(355 days)
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No
The device description details a chemical and electrical process for separating hemoglobin variants based on their isoelectric points. There is no mention of any computational analysis, pattern recognition, or learning algorithms, which are characteristic of AI/ML. The performance studies focus on method comparison and precision of the physical separation process.
No.
This device is an in vitro diagnostic (IVD) kit used to detect hemoglobin variants as an aid in diagnosing hemoglobinopathies, not to treat a disease or condition.
Yes
The document states that the device "is intended for use as an aid in the diagnosis of neonatal and adult hemoglobinopathies," which directly indicates its diagnostic purpose.
No
The device description clearly outlines a physical kit involving gels, electrical current, and chemical staining for separating and visualizing hemoglobin variants. This is a hardware-based in vitro diagnostic device, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the kit is designed to separate hemoglobin for the detection of normal and variant hemoglobins by isoelectric focusing and is intended for use as an aid in the diagnosis of neonatal and adult hemoglobinopathies. This directly aligns with the definition of an IVD, which is used to examine specimens from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition.
- Intended User / Care Setting: The "Intended User / Care Setting" section states "For in vitro diagnostic use. For professional use only." This is a clear declaration that the device is intended for use in a laboratory or professional setting for diagnostic purposes.
- Device Description: The description details a process of analyzing a biological specimen (whole blood, cord blood, or dried blood spot) using a chemical reaction and physical separation method (isoelectric focusing) to identify components (hemoglobin variants) that are relevant to a medical condition (hemoglobinopathies). This is characteristic of an in vitro diagnostic test.
- Performance Studies: The inclusion of performance studies like method comparison and precision, comparing the device to predicate devices (which are also IVDs), further supports its classification as an IVD. These studies are required for regulatory approval of IVDs to demonstrate their accuracy and reliability.
In summary, the intended use for diagnosis, the explicit statement of "in vitro diagnostic use," and the nature of the test itself all confirm that this device is an IVD.
N/A
Intended Use / Indications for Use
The RESOLVE® Systems Hemoglobin kit is designed to separate whole blood, cord blood or dried blood spot specimen for detection of normal and variant hemoglobins by isoelectric focusing. The kit is designed to be run on a flat-bed electrofocusing unit. This assay is intended for use as an aid in the diagnosis of neonatal and adult hemoglobinopathies.
Product codes (comma separated list FDA assigned to the subject device)
GKA
Device Description
The preparation and separation of hemoglobin is accomplished through the application of a hemoglobin sample onto a precast agarose gel containing RESOLVE Ampholytes pH 6-8. RESOLVE Ampholytes are composed of low molecular weight amphoteric molecules with varying isoelectric points. When an electrical current is applied to the gel, these molecules migrate through the gel to their isoelectric points (pI's) along the gel, forming a stable pH gradient.
The hemoglobin variants also migrate through the gel until they reach the area where their individual pI's equal the corresponding pH on the gel.
At this point, the charges on the variants are zero and migration ceases. The electric field counteracts diffusion and the hemoglobin variant forms a discrete thin band.
Hemoglobin bands are visualized by using the JB-2 Staining System containing o-dianisidine. o-dianisidine, the active component of the Gel Stain Concentrate, is oxidized in the presence of hydrogen peroxide at the site of hemoglobin. This reaction produces an insoluble, colored precipitate proportional to the amount of hemoglobin.
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
Neonates and also adults
Intended User / Care Setting
For in vitro diagnostic use. For professional use only.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Method comparison: The method comparison of the RESOLVE® Hb kit to predicate device was performed at three sites. Two of these used the BioRad's HPLC method VARIANT Sickle Cell Short Program (1) as a comparative method and one site used the VARIANT nbs Sickle Cell Program (2). The studied samples were either routine DBS samples or retrospective samples. More than half of the samples were normal samples (FA). The rest of the samples had hemoglobin combinations with Hb S or hemoglobin combinations with other Hb variants such as Hb C, Hb D, Hb E. Hb G-Philadelphia, alpha-thalassemia and beta-thalassemia.
Study 1: Number of specimens 850, HPLC method 1, Agreement -% 99.8, 95% lower CL 99.2
Study 2: Number of specimens 837, HPLC method 2, Agreement -% 97.7, 96.7
Study 3: Number of specimens 1031, HPLC method 1, Agreement -% 99.1, 98.4
Precision: The precision study was based on the results obtained from the comparison studies with the predicate devices. The variation was estimated by measuring the distance of certain Hb bands of FASC controls used in the studies. The analysis of variance approach was used to calculate the following variations:
Hb A1c vs. Hb C: Number of specimens 216, Average distance (mm) 17.8, Within-gel precision (CV%) 2.2, Between-gel precision (CV%) 1.8, Total precision within laboratory (CV%) 2.8
Hb A vs. Hb F: Number of specimens 223, Average distance (mm) 2.1, Within-gel precision (CV%) 3.3, Between-gel precision (CV%) 2.9, Total precision within laboratory (CV%) 4.4
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Agreement -% ranged from 97.7% to 99.8%.
