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510(k) Data Aggregation
(36 days)
The ABX PENTRA DX 120 Hematology Analyzer is an automated hematology analyzer providing complete blood count (CBC), differential leucocyte count (DIFF) as well as reticulocyte count (RET), and nucleated red blood cell count (NRBC) for the in vitro diagnostic use in clinical laboratories.
The clinical use of the reticulocyte count, specifically the immature reticulocyte fraction (IRF), is to monitor erythropoietic activity in patients.
The option of the SPS Evolution (Slide Preparation System) smears and stains on a clean microscope slide.
The PENTRA DX 120 Automated Hematology Analyzer is a bench-top, clinical laboratory instrument which analyzes in-vitro samples of whole blood to provide complete blood count, leukocyte differential count, reticulocyte and NRBC count using principles of cytochemistry, focused flow impedance, light absorbance and fluorescence. The instrument is microprocessor driven.
Controlled by the PENTRA 120 the optional device SPS Evolution (Slide Preparation System) smears and stains the slides.
The provided text describes the ABX PENTRA DX 120 Hematology Analyzer and its associated SPS Evolution (Slide Preparation System). Here's a breakdown of the acceptance criteria and study information, based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance (NRBC Parameter)
The text focuses primarily on the Nucleated Red Blood Cell (NRBC) parameter as the new feature and provides limited, high-level performance statements rather than specific numerical acceptance criteria.
| Performance Metric | Acceptance Criteria (Implicit/General Statement) | Reported Device Performance |
|---|---|---|
| Precision (NRBC) | "good precision in accordance with EP5-A (NCCLS guidelines)" | "good precision ... and is entirely acceptable for the NRBC" |
| Linearity (NRBC/100 WBC Count) | "linearity limits claim... are entirely supported" | "entirely supported by the clinical data provided in this submission." |
| Accuracy (Inter-procedural Correlation - NRBC) | No specific numerical criteria stated, but implied to show no significant bias. | "showed no evidence of significant bias between the HoribaABX PENTRA DX 120 and the Abbott CD 4000, Sysmex XE-2100, and multiparameter flow cytometry with r^2 ranging between 0.96 - 0.98." |
| Differentiation (True/False Positives/Negatives - NRBC) | Implied to be comparable to predicate systems. | "provided good results on the differentiation between true & false positives and true & false negatives, comparable to other predicate systems." |
| Sample Stability (NRBC) | Implied to assure relative sample stability over 24 hours. | "assures a relative sample stability over a 24 hour period at both room temperature and 4°C." |
| Carry Over (NRBC) | Implied to be less than 1%. | "supporting a Carry Over claim of |
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(26 days)
The ABX MICROS 60 Hematology Analyzer is a fully automated (microprocessor controlled) hematology analyzer used for the in vitro diagnostic testing of whole blood specimens or blood cell concentrates. It operates in complete blood count (CBC) mode.
The ABX MICROS 60 device is a benchtop, clinical laboratory instruments that analyze in-vitro samples of whole blood specimens. The device operates in a complete blood count (CBC) and 3 part DIFF (LMG). As either a closed tube / closed system (CT/CS) or open tube/open system (OT/OS). The ABX MICROS 60 can evaluate 5,8, 16 or 18 hematology parameters depending on its internal configuration.
Here's a summary of the acceptance criteria and study information for the ABX MICROS 60 Hematology Analyzer based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily discusses that the device met acceptance criteria, but specific quantitative criteria for each parameter are not explicitly detailed in a separate table. Instead, general statements about meeting guidelines and correlations are provided.
| Performance Metric | Acceptance Criteria (Implied/Stated) | Reported Device Performance |
|---|---|---|
| Precision | In accordance with EPS-A (NCCLS guidelines) | "good precision... and is entirely acceptable for all parameters." No change to claimed limits. |
| Linearity | Supported by clinical data | WBC (0-100 x 10³/mm³), RBC (0-8.0 x 10⁹/mm³), HGB (0-26g/dl), HCT (0-80%), PLT with Hgb>2g/dl (0-2,200 x 10³/mm³), PLT with Hgb 0.95) |
| Safety and Effectiveness | Device is not compromised | "The clinical studies conclude that the safety and effectiveness of the devices is not compromised. Clinical testing met all acceptance criteria." "All clinical and non clinical tests show appropriate levels of safety and effectiveness." |
| Electrical Equipment Standard | Meets IEC 1010-1 | Device "meets with the IEC 1010-1 standard" |
| Electromagnetic Compatibility | Meets EN 61326 | Device "meets with... the EN 61326 standard" |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not explicitly stated. The document mentions "clinical data provided in this submission" and "clinical studies," but no specific sample size (number of patients or specimens) is given for the test set used to evaluate linearity and accuracy.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- Number and Qualifications of Experts: Not mentioned. For a hematology analyzer, ground truth typically refers to reference methods performed by trained laboratory personnel or comparison to a predicate device. The document states "Accuracy (Inter-procedural Correlation) demonstrated no evidence of significant bias between the MICROS 60 and the Abbott CD 4000," implying the Abbott CD 4000 served as the reference/ground truth for accuracy assessment.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable or not described. This type of adjudication is more common in studies involving subjective interpretation (e.g., medical imaging reads). For an automated hematology analyzer, performance is typically assessed by comparing its quantitative results against a reference method.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
- MRMC Study: No, an MRMC study was not done. This type of study would involve human readers interpreting cases with and without AI assistance, which is not relevant for an automated hematology analyzer like the ABX MICROS 60. The device performs automated analysis without human interpretation in the loop.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Yes, the entire performance evaluation described is for the device in standalone mode. The ABX MICROS 60 is an "automated cell counter and automated differential cell counter" and a "fully automated (microprocessor controlled) multi-parameter hematology analyzer." The performance data presented (precision, linearity, accuracy) are for the device operating independently.
