(325 days)
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Here's a breakdown of the acceptance criteria and study details based on the provided text:
Acceptance Criteria and Device Performance
The acceptance criteria for the Technicon H+3 RTC/RTX reticulocyte method are implied by the reported performance characteristics and the stated goals of the evaluation. While explicit threshold values are not given, the device is considered to meet acceptance criteria if its performance is comparable to established methods (NCCLS for reticulocytes) and demonstrates high correlation and low bias for RBC indices.
Table of Acceptance Criteria (Implied) and Reported Device Performance
| Parameter | Implied Acceptance Criteria (e.g., strong correlation, low bias) | Reported Device Performance | Study Type |
|---|---|---|---|
| Reticulocyte Count | Accuracy (vs. Manual Counts) | ||
| % retic (r) | High correlation (e.g., >0.90) | 0.97 | Comparison to NCCLS method |
| % retic (Slope) | Close to 1 (e.g., 0.9-1.1) | 0.93 | Comparison to NCCLS method |
| % retic (Intercept) | Close to 0 | 0.0 | Comparison to NCCLS method |
| % retic (Syx) | Low error | 0.56 | Comparison to NCCLS method |
| % retic (Reference Mean) | Matches H•3 Mean closely | 2.0 | Comparison to NCCLS method |
| % retic (H•3 Mean) | Matches Reference Mean closely | 1.9 | Comparison to NCCLS method |
| abs retic (10^9^/L) (r) | High correlation (e.g., >0.90) | 0.93 | Comparison to NCCLS method |
| abs retic (Slope) | Close to 1 (e.g., 0.9-1.1) | 0.86 | Comparison to NCCLS method |
| abs retic (Intercept) | Close to 0 | 6.4 | Comparison to NCCLS method |
| abs retic (Syx) | Low error | 22.6 | Comparison to NCCLS method |
| abs retic (Reference Mean) | Matches H•3 Mean closely | 84.9 | Comparison to NCCLS method |
| abs retic (H•3 Mean) | Matches Reference Mean closely | 79.1 | Comparison to NCCLS method |
| RBC Indices | Accuracy (vs. H+3 CBC/Diff Mode) | ||
| MCV (r) | High correlation (e.g., >0.95) | 0.974 | Comparison to H+3 CBC/Diff |
| MCV (Slope) | Close to 1 (e.g., 0.9-1.1) | 0.88 | Comparison to H+3 CBC/Diff |
| MCV (Intercept) | Close to 0 | 10.0 | Comparison to H+3 CBC/Diff |
| MCV (Syx) | Low error | 1.0 | Comparison to H+3 CBC/Diff |
| MCV (Bias) | Close to 0 | -0.1 | Comparison to H+3 CBC/Diff |
| CHCM (r) | High correlation (e.g., >0.95) | 0.988 | Comparison to H+3 CBC/Diff |
| CHCM (Slope) | Close to 1 (e.g., 0.9-1.1) | 1.06 | Comparison to H+3 CBC/Diff |
| CHCM (Intercept) | Close to 0 | -1.6 | Comparison to H+3 CBC/Diff |
| CHCM (Syx) | Low error | 0.7 | Comparison to H+3 CBC/Diff |
| CHCM (Bias) | Close to 0 | 0.4 | Comparison to H+3 CBC/Diff |
| CH (r) | High correlation (e.g., >0.95) | 0.980 | Comparison to H+3 CBC/Diff |
| CH (Slope) | Close to 1 (e.g., 0.9-1.1) | 0.95 | Comparison to H+3 CBC/Diff |
| CH (Intercept) | Close to 0 | 2.0 | Comparison to H+3 CBC/Diff |
| CH (Syx) | Low error | 0.6 | Comparison to H+3 CBC/Diff |
| CH (Bias) | Close to 0 | 0.5 | Comparison to H+3 CBC/Diff |
| RDW (r) | High correlation (e.g., >0.90) | 0.937 | Comparison to H+3 CBC/Diff |
| RDW (Slope) | Close to 1 (e.g., 0.9-1.1) | 1.06 | Comparison to H+3 CBC/Diff |
| RDW (Intercept) | Close to 0 | -0.8 | Comparison to H+3 CBC/Diff |
| RDW (Syx) | Low error | 0.5 | Comparison to H+3 CBC/Diff |
| RDW (Bias) | Close to 0 | 0.1 | Comparison to H+3 CBC/Diff |
| HDW (r) | High correlation (e.g., >0.95) | 0.990 | Comparison to H+3 CBC/Diff |
| HDW (Slope) | Close to 1 (e.9., 0.9-1.1) | 1.13 | Comparison to H+3 CBC/Diff |
| HDW (Intercept) | Close to 0 | -0.25 | Comparison to H+3 CBC/Diff |
| HDW (Syx) | Low error | 0.14 | Comparison to H+3 CBC/Diff |
| HDW (Bias) | Close to 0 | 0.11 | Comparison to H+3 CBC/Diff |
| Precision | Low SD and CV | Within Run Precision | |
| Retic (%) (CV) | Low CV (e.g., |
§ 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.”