The Cell-Dyn 3500 is a table-top analyzer consisting of the main analyzer, data station, and printer. An optional Sample Loader can be attached to the analyzer to transport samples in racks for automated processing.

The instrument has two sampling modes: Open Sample Aspiration Mode and Closed Sample Aspiration Mode. The instrument has the capability of diluting a sample for a CBC including a 5-part WBC differential for a total of 20 parameters. The 20 reportable parameters are as follows:

White blood cells (WBC), red blood cells (RBC), platelets (PLT), percent of neutrophils (%N), number of neutrophils (NEU), percent of lymphocytes (%L), number of lymphocytes (LYM), percent of monocytes (%M), number of monocytes (MONO), percent of eosinophils (%E), number of eosinophils( EOS), percent of basophils (%B), number of basophils(BASO), hemoglobin (HGB), hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), red cell distribution width (RDW) and mean platelet volume (MPV).

AI/ML Overview

The provided text describes the Cell-Dyn® 3500 System, a multi-parameter automated hematology analyzer, and presents data supporting its substantial equivalence to previously marketed devices. However, it does not contain detailed acceptance criteria or a study proving that the device meets those criteria in the format requested. The document focuses on demonstrating substantial equivalence rather than explicit performance acceptance criteria with detailed study results against them.

Therefore, many of the requested fields cannot be directly extracted from the provided text. I will fill in what information is available and note when information is missing.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance:

The document states: "The accuracy, precision and linearity data shows performance to manufacturer's specifications. The data supports our claim that the Cell-Dyn 3500 is substantially equivalent to the Coulter S+IV." However, the manufacturer's specifications (i.e., the acceptance criteria) and the specific reported device performance data for these parameters are not provided in the text.

Acceptance Criteria (Not explicitly stated in text)	Reported Device Performance (Not explicitly stated in text)
Accuracy: [Specific threshold/range]	Data "shows performance to manufacturer's specifications"
Precision: [Specific threshold/range]	Data "shows performance to manufacturer's specifications"
Linearity: [Specific threshold/range]	Data "shows performance to manufacturer's specifications"
Carryover: [Specific threshold/range]	Data supports claim of substantial equivalence
WBC Differential Accuracy: [Specific threshold/range vs. manual method]	"Cell-Dyn 3500 WBC differential has been compared to the NCCLS reference microscopic manual differential method for accuracy." (Specific results not given)

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 for test set: Not specified. The document mentions "The data compiled to support the claim...".
Data provenance: Not specified. (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

For the WBC differential accuracy, it states: "The Cell-Dyn 3500 WBC differential has been compared to the NCCLS reference microscopic manual differential method for accuracy." This implies that trained personnel performed the manual differential counts for comparison, which would serve as a form of ground truth.
Number of experts: Not specified.
Qualifications of experts: Not specified. (However, performing NCCLS reference microscopic manual differential implies trained laboratory technicians or pathologists).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not specified.

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:

No, this is not an MRMC study related to AI assistance. The device is an automated hematology analyzer, not an AI-assisted diagnostic tool as typically understood in the context of MRMC studies for image analysis etc. The comparison is between the automated analyzer's results and established manual/other automated methods.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Yes, this is effectively a standalone performance study. The document describes the "Cell-Dyn 3500" analyzer's performance (accuracy, precision, linearity, carryover) and its comparison to other instruments and a manual method. This assesses the device's inherent performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For WBC differential accuracy: The "NCCLS reference microscopic manual differential method" was used as a ground truth comparison.
For other parameters (accuracy, precision, linearity, carryover): The implied ground truth would be accepted laboratory reference methods or established standards against which the device's measurements are validated.

8. The sample size for the training set:

Not applicable / not specified. This device is from 1996 and uses electrical impedance and laser optical methods, not machine learning or AI models in the modern sense that require a "training set" to learn from data. Its principles are based on physical measurements and established algorithms.

9. How the ground truth for the training set was established:

Not applicable. (See point 8).

Summary

{0}------------------------------------------------

OCT = 8 1996

Cell-Dyn® 3500 System

Image /page/0/Picture/2 description: The image shows a sequence of characters, seemingly handwritten. The characters are 'K 455 /13'. The characters are written in a bold, dark font, and they appear to be part of a larger document or label.

