(157 days)
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No
The description details a standard HPLC method with pre-set retention time windows and a calibration factor for quantitation. There is no mention of learning algorithms, adaptive models, or any technology typically associated with AI/ML.
No
This device is an in vitro diagnostic (IVD) device used for the determination of hemoglobin Bart's, which is a diagnostic purpose, not a therapeutic one. It analyzes a human sample to provide information, but it does not treat or prevent a disease.
Yes
The device determines the concentration of hemoglobin Bart's in human whole blood, which is then used to diagnose conditions like Alpha-Thalassemia. The "Intended Use / Indications for Use" section explicitly states "The determination of hemoglobin Bart's in human whole blood using ion-exchange HPLC," and the performance studies evaluate its accuracy against another test for "Alpha-Thal Screen."
No
The device description clearly outlines a system that includes hardware components such as an automated analyzer, reagent kit, auto sampler, cartridge, and a dual wavelength photometer, in addition to the software program.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "The determination of hemoglobin Bart's in human whole blood using ion-exchange HPLC." This clearly indicates that the device is used to examine a specimen (human whole blood) obtained from the human body to provide information for diagnostic purposes (determining the presence and quantity of hemoglobin Bart's).
- Device Description: The description details a system that analyzes a biological sample (hemolysate prepared from whole blood) using chemical and physical principles (HPLC, buffer gradient, photometer) to detect and quantify a specific analyte (hemoglobin Bart's). This process is performed in vitro (outside the body).
- Performance Studies: The performance studies evaluate the device's ability to accurately and precisely measure hemoglobin Bart's in human blood samples, which is a key characteristic of an IVD.
- Predicate Device: The mention of a predicate device ("Isolab Alpha-Thal Screen test") which is also an alpha-thalassemia screening test, further supports its classification as an IVD.
The definition of an IVD generally includes devices intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device fits that description perfectly.
N/A
Intended Use / Indications for Use
The determination of hemoglobin Bart's in human whole blood using ion-exchange HPLC.
Product codes
81LGL
Device Description
The VARIANT Alpha-Thalassemia Short Program is designed for use on the fully automated VARIANT analyzer. The analytical system consisting of instrument and reagent kit provides an assay for the detection of hemoglobin Bart's by High Performance Liquid Chromatography (HPLC). The VARIANT Alpha-Thalassemia Short Program utilizes the principles of cation exchange HPLC. A hemolysate is prepared by mixing whole blood with a hemolysis reagent included in the kit. The prepared hemolysate is placed into the instrument's auto sampler. The sampler injects a specified amount of hemolysate onto the cartridge. The separation of normal hemoglobin and Hb Bart's is accomplished on the cation exchange cartridge using a buffer gradient. A dual wavelength photometer (415 and 690 nm) monitors the elution of the separated hemoglobins from the cartridge, detecting absorbance changes at 415nm. The 690 nm secondary filter corrects the baseline for effects caused by the mixing of buffers of different ionic strengths as the gradient is formed.
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
The performance of the VARIANT Alpha-Thalassemia Short Program was evaluated for precision, accuracy, and linearity and recovery.
Precision studies were done according to NCCLS vol. 12 No 4. EPS-T2.
Accuracy was determined by a correlation study against the Isolab Alpha-Thal Screen test. 195 cord blood specimens, including normal, Alpha-Thal 1, Alpha-Thal 2, and Hb H disease patients were analyzed on the VARIANT Alpha-Thalassemia Short and the ISOLAB "Alpha-Thal Screen."
The linearity study was performed to evaluate the response of the VARIANT to increasing concentrations of Hb Bart's. A hydrops sample, which was hemolysed in the Alpha-Thal Short Hemolysis Reagent, was mixed with a normal sample and analyzed.
Key Metrics
Precision: Within-Run Precision values: Low % Hb Bart's SD 0.0 and CV 0.0; Medium % Hb Bart's, SD 0.1 and CV 1.6; High % Hb Bart's SD, 0.2 and CV 1.1. Day-to-Day Precision Values: Low % Hb Bart's SD 0.1 and CV 74.0; Medium % Hb Bart's, SD 0.2 and CV 3.2: High % Hb Bart's, SD 0.7 and CV 3.3.
Accuracy: Statistical comparison of the Hb Bart's values obtained on the VARIANT Alpha-Thalassemia Short and the ISOLAB "Alpha-Thal Screen" yielded a correlation coefficient of 0.977, a y-intercept of 0.79 and a slope of 1.2.
Linearity: The linearity results yielded a correlation coefficient of 1.0, a y-intercept of -0.51 and a slope of 0.99.
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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§ 864.7415 Abnormal hemoglobin assay.
(a)
Identification. An abnormal hemoglobin assay is a device consisting of the reagents, apparatus, instrumentation, and controls necessary to isolate and identify abnormal genetically determined hemoglobin types.(b)
Classification. Class II (special controls). A control intended for use with an abnormal hemoglobin assay is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
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Image /page/0/Picture/0 description: The image shows the logo for BIO-RAD. The logo is white text on a black rounded rectangle. The text is in all caps and is bolded.
