(325 days)
K/DEN: 021434, SE020087
Technicon H+3, Technicon H+2
No
The summary describes a traditional laboratory analyzer and its performance evaluation using standard statistical methods, with no mention of AI or ML.
No.
The device is used to evaluate the accuracy of a reticulocyte method and RBC indices, which are diagnostic tests, not therapeutic interventions.
Yes
The "Summary of Performance Studies" section describes the evaluation of the Technicon H+3 RTC/RTX reticulocyte method, which involves counting reticulocytes and evaluating RBC indices. These measurements are used in diagnosing various blood conditions.
No
The summary describes performance studies related to a "Technicon H+3 RTC/RTX reticulocyte method" and compares it to a "Technicon H+2 system". This strongly suggests the device involves hardware (likely a hematology analyzer) for sample processing and analysis, not just software.
Based on the provided text, the device is likely an IVD (In Vitro Diagnostic). Here's why:
- Performance Studies: The text describes performance studies evaluating the "Technicon H+3 RTC/RTX reticulocyte method." These studies involve analyzing human blood samples ("apparently healthy donors" and "hospital patients") to measure reticulocyte counts and RBC indices. This type of testing on biological samples to provide information for medical purposes is characteristic of IVDs.
- Comparison to a Standard: The accuracy study compares the device's method to the "NCCLS proposed standard for reticulocyte counting using new methylene blue." This indicates the device is intended to perform a diagnostic test that has established standards.
- Mention of "Method": The repeated use of "method" in the context of analyzing blood components (reticulocytes, RBC indices) further suggests a diagnostic test.
- Reference Device: The mention of a "Technicon H+2 system" as a reference device for obtaining RBC counts implies the H+3 is also involved in blood analysis.
While the "Intended Use / Indications for Use" section is "Not Found," the detailed description of the performance studies strongly points towards the device being used for in vitro diagnostic testing of blood samples.
N/A
Intended Use / Indications for Use
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Product codes
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Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Accuracy of the Technicon H+3 RTC/RTX reticulocyte method was evaluated by comparison to the NCCLS proposed standard for reticulocyte counting using new methylene blue. Fifty samples were obtained from apparently healthy donors and forty-eight samples were obtained from hospital patients including patients with known red cell abnormalities. Each sample was counted independently by two technologists using the NCCLS method and was assayed in duplicate on a Technicon H43 for a total sample size of n=196. Reference absolute counts were obtained from the technologist % reticulocyte result and an RBC count from a Technicon H+2 system.
Accuracy of the Technicon H•3 RTC/RTX reticulocyte method RBC indices was evaluated by comparison to the RBC indices obtained from the H+3 RBC/platelet and hemoglobin methods (CBC/Diff mode) in the experiment described above (n=196). Accuracy of MCV, CHCM, RDW, and HDW was evaluated by comparison to the identical parameter obtained from the RBC/platelet method. The accuracy of CH was evaluated by comparison to MCH which is calculated from the RBC count and hemoglobin measurement.
Within run precision of the reticulocyte method was tested by 25 replicate assays performed for each of 5 samples obtained from apparently healthy donors.
The linearity of the % reticulocyte count was tested by making serial dilutions of a human pool prepared to obtain a high reticulocyte count. The results from this study indicate that the response is linear from 0% to 26% reticulocytes.
Carryover of the reticulocyte method was measured using high level human pools. No detectable carryover was observed for reticulocyte counts.
Prepared sample stability over the claimed range of 15 to 90 minutes was tested by assaying 15 prepared samples obtained from apparently healthy donors from 15 to 90 minutes at 15 minute intervals. The test results indicate that all samples were within ±0.5% of the % reticulocyte recovery obtained at 30 minutes.