510(k) Summary

510(k) SUMMARY

CELL-DYN®3500 Multi-Parameter Automated Hematology Analyzer

SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING A SUBSTANTIALLY EQUIVALENT DETERMINATION

The following information as presented in the Premarket Notification (510(k) for the Cell-Dyn® 3500 Hematology Analyzer constitutes data supporting a substantially equivalent determination.

Substantial equivalence has been demonstrated between the Cell-Dyn 3500 and the Coulter® ZBI (marketed prior to May 1976), Coulter Hemoglobinometer (marketed prior to May 1976), the Coulter Model S (marketed prior to May 1976), and the Coulter Model S Plus IV, Premarket Notification #K823355.

Intended Use

The Cell-Dyn 3500 is a multi-parameter, hematology analyzer designed for In-Vitro diagnostic use in clinical laboratories.

Device Description

Principles of Operation

The Shear valve isolates a precise volume of whole blood by means of a shearing action as the front and rear sections rotate. The aspirated blood is isolated in three separate segments - one for the WOC dilution, one for the WIC/HGB dilution and one for the RBC/PLT dilution. The WOC segment is diluted with the sheath reagent. The WIC/HGB segment is diluted with the diluent and WIC/HGB lyse reagent is added to lyse the RBCs. The RBC/PLT segment is diluted with the diluent.

{1}------------------------------------------------

The instrument then measures, using the electrical impedance method, the number and size of cells present per volume of whole blood for RBC and PLT. It measures, using laser optical methods, the number of WBCs (WOC or WBC Optical count) present per volume of whole blood, and using electrical impedance (WIC or WBC Impedance count). It derives, using light scattering measurements, values for: %N. %L. %M. %E and %B. It derives, using electrical impedance measurements, values for: MCV, RDW, MPV, PDW, and, calculates, using appropriate measured or derived data, the values for: NEU, LYM, MONO, EOS, BASO, HCT, MCH, MCHC and PCT.

Similarities and Differences

The methods of determination are those used by the Coulter, Hemoglobinometer, Coulter Model S, Coulter Model S Plus Series, Coulter STKS and the manual microscopic differential count. These methods collectively perform one or more of the determinations which are combined in the Cell-Dyn® 3500.

The Cell-Dyn 3500 differs from the above instruments in that it combines optical (WOC) and impedance (WIC) methods in order to provide a more accurate WBC count in the presence of certain interfering substances (such as lyse-resistant RBCs). Additionally, the Cell-Dyn 3500 monitors the optical WBC count to detect and flag the presence of fragile WBCs and mathematically correct the count for their presence.

In addition, as a response to the demand for environmentally safe cyanide-free products, the HGB/WIC lysing reagent has been modified to remove the cyanide compound. A new methemoglobin method has been developed using hydroxyalamine as the direct oxidant replacing cyanide. This new cyanide-free method produces HGB results that correlate well with cyanide-containing methods.

Finally, the shear valve has been modified with the addition of a loop aspiration system to enhance reliability and require less maintenance.

Equivalency Data

The data compiled to support the claim that the CELL-DYN 3500 is substantially equivalent to the Coulter Model S Plus IV includes accuracy, precision, linearity and carryover. The Cell-Dyn 3500 WBC differential has been compared to the NCCLS reference microscopic manual differential method for accuracy.

The accuracy, precision and linearity data shows performance to manufacturer's specifications. The data supports our claim that the Cell-Dyn 3500 is substantially equivalent to the Coulter S+IV. The modifications of the instrument are intended to enhance the safety and effectiveness of the Cell-Dyn 3500 and demonstrate substantial equivalence to the Coulter S Plus IV and Cell-Dyn 3500, #K913305/A.

{2}------------------------------------------------

고

Conclusion

In conclusion, the Cell-Dyn 3500 update shows an evolution of the technology used that is similar to the technology used in the Coulter S Plus IV, Coulter Hemoglobinometer, and the Coulter Model S series.

This 510(k) Summary was prepared and submitted March 26, 1996 by:

Janice E. Brown Regulatory Affairs Manager Abbott Diagnostics 5440 Patrick Henry Drive Santa Clara, CA 95054 Phone: 408-567-3521 Fax: 408-982-4863

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.”