(55 days)
The COULTER® AC T diff 2m analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories.
An automated differential cell counter is a device used to identify and classify one or more of the formed elements of blood.
The COULTER® Ac·T diff 2™ Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. COULTER® Ac.T diff 2™ Analyzer has the same technological characteristics and is substantially equivalent to the COULTER® COUNTER® S-PLUS IV and LYSE S PLUS D (also called COULTER COUNTER® Model S PLUS IV with Three Population Differential and Model S PLUS IV Diff), which was cleared by 510(k) K823355 on Dec. 28, 1982 and is a modified version of the COULTER® Ac-T diff ™ Analyzer which were cleared by 510(k) K973634 on October 29, 1997.
As with the predicate devices, the COULTER® Ac-T diff 2™ Analyzer utilizes the Coulter principle for the enumeration and sizing of blood cells, in combination with an automatic diluting and mixing device for sample processing and a single beam photometer for the measurement of hemoglobin. The same reagent system, composed of an isotonic diluent, lyitc reagent to lyse red blood cells for WBC and hemoglobin measurement and instrument cleaner, is used on Model S PLUS IV Diff and Ac-T diff Analyzers.
All the devices determine the following CBC parameters: WBC, LY #, LY%, MO #, MO %, GR #, GR %, RBC, Hgb, Hct, MCV, MCH, MCHC, Plt, RDW, MPV. Pct* and PDW* are also measured. *These parameters are not for diagnostic use but can be used as internal instrument checks on the platelet parameters.
Like the Ac T diff Analyzer, the Ac T diff 2 can analyze samples in either of two modes: whole blood and pre-dilute. Additionally, the Ac-T diff 2 can sample closed vial specimens by virtue of a rotary cap piercing functionality. The MODEL S PLUS IV Diff does not have a pre-dilute mode or a closed vial sampling mode.
This document is primarily a 510(k) submission, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the same way a de novo or PMA submission might.
Therefore, the requested information, particularly regarding acceptance criteria, a study proving the device meets the criteria, sample sizes for test sets and training sets, expert qualifications, and ground truth adjudication, is not explicitly provided in the given text.
The document describes the device, its intended use, and compares its technological characteristics to predicate devices. It states that the device "has the same technological characteristics" and is "substantially equivalent" to the predicate. This implies that the performance characteristics are expected to be similar, but it doesn't detail a specific acceptance criteria study for this new device.
However, based on the information provided, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" for the COULTER® Ac·T diff 2™ Analyzer. Instead, it outlines the parameters measured by the device and asserts its substantial equivalence to predicate devices, implying that its performance is comparable to those already cleared devices.
| Parameter Measured (Implicit Performance Standard: Substantial Equivalence to Predicate Devices) | Reported Device Performance (Implied by Substantial Equivalence) |
|---|---|
| WBC (Leukocyte count) | Performance comparable to COULTER® Ac-T diff™ Analyzer (K973634) and COULTER® COUNTER® S-PLUS IV and LYSE S PLUS D (K823335) |
| LY # (Lymphocyte number) | As above |
| LY% (Lymphocyte percent) | As above |
| MO # (Mononuclear number) | As above |
| MO % (Mononuclear percent) | As above |
| GR # (Granulocyte number) | As above |
| GR % (Granulocyte percent) | As above |
| RBC (Erythrocyte count) | As above |
| Hgb (Hemoglobin) | As above |
| Hct (Hematocrit) | As above |
| MCV (Mean Corpuscular Volume) | As above |
| MCH (Mean Corpuscular Hemoglobin) | As above |
| MCHC (Mean Corpuscular Hemoglobin Concentration) | As above |
| Plt (Platelet or thrombocyte count) | As above |
| RDW (Red Cell Distribution Width) | As above |
| MPV (Mean Platelet (thrombocyte) Volume) | As above |
| Pct* (Plateletcrit) | As above (*Note: Not for diagnostic use) |
| PDW* (Platelet Distribution Width) | As above (*Note: Not for diagnostic use) |
| Three-population leukocyte count (LY %, MO%, GR %) from WBC histogram based on cell size | As above |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide details about a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective) for the Ac-T diff 2 device. The submission relies on demonstrating substantial equivalence to predicate devices, rather than presenting a de novo performance study with a new dataset.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not provided in the document. As a 510(k) submission, the focus is on technological similarity to existing devices, not on a new clinical study requiring independent expert ground truth establishment for novel algorithms.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study is mentioned or implied. The device is an automated hematology analyzer, not a diagnostic imaging AI system that typically involves human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The device itself is a standalone automated hematology analyzer. Its performance is inherent to its operation as described, without human intervention in the analysis process (though human interpretation of results is part of clinical use). However, the document does not present a specific standalone study for the Ac-T diff 2 device; it focuses on its substantial equivalence to prior predicate devices.
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for any specific performance study of the Ac-T diff 2. Given it's a hematology analyzer, "ground truth" for its parameters (e.g., cell counts, hemoglobin) would typically be established through reference methods, manual microscopy, or highly characterized control materials, which are standard for predicate devices of this type. The Ac-T diff 2 is presented as technically equivalent to these established devices.
8. Sample Size for the Training Set
No training set or associated sample size is mentioned. This device is a traditional automated analyzer based on physical principles (Coulter principle, photometry), not a machine learning or AI algorithm that typically has a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set for a machine learning model is mentioned.
§ 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.”