(274 days)
The Chempaq XBC Analyzer is an in vitro diagnostic method intended for the quantitative determination of the concentration of white blood cells ("WBC"); granulocytes ("GRN"); lymphocytes ("LYM"); monocytes ("MON"); and total hemoglobin ("Hb") in whole-blood samples (finger stick or venous sample).
The Chempaq XBC Analyzer is indicated for use in: clinical laboratories, and for point-of-care hematology determinations in doctors' offices or by healthcare professionals in hospital settings to identify and classify one or more of the formed elements of blood.
The Chempaq XBC Analyzer consists of a single use cartridge, called the PAQ (Particle Analyzer and Quantifier), and a stationary Reader with a docking station, called a Cradle. The PAQ is connected to the Cradle by a simple push fit. The PAQ includes all required reagents and will, when connected to the Cradle, perform all sample manipulations required for the analysis. The sample manipulation is facilitated by electrical and pneumatic connections between the PAQ and the Cradle. The user is not required to add any reagent to the Reader.
The test procedure is very simple, as the user is only required to apply blood to the PAQ and place it into the Cradle. The rest of the test is carried out automatically within 3 minutes. No manipulation of reagents or other materials by the user is required.
The Chempaq XBC Analyzer is an in vitro diagnostic method for the quantitative determination of the concentration of various blood components. The provided text, however, focuses primarily on the general performance and special studies conducted to validate the device, rather than specifying explicit acceptance criteria with numerical targets. It states that "In all instances, the Chempaq XBC Analyzer functioned as intended," which implies that the device met internal, pre-defined acceptance criteria, but these criteria are not explicitly detailed.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance:
As mentioned, specific numerical acceptance criteria are not explicitly stated in the provided text. The text confirms that the device "functioned as intended" in all tests, implying all criteria were met.
| Performance Parameter | Acceptance Criteria (Not Explicitly Stated, Implied as "Functioned as Intended") | Reported Device Performance |
|---|---|---|
| Precision and accuracy | Acceptable levels for diagnostic use (implied) | Functioned as intended |
| Venous vs. capillary samples | No significant difference in results between sample types (implied) | Functioned as intended |
| Linearity | Demonstrates linearity across the reportable range (implied) | Functioned as intended |
| Interferences | Minimal clinically significant interference (implied) | Functioned as intended |
| Pre-analytical errors | Robust to common pre-analytical errors (implied) | Functioned as intended |
| Stability studies | Maintains performance over defined storage and operating conditions (implied) | Functioned as intended |
| Batch variability (in-batch and between-batch) | Consistent performance within and between manufacturing batches (implied) | Functioned as intended |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The text mentions "Testing was performed under two separate situations: 1) laboratory bench testing; and 2) point-of-use clinical testing, including point-of-care and physician office laboratory locations." However, the number of samples used in these tests is not provided.
- Data Provenance: The studies were conducted in "laboratory bench testing" and "point-of-use clinical testing, including point-of-care and physician office laboratory locations." The country of origin for the data is not specified, but the submitter, Chempaq A/S, is based in Copenhagen, Denmark, suggesting that some or all studies might have been conducted there or in clinics/labs associated with their operations. The studies appear to be prospective as they were conducted specifically for the validation of the Chempaq XBC Analyzer following approved test protocols.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The text does not detail how ground truth was established for the test set, nor does it mention the involvement or qualifications of experts for this purpose.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided in the document.
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:
This is not applicable to the Chempaq XBC Analyzer. This device is an automated differential cell counter, meaning it performs the analysis itself, rather than assisting human readers in interpreting images or data. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, a standalone performance study was done for the Chempaq XBC Analyzer. This is indicated by the "Performance Data" section which describes various tests directly evaluating the device's capabilities (precision, accuracy, linearity, stability, etc.) without human intervention in the analysis process. The device is described as operating "automatically within 3 minutes" after blood application.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The document does not explicitly state the specific type of ground truth used. For diagnostic devices measuring blood cell concentrations, ground truth would typically be established using reference methods or established laboratory techniques known for their accuracy and precision. For example, manual differential counts by trained technologists, or comparison with results from highly accurate predicate devices or gold standard instruments. The mention of "NCCLS" (National Committee for Clinical Laboratory Standards) and "ICSH" (International Council for Standardization in Haematology) documents as references suggests that recognized industry standards for establishing ground truth and evaluation were followed.
8. The sample size for the training set:
This information is not provided in the document. For a device like this, the "training set" might refer to data used during the development and optimization of the underlying algorithms, but the document does not specify this.
9. How the ground truth for the training set was established:
This information is not provided in the document. Similar to the test set, it would likely involve highly accurate reference methods, but the specifics are not detailed.
§ 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.”