Key Metrics
Reticulocyte Count:
% retic: r = 0.97, Slope = 0.93, Intercept = 0.0, Syx = 0.56, Reference Mean = 2.0, H•3 Mean = 1.9, Range of Samples = 0.2 to 26.2
abs retic (10 9/L): r = 0.93, Slope = 0.86, Intercept = 6.4, Syx = 22.6, Reference Mean = 84.9, H•3 Mean = 79.1, Range of Samples = 7.4 to 552.8
RBC Indices:
MCV: r = 0.974, Slope = 0.88, Intercept = 10.0, Syx = 1.0, Mean in CBC/Diff Mode = 84.8, Mean in Reticulocyte Mode = 84.7, Bias = -0.1
CHCM: r = 0.988, Slope = 1.06, Intercept = -1.6, Syx = 0.7, Mean in CBC/Diff Mode = 33.1, Mean in Reticulocyte Mode = 33.5, Bias = 0.4
CH: r = 0.980, Slope = 0.95, Intercept = 2.0, Syx = 0.6, Mean in CBC/Diff Mode = 27.5, Mean in Reticulocyte Mode = 28.0, Bias = 0.5
RDW: r = 0.937, Slope = 1.06, Intercept = -0.8, Syx = 0.5, Mean in CBC/Diff Mode = 15.7, Mean in Reticulocyte Mode = 15.8, Bias = 0.1
HDW: r = 0.990, Slope = 1.13, Intercept = -0.25, Syx = 0.14, Mean in CBC/Diff Mode = 2.79, Mean in Reticulocyte Mode = 2.90, Bias = 0.11
Within Run Precision:
Retic (%): Mean = 1.1, SD = 0.14, CV (%) = 12.7
Abs Retic (109 cells/L): Mean = 52.2, SD = 6.3, CV (%) = 12.1
MCV (fL): Mean = 90.5, SD = 0.44, CV (%) = 0.5
MCVr (fL): Mean = 110.8, SD = 2.1, CV (%) = 1.9
CHCM (g/dL): Mean = 32.3, SD = 0.20, CV (%) = 0.6
CHCMr (g/dL): Mean = 27.7, SD = 0.5, CV (%) = 1.5
CH (pg): Mean = 28.6, SD = 0.08, CV (%) = 0.3
CHr (pg): Mean = 29.9, SD = 0.5, CV (%) = 1.3
RDW (%): Mean = 13.2, SD = 0.09, CV (%) = 0.7
RDWr (%): Mean = 14.8, SD = 1.2, CV (%) = 8.1
HDW (g/dL): Mean = 2.59, SD = 0.05, CV (%) = 1.9
HDWr (g/dL): Mean = 3.04, SD = 0.22, CV (%) = 7.2
HHDW (pg): Mean = 3.40, SD = 0.02, CV (%) = 0.6
HHDWr (pg): Mean = 3.84, SD = 0.28, CV (%) = 7.3
Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.”
0
AUG 23 1996 SUMMARY OF SAFETY AND EFFEC
METHOD PERFORMANCE CHARACTERISTICS
The following is a summary of performance characteristics obtained from evaluations of the Technicon H+3 RTC/RTX reticulocyte method. The values shown in this section are point estimates of performance which can be expected from the method. Similar evaluations may produce slightly different results depending on the characteristics of the donor population.
ACCURACY
Reticulocyte Count
Accuracy of the Technicon H+3 RTC/RTX reticulocyte method was evaluated by comparison to the NCCLS proposed standard for reticulocyte counting using new methylene blue. Fifty samples were obtained from apparently healthy donors and forty-eight samples were obtained from hospital patients including patients with known red cell abnormalities. Each sample was counted independently by two technologists using the NCCLS method and was assayed in duplicate on a Technicon H43 for a total sample size of n=196. Reference absolute counts were obtained from the technologist % reticulocyte result and an RBC count from a Technicon H+2 system. The test results appear in the table below.
| Parameter | r | Slope | Intercept | Syx | Reference
Mean | H•3
Mean | Range of Samples |
|--------------------|------|-------|-----------|------|-------------------|-------------|------------------|
| % retic | 0.97 | 0.93 | 0.0 | 0.56 | 2.0 | 1.9 | 0.2 to 26.2 |
| abs retic (10 9/L) | 0.93 | 0.86 | 6.4 | 22.6 | 84.9 | 79.1 | 7.4 to 552.8 |
Table 4-4 ACCURACY VERSUS MANUAL COUNTS
Due to the substantial error associated with the manual counting technique , laboratories performing similar accuracy evaluations may obtain incorrect least squares regression coefficients when the range of samples is small'. In this event, the coefficients can be corrected by averaging manual results from 4 or more technologists, or by calculating the regression coefficients using a method derived by Deming .
