: | COULTER® STKS Analyzer with CD4 and CD8 Lymphocyte Analysis | ||||
| Company: | Coulter Corporation | ||||
| 11800 SW 147 Avenue | |||||
| Miami, FL 33196-2500 | |||||
| Contact: | Dr. Marion S. Gaide (M/C: 31-B06) | ||||
| Senior Regulatory Affairs Specialist | |||||
| Corporate Regulatory Affairs | |||||
| Telephone: | 305-380-2594 | ||||
| Common or Usual or Classification Name: | Lymphocyte Immunophenotyping Using | ||||
| Monoclonal Antibody Reagents and Automated | |||||
| Differential Cell Counters | |||||
| Product Classification: | Product Code: GKZ; C.F.R. Section: 864.5220; Classification Panel: | ||||
| Hematology and Pathology Devices; Device Class: II | |||||
| Intended Use: | COULTER STKS Analyzer with CD4 and CD8 Lymphocyte Analysis is a | ||||
| complete system consisting of reagents, sample processing accessories, | |||||
| instrument and software. The system is intended "For In Vitro Diagnostic Use" | |||||
| to identify and enumerate CD4+ and CD8+ T lymphocyte percentages and | |||||
| absolute counts in whole blood using either of two versions of a quantitative, | |||||
| automated hematology analyzer and leukocyte differential counter: COULTER® | |||||
| STKS Analyzer or COULTER® STKS Analyzer with Reticulocyte Analysis. | |||||
| The system is also intended to provide the CD4/CD8 ratio, a complete blood | |||||
| count (CBC) and a white blood cell (WBC) differential. Reticulocyte percentage | |||||
| and absolute count are only available if using the COULTER® STKS Analyzer | |||||
| with Reticulocyte Analysis. | |||||
| Substantial Equivalence: | 510(k) Premarket Notification: K922745 | ||||
| CYTO-STAT®/COULTER CLONE® CD3(IgG1)-FITC/T4-RD1 | |||||
| Monoclonal Antibody Reagent (CD3/CD4) | |||||
| 510(k) Premarket Notification: K922744 | |||||
| CYTO-STAT®/COULTER CLONE® CD3(IgG1)-FITC/T8-RD1 | |||||
| Monoclonal Antibody Reagent (CD3/CD8) | |||||
| 510(k) Premarket Notification: K885093 | |||||
| COULTER® STKS Analyzer | |||||
| 510(k) Premarket Notification: K932030 | |||||
| COULTER® STKS Analyzer with Reticulocyte Analysis |
1
Product Differences: The subject hematologic method, STKS with CD4 and CD8 Analysis, and the comparator method, CD3/CD4 and CD3/CD8 by Flow Cytometry, necessarily differ in some respects as a result of the technologies used to achieve the same intended use. The primary differences are 1) instrumentation; 2) software versus reagent controls for lymphocyte gating and nontargeted monoclonal antibody binding to irrelevant cellular populations; 3) Mab conjugation; and 4) final product form of the reagents. With respect to instrumentation, it is noteworthy that the flow cytometric method requires both a flow cytometer and the same instrument used in the subject hematologic method.
Product Testing: Product testing to assess the performance of STKS with CD4 and CD8 Analysis is described below. Studies were designed in line with performance specifications and instructions for use provided in the product manuals and package inserts. Specimens were assayed with CD3/CD4 and CD3/CD8 by Flow Cytometry for comparison purposes. The results of product testing demonstrated that STKS with CD4 and CD8 Analysis met all performance specifications and provided CD4+ T lymphocyte values substantially equivalent to those obtained with the comparator method, CD3/CD4 and CD3/CD8 by Flow Cytometry.