Contact Person:
Bio-Rad Laboratories Diagnostics Group 4000 Alfred Nobel Drive Hercules, California 94547 Telephone: 510 724-7000 Fax: 510 741-5824
SUMMARY OF SAFETY AND EFFECTIVENESS
Submitter: Bio-Rad Laboratories, Inc. Clinical Systems Division 4000 Alfred Nobel Hercules, California 94547 Phone 1 510 741-6015 Fax 1 510 741-5824
APR 2 6 1996
Date prepared: November 1995
Product Trade Name: VARIANT Alpha-Thalassemia Short Program
Specialist, Requlatory Affairs
Common Name: VARIANT Hemoglobin Testing System
Kenneth J. Kisco
Classification Name: Abnormal Hemoglobin Assay, 81LGL
The VARIANT Alpha-Thalassemia Short Program is designed for use on the fully automated VARIANT analyzer. The analytical system consisting of instrument and reagent kit provides an assay for the detection of hemoglobin Bart's by High Performance Liquid Chromatography (HPLC).
To establish substantial equivalence to an existing device, and thus establish the safety and effectiveness of the VARIANT Alpha-Thalassemia Short Program, the program has been compared to the Isolab Alpha-Thal Screen test. A review of the intended use of each system shows them to be essentially the same. The intended use of the VARIANT Alpha-Thalassemia Short Program is stated: The determination of hemoglobin Bart's in human whole blood using ion-exchange HPLC. The intended use of the Isolab Alpha-Thal Screen test is stated as: Accurate quantitation of Hemoglobin Bart's in cord blood as an aid to diagnosis of Alpha-Thalassemia.
The VARIANT Alpha-Thalassemia Short Program utilizes the principles of cation exchange HPLC. A hemolysate is prepared by mixing whole blood with a hemolysis reagent included in the kit. The prepared hemolysate is placed into the instrument's auto sampler. The sampler injects a specified amount of hemolysate onto the cartridge. The separation of normal hemoglobin and Hb Bart's is accomplished on the cation exchange cartridge using a buffer gradient. A dual wavelength photometer (415 and 690 nm) monitors the elution of the separated hemoglobins from the cartridge, detecting absorbance changes at 415nm. The 690 nm secondary filter corrects the baseline for effects caused by the mixing of buffers of different ionic strengths as the gradient is formed.
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In the Variant «-Thalassemia Program, Retention Time Windows have been established for the quantitation of Hb Bart's and all non-Bart's hemoglobins, except Hb S and Hb C. These "windows" are expressed in time (minutes and fractions thereof) called retention time. Retention time relates to how long a peak takes from the point of injection to the apex of the peak representing a given hemoglobin. In the Variant «-Thalassemia Program, if a peak occurs within one of these preset windows, it is designated as the hemoglobin corresponding to that window. For example, if a peak falls in the "Bart's window" the report indicates that a peak was detected in the "Bart's window" and prints a quantitative value on the sample report.
For quantitation, a calibrator, with an assigned Hb Bart's value which is entered into the software during setup of the assay, is placed at the beginning of a run. After the analysis of the calibrator, a calibration factor is determined from the ratio of the assigned value to the observed value. This calibration factor is applied to each subsequent sample in the run.
The Isolab Alpha-Thal Screen test utilizes open column liquid chromatography to separate the hemoglobins in the prepared hemolysates. In this test, a hemolysate of whole cord blood is absorbed onto a preconditioned CN-52 cellulose column bed. Hb Bart's is selectively eluted from the column under specific conditions of pH and chloride concentration. Subsequently the non Hb Bart's fraction is eluted from the column. The % Hb Bart's is determined by measurement of the absorption of both fractions at 415nm.
The performance of the VARIANT Alpha-Thalassemia Short Program was evaluated for precision, accuracy, and linearity and recovery. Precision studies were done according to NCCLS vol. 12 No 4. EPS-T2. Within-Run Precision values were: Low % Hb Bart's SD 0.0 and CV 0.0; Medium % Hb Bart's, SD 0.1 and CV 1.6; High % Hb Bart's SD, 0.2 and CV 1.1. Day to Day Precision Values were: Low % Hb Bart's SD 0.1 and CV 74.0; Medium % Hb Bart's, SD 0.2 and CV 3.2: High % Hb Bart's, SD 0.7 and CV 3.3.
Accuracy was determined by a correlation study against the Isolab Alpha-Thal Screen test the results of which are shown in Appendix L. 195 cord blood specimens. including normal. Alpha-Thal 1, Alpha-Thal 2, and Hb H disease patients were analyzed on the VARIANT Alpha-Thalassemia Short and the ISOLAB "Alpha-Thal Screen." Statistical comparison of the Hb Bart's values obtained on the VARIANT Alpha-Thalassemia Short and the ISOLAB "Alpha-Thal Screen" yielded a correlation coefficient of 0.977, a y-intercept of 0.79 and a slope of 1.2.
The linearity study was performed to evaluate the response of the VARIANT to increasing concentrations of Hb Bart's. In this study a hydrops sample, which was hemolysed in the Alpha-Thal Short Hemolysis Reagent, was mixed with a normal sample and analyzed. The measured results from the VARIANT were compared to the theoretical values calculated from the ratio's Hydrops/Normal patient sample. The linearity results yielded a correlation coefficient of 1.0, a y-intercept of -0.51 and a slope of 0.99.
lt can be concluded from the correlation study between the Bio-Rad Variant Alpha-Thal Screen test, and the similarities of the general characteristics, that the two assays are substantially equivalent. Based on the establishment of substantial equivalence, the safety and effectiveness of the Bio-Rad VARIANT Alpha-Thalassemia Short Program is confirmed.