7. The Type of Ground Truth Used:
- Ground Truth Type:
- For precision and linearity, the ground truth would typically be established by repeated measurements on stable samples and statistical analysis to ensure reproducibility and accurate measurement across concentration ranges.
- For accuracy (inter-procedural correlation), the ground truth was established by comparison to a legally marketed predicate device, the ABBOTT CD 4000 (K961439).
8. The Sample Size for the Training Set:
- Training Set Sample Size: Not applicable or not stated. Hematology analyzers like the ABX MICROS 60 typically rely on established physical principles (e.g., impedance, optical scattering) and calibrated reagents rather than machine learning algorithms trained on a dataset. Therefore, the concept of a "training set" in the context of AI/ML is not directly relevant here. The device is "based on the same fundamental technology" as predicate devices.
9. How the Ground Truth for the Training Set Was Established:
- Training Set Ground Truth Establishment: Not applicable, as there isn't a "training set" in the AI/ML sense. The device's operation is based on established scientific principles rather than being trained on a dataset.
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(16 days)
The ABX PENTRA 60 and 60C+ Hematology Analyzer are fully automated (microprocessor controlled) hematology analyzer used for the in vitro diagnostic testing of whole blood specimens.
The ABX PENTRA 60 and 60C+ Hematology Analyzer are able to operate either in complete blood count (CBC) mode or in CBC + 5 differential leucocyte count (5DIFF) mode.
The ABX PENTRA 60 & PENTRA 60C+ are benchtop, clinical laboratory instrument which analyzes in-vitro samples of whole blood to provide complete blood count and leucocyte differential count using principles of cytochemistry, focused flow impedance and light transmission using a halogen light source.
The PENTRA 60 is an standalone device using a keyboard and LCD screen integrated into the device. Whereas the PENTRA 60C+ is the PENTRA 60 connected to a dedicated workstation with user interfacing software.
The ABX PENTRA 60 and PENTRA 60C+ Hematology Analyzers underwent a study to demonstrate their performance against pre-defined acceptance criteria, primarily focusing on expanded linearity ranges and maintaining accuracy.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Precision | In accordance with EP5-A (NCCLS guidelines) | Good precision for all parameters, "entirely acceptable". |
| Linearity Range (WBC) | Not explicitly stated as a numerical range acceptance criterion, but the modification covers "extension of the linearity ranges for all parameters." | 0-120 x 10^3/μL |
| Linearity Range (RBC) | Not explicitly stated as a numerical range acceptance criterion, but the modification covers "extension of the linearity ranges for all parameters." | 0 - 8.0 x 10^5/μL |
| Linearity Range (HGB) | Not explicitly stated as a numerical range acceptance criterion, but the modification covers "extension of the linearity ranges for all parameters." | 0 - 24g/dl |
| Linearity Range (HCT) | Not explicitly stated as a numerical range acceptance criterion, but the modification covers "extension of the linearity ranges for all parameters." | 0 - 67% |
| Linearity Range (PLT with Hgb>2g/dl) | Not explicitly stated as a numerical range acceptance criterion, but the modification covers "extension of the linearity ranges for all parameters." | 0 - 1,900 x 10^3/μL |
| **Linearity Range (PLT with Hgb 0.95 | ||
| Accuracy (Inter-procedural Correlation for other parameters) | Not explicitly stated, but implies historical good correlation from previous submissions. | Good correlation demonstrated in previous submissions. |
| Carry-over |
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(30 days)
The ABX PENTRA 80 Hematology Analyzer is a fully automated (microprocessor controlled) hematology analyzer used for the in vitro diagnostic testing of whole blood specimens.
The ABX PENTRA 80 is able to operate either in complete blood count (CBC) mode or in CBC + 5 differential leucocyte count (5DIFF) mode.
The PENTRA 80 Hematology analyzer is a benchtop, clinical laboratory instrument which analyzes in-vitro samples of whole blood to provide complete blood count and leucocyte differential count using principles of cytochemistry, focused flow impedance and light transmission using a halogen light source. The instrument is microprocessor driven, with an internal PC that performs further data processing and hosts the user interface.
The provided text describes the ABX PENTRA 80 Hematology Analyzer and its performance in a 510(k) premarket notification. However, it does not contain a detailed table of acceptance criteria or performance metrics with specific numerical values for a direct comparison. The information is presented in a narrative format, highlighting that the device met certain standards and showed good correlation with a predicate device.
Here's an attempt to extract the requested information based on the available text:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Precision | Acceptable for all parameters (in accordance with EP5-A NCCLS guidelines) | "good precision... and is entirely acceptable for all available parameters." (No specific numerical values provided in the summary, only a general statement of compliance with guidelines.) |
| Linearity | Supported by clinical data | WBC (0-120 x 10^3/μL), RBC (0 - 8.0 x 10^6/uL), HGB (0 - 24g/dl), HCT (0 - 67%), PLT with Hgb>2g/1 (0 - 1,900 x 10^3/μL), and PLT with Hgb 0.95 with predicate device) |
| Leukocyte Differentiation | Good results on differentiation between true & false positives and true & false negatives | "provided good results on the differentiation between true & false positives and true & false negatives." (No specific sensitivity, specificity, or accuracy metrics provided.) |
| Sample Stability | Relative sample stability over a 48-hour period at 4°C | "assures a relative sample stability over a 48 hour period at 4°C." |
| Carry Over |
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