1. Accuracy:
Normal and abnormal (i.e., HIV, organ transplant, cancer, autoimmune disease) whole blood specimens were collected from a geographically diverse population of males and females unselected as to race and ranging in age from 18 to 85 years. The specimens were divided and the samples processed and analyzed using either 1) COULTER™ CD4 or CD8 Cyto-Spheres™ Reagent on a STKS; or 2) CD3(1gG1)-FITC/T4-RD1 or CD3(1gG1)-FITC/T8-RD1 on an EPICS XL-MCL or EPICS Profile II flow ctyometer (gated on lymphocytes). A white blood cell count and 5-part differential were obtained for each whole blood specimen using the same STKS as in the subject hematologic method.
CD4+ and CD8+ T lymphocyte percentages and absolute counts obtained with CD4 and CD8 Cyto-Spheres Reagents on the STKS represented total CD4 and total CD8 values. Values obtained with CD3(lgG1)-FITC/T4-RD1 and CD3(IgG1)-FITC/T8-RD1 on the EPICS flow cytometers represented dual-positive, CD3+/CD4+ and CD3+/CD8+ values. Values were expressed in terms of percent of the total lymphocyte count and as absolute count (cells/uL). Flow cytometric values were corrected for lymphocyte purity (Lymphocyte Gate Limits: lymphocyte recovery ≥ 90%; lymphocyte purity ≥ 85%).
Results analyzed in terms of minimums, maximums, means ± 1 SD, regression and correlation analyses, and analyses of variance demonstrated that STKS with CD4 and CD8 Analysis and CD3/CD4 and CD3/CD8 by Flow Cytometry identify and enumerate essentially identical numbers of lymphocytes in whole blood specimens.
-
- Linearity:
Five replicate measurements were made at each of five individually prepared dilutions of a concentrated normal venous whole blood specimen to achieve a range of CD4+ or CD8+ T lymphocyte concentrations. Samples were processed with CD4 or CD8 Cyto-Spheres Reagent and analyzed on the STKS. Values were expressed in terms of absolute count (cells/uL).
- Linearity:
Results analyzed in terms of regression analyses and 95% confidence intervals of the data points for recovered versus expected absolute counts (cells/yL) demonstrated linearity of the assays.
- Within Run (Intralaboratory) Precision:
Ten replicate measurements were performed for each of CD4+ and CD8+ T lymphocyte concentrations on a STKS on the same day. A separate venous whole blood specimen was used for each CD4 or CD8 level and processed with CD4 or CD8 Cyto-Spheres Reagent prior to analysis. Values were expressed in terms of percent of the total lymphocyte count and as absolute count (cells/uL).
2
Results analyzed in terms of means ± 1 SD and CVs demonstrated within run (intralaboratory) precision of the assays.
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- Between Run (Run-to-Run) Precision:
Duplicate measurements were performed for CD4+ and CD8+ T lymphocyte concentrations on a STKS. A separate venous whole blood specimen was used to make both measurements. The specimen was divided and each half processed with CD4 or CD8 Cyto-Spheres Reagent prior to analysis. Values were expressed in terms of percent of the total lymphocyte count and as absolute count (cells/uL).
- Between Run (Run-to-Run) Precision:
Results analyzed in terms of minimums, maximums, means, and mean differences between runs ± 1 SD demonstrated between run (run-to-run) precision of the assays.
Interlaboratory Precision: ર.
Studies were performed for each of three levels of CD4+ and CD8+ T lymphocyte concentrations on the same day by three technicians using three different STKS instruments. Replicate measurements were made on each STKS. The same venous whole blood specimen was used to make all replicate measurements on all three instruments for a particular CD4 or CD8 percentage or absolute count level. The specimen was divided into thirds and each third processed with CD4 or CD8 Cyto-Spheres Reagent prior to analysis. Values were expressed in terms of percent of the total lymphocyte count and as absolute count (cells/uL).
Results analyzed in terms of means ± 1 SD and CVs demonstrated within run (intralaboratory) precision of the assays.
Marion S. Gracie
Marion S. Gaide, Ph.D. Senior Regulatory Affairs Specialist Corporate Regulatory Affairs
April 1, 1896
Date