(219 days)
Ames DCA 2000® Hemoglobin method
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No
The summary describes a standard in vitro diagnostic assay for measuring HbA1c and Total Hemoglobin using established laboratory methods and instrumentation, with no mention of AI or ML.
No.
The device is an in vitro diagnostic method used to measure Hemoglobin A1c and Total Hemoglobin for monitoring long-term care of persons with diabetes, which is a diagnostic function, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section explicitly states, "This in vitro diagnostic method is intended to quantitatively measure Hemoglobin Alc (HbA1c) and Total Hemoglobin (Thb) in human blood..." which clearly indicates it is a diagnostic device used for medical purposes.
No
The device is an in vitro diagnostic method that measures analytes in human blood using a specific instrument system (Technicon RA family/opeRA). This indicates it involves hardware and chemical reagents, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that this is an "in vitro diagnostic method" and that it is intended to measure substances (Hemoglobin A1c and Total Hemoglobin) in "human blood," which is a sample taken from the human body.
- Measurement in vitro: The term "in vitro" means "in glass" or "outside the body." The method described involves analyzing a blood sample outside of the patient's body.
- Purpose: The measurements are used for "monitoring the long-term care of persons with diabetes," which is a medical purpose.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This in vitro diagnostic method is intended to quantitatively measure Hemoglobin Alc (HbA1c) and Total Hemoglobin (Thb) in human blood on the Technicon RA family/opeRA instrument systems. Measurements obtained through this procedure can be used for monitoring the long-term care of persons with diabetes.
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
Performance comparison between Technicon RA®/opeRA™ Systems Hemoglobin A1c/Total Hemoglobin assays and the Ames DCA 2000® Hemoglobin method for Hemoglobin A1c, and comparison to NCCLS Reference Method, Thb Document H15 - A2, Vol 14, No. 6, May 1994 for Total Hemoglobin.
Hemoglobin A1c:
Precision:
RA/opeRA: Mean %: 5.7, Total CV%: 3.1; Mean %: 8.9, Total CV%: 2.6; Mean %: 11.6, Total CV%: 2.0
DCA 2000: Mean %: 5.2, Total CV%: 3.5-5.6; Mean %: 8.2, Total CV%: 2.4-4.9; Mean %: 12.0, Total CV%: 3.3-4.9
Analytical Range: RA/opeRA: 2.5 - 18%; DCA 2000: 2.5 - 14.0%
Correlation (y = RA/opeRA, x = DCA 2000): y = 1.09 x -0.39, n = 154, r = 0.99, Syx = 0.36
Expected Values: RA/opeRA: 4.4 - 6.0 %; DCA 2000: 4.5 - 5.7%
Total Hemoglobin (RA/opeRA):
Precision: Mean g/dL: 10.6, Within-Run CV%: 0.6; Mean g/dL: 15.3, Within-Run CV%: 0.7; Mean g/dL: 18.6, Within-Run CV%: 0.9
Analytical Range: 7 - 23 g/dL
Correlation (y = RA/opeRA, x = NCCLS method): y = 0.96 x 0.13, n = 50, r = 0.988, Syx = 0.65
Expected Values: 12.3 - 17.9 g/dL
Key Metrics
Hemoglobin A1c: Precision (Total CV%), Analytical Range (%), Correlation (r, Syx), Expected Values (%)
Total Hemoglobin: Precision (Within-Run CV%), Analytical Range (g/dL), Correlation (r, Syx), Expected Values (g/dL)
Predicate Device(s)
Ames DCA 2000® Hemoglobin method
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 864.7470 Glycosylated hemoglobin assay.
(a)
Identification. A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a , A1b , and A1c ) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.(b)
Classification. Class II (performance standards).
0
Enclosure 8
JUN 13 1996
Attachment 3
SUMMARY OF SAFETY AND EFFECTIVENESS
Hemoglobin A1c (%)
Listed below is a comparison of the performance between the Technicon RA®/opeRA™ Systems Hemoglobin A1c/Total Hemoglobin assays and the similar device assay system that was granted FDA clearance of substantial equivalence (Ames DCA 2000® Hemoglobin method). The information provided in this summary was extracted from the Technicon RA@/opeRA™ Systems Hemoglobin A1c/Total Hemoglobin method sheet and the Ames DCA 2000® Hemoglobin A1c method sheet (Attachments 1 & 2).
INTENDED USE
1 1100
This in vitro diagnostic method is intended to quantitatively measure Hemoglobin Alc (HbA1c) and Total Hemoglobin (Thb) in human blood on the Technicon RA family/opeRA instrument systems. Measurements obtained through this procedure can be used for monitoring the long-term care of persons with diabetes.
| METHOD | RA/opeRA | HbAlc | DCA 2000 | HbAlc |
|---|---|---|---|---|
| Precision | Mean % | Total CV% | Mean % | Total CV % |
| 5.7 | 3.1 | 5.2 | 3.5-5.6 | |
| 8.9 | 2.6 | 8.2 | 2.4-4.9 | |
| 11.6 | 2.0 | 12.0 | 3.3-4.9 | |
| Analytical | ||||
| Range | 2.5 - 18% | 2.5 - 14.0% | ||
| Correlation | y = RA/opeRA | |||
| x = DCA 2000 | y = 1.09 x -0.39 | |||
| n = 154 | ||||
| r = 0.99 | ||||
| Syx = 0.36 | ||||
| Expected | ||||
| Values | 4.4 - 6.0 % | 4.5 - 5.7% |
1
Attachment 3
SUMMARY OF SAFETY AND EFFECTIVENESS
Total Hemoglobin (g/dl)
| METHOD | RA/opeRA Thb |
|---|---|
| -------- | -------------- |
)
NCCLS Reference Method, Thb Document H15 - A2, Vol 14, No. 6, May 1994
| Precision | Mean g/dL | Within-Run CV% |
|---|---|---|
| 10.6 | 0.6 | |
| 15.3 | 0.7 | |
| 18.6 | 0.9 | |
| Analytical | ||
| Range | 7 - 23 g/dL | |
| Correlation | ||
| y = RA/opeRA y = 0.96 x 0.13 | ||
| x = NCCLS method n = 50 | ||
| r = 0.988 Syx = 0.65 | ||
| Expected |
Values 12.3 - 17.9 g/dL
updated 5/21/96,gm.