RBC Indices
Accuracy of the Technicon H•3 RTC/RTX reticulocyte method RBC indices was evaluated by comparison to the RBC indices obtained from the H+3 RBC/platelet and hemoglobin methods (CBC/Diff mode) in the experiment described above (n=196). Accuracy of MCV, CHCM, RDW, and HDW was evaluated by comparison to the identical parameter obtained from the RBC/platelet method. The accuracy of CH was evaluated by comparison to MCH which is calculated from the RBC count and hemoglobin measurement.
| Parameter | r | Slope | Intercept | Syx | Mean in
CBC/Diff
Mode | Mean in
Reticulocyte
Mode | Bias |
|-----------|-------|-------|-----------|------|-----------------------------|---------------------------------|------|
| MCV | 0.974 | 0.88 | 10.0 | 1.0 | 84.8 | 84.7 | -0.1 |
| CHCM | 0.988 | 1.06 | -1.6 | 0.7 | 33.1 | 33.5 | 0.4 |
| CH | 0.980 | 0.95 | 2.0 | 0.6 | 27.5 | 28.0 | 0.5 |
| RDW | 0.937 | 1.06 | -0.8 | 0.5 | 15.7 | 15.8 | 0.1 |
| HDW | 0.990 | 1.13 | -0.25 | 0.14 | 2.79 | 2.90 | 0.11 |
Table 4-5 ACCURACY OF RBC INDICES
1
SUMMARY OF SAFETY AND EFFECTIVENESS
WITHIN RUN PRECISION CHARACTERISTICS
Within run precision of the reticulocyte method was tested by 25 replicate assays performed for each of 5 samples obtained from apparently healthy donors. The average result, which represents typical performance, appears in the table below.
| Parameter | Mean | SD | CV (%) |
|---|---|---|---|
| Retic (%) | 1.1 | 0.14 | 12.7 |
| Abs Retic (109 cells/L) | 52.2 | 6.3 | 12.1 |
| MCV (fL) | 90.5 | 0.44 | 0.5 |
| MCVr (fL) | 110.8 | 2.1 | 1.9 |
| CHCM (g/dL) | 32.3 | 0.20 | 0.6 |
| CHCMr (g/dL) | 27.7 | 0.5 | 1.5 |
| CH (pg) | 28.6 | 0.08 | 0.3 |
| CHr (pg) | 29.9 | 0.5 | 1.3 |
| RDW (%) | 13.2 | 0.09 | 0.7 |
| RDWr (%) | 14.8 | 1.2 | 8.1 |
| HDW (g/dL) | 2.59 | 0.05 | 1.9 |
| HDWr (g/dL) | 3.04 | 0.22 | 7.2 |
| HHDW (pg) | 3.40 | 0.02 | 0.6 |
| HHDWr (pg) | 3.84 | 0.28 | 7.3 |
Table 4-6 BEPLICATE PRECISION
LINEARITY
The linearity of the % reticulocyte count was tested by making serial dilutions of a human pool prepared to obtain a high reticulocyte count. The results from this study indicate that the response is linear from 0% to 26% reticulocytes.
CARRYOVER
Carryover of the reticulocyte method was measured using high level human pools. No detectable carryover was observed for reticulocyte counts.
PREPARED SAMPLE STABILITY
Reticulocyte Count
Prepared sample stability over the claimed range of 15 to 90 minutes was tested by assaying 15 prepared samples obtained from apparently healthy donors from 15 to 90 minutes at 15 minute intervals. The test results indicate that all samples were within ±0.5% of the % reticulocyte recovery obtained at 30 minutes.
RBC Indices
With the exception of CH and CHr, the RBC indices are not stable over the entire incubation period. When reporting results for RBC indices other than CH and CHr, the samples should incubate for at least 15 minutes, but not longer than 20 minutes. CH and CHr are stable over the entire 15 to 90 minute incubation period.