Precision (CV%) ranged from 2.8% to 4.4%.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
BioRad VARIANT Sickle Cell Short Program K924813, BioRad VARIANT nbs Sickle Cell Program K051072
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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 Perkin precisely. The logo consists of a bold, black letter 'P' with a triangular shape pointing to the right, positioned above the word 'Perkin' in a bold, sans-serif font. Below and to the right of 'Perkin', the word 'precisely' is written in a smaller, lighter font.
MAR 8 2006 kin Elmer Life and Analytical Sciences 20101 Turku Finland
510(k) SUMMARY
(as required by 21 CFR 807.92)
The assigned 510(k) number is: K050709
- Submitted by: Raija Koskivaara Registration Manager Wallac Oy Mustionkatu 6, 20750 Turku P.O. Box 10, 20101 Turku Finland
- RESOLVE® Hemoglobin kit Device Name:
Isoelectric focusing of hemoglobins Common Name:
Abnormal hemoglobin assay Classification: Class II per 21 CFR § 862.7415
- Product Code: GKA
- BioRad VARIANT Sickle Cell Short Program K924813 Predicate Device: BioRad VARIANT nbs Sickle Cell Program K051072
Device Description:
The preparation and separation of hemoglobin is accomplished through the application of a hemoglobin sample onto a precast agarose gel containing RESOLVE Ampholytes pH 6-8. RESOLVE Ampholytes are composed of low molecular weight amphoteric molecules with varying isoelectric points. When an electrical current is applied to the gel, these molecules migrate through the gel to their isoelectric points (pl's) along the gel, forming a stable pH gradient.
The hemoglobin variants also migrate through the gel until they reach the area where their individual pl's equal the corresponding pH on the gel.
1
Image /page/1/Picture/0 description: The image shows a logo with the word "Perkin" in bold, black letters. Above and to the right of the word "Perkin" is a stylized symbol that resembles a capital "P" with a triangle pointing to the right. Below and to the right of the word "Perkin" is the word "precisely" in a smaller, lighter font. The logo appears to be for a company or brand named "Perkin".
At this point, the charges on the variants are zero and migration ceases. The electric field counteracts diffusion and the hemoglobin variant forms a discrete thin band.
Hemoglobin bands are visualized by using the JB-2 Staining System containing o-dianisidine. o-dianisidine, the active component of the Gel Stain Concentrate, is oxidized in the presence of hydrogen peroxide at the site of hemoglobin. This reaction produces an insoluble, colored precipitate proportional to the amount of hemoglobin.
Indications for Use:
The RESOLVE® Systems Hemoglobin kit is designed to separate whole blood, cord blood or dried blood spot specimen for detection of normal and variant hemoglobins by isoelectric focusing. The kit is designed to be run on a flat-bed electrofocusing unit. This assay is intended for use as an aid in the diagnosis of neonatal and adult hemoglobinopathies.
Comparison with Predicate Devices:
| Features | Device
RESOLVE® Hb kit | Predicate Device
Bio-Rad VARIANT
Sickle Cell Short
Program (K924813) | Predicate Device
Bio-Rad VARIANT
nbs Sickle Cell
Program (K051072) |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| A. Similarities | | | |
| Intended Use | The RESOLVE®
Systems Hemoglobin
kit is designed to
separate whole
blood, cord blood or
dried blood spot
specimen for
detection of normal
and variant
hemoglobins by
isoelectric focusing.
This assay is
intended for use as
an aid in the
diagnosis of neonatal
and adult
hemoglobinopathies. | The VARIANT Sickle
Cell Short Program is
designed as a
qualitative screen for
the presence of
hemoglobins
F,A,S,D,C and E in
eluates of neonatal
blood collected on
filter paper by high
performance liquid
chromatography
(HPLC). | The VARIANT nbs
Sickle Cell Program
is designed as a
qualitative screen for
the presence of
hemoglobins
F,A,S,D,C and E in
eluates of neonatal
blood collected on
filter paper by high
performance liquid
chromatography
(HPLC). |
| Human Factors | For in vitro diagnostic
use. For professional
use only. | For in vitro diagnostic
use. For professional
use only. | For in vitro diagnostic
use. For professional
use only. |
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Image /page/2/Picture/0 description: The image shows a logo with a thick black vertical bar and a right-pointing triangle. To the left of the bar and triangle is the word "Perkin" in bold black letters. Below and to the right of the word "Perkin" is the word "precisely." in a smaller font.
| Design- analytes
identified | Hemoglobins F, A, E,
D, S, C. In addition G
and α- and β-
thalassemia (e.g. Hb
Bart's and HbH) can
be identified. | Six retention time
windows for
hemoglobins F, A, E,
D, S and C are
shown. | Six retention time
windows for
hemoglobins F, A, E,
D, S and C are
shown. |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Design- sample
type | Neonatal dried blood
spots on filter paper
and in addition whole
blood and cord blood
specimen. | Neonatal dried blood
spots on filter paper
collection cards. | Neonatal dried blood
spots on filter paper
collection cards. |
| Design- target
population | Neonates and also
adults | Neonates | Neonates |
| Performance-
precision | Total precision within
laboratory:
Hb A1C vs C: 2.82%
Hb A vs F: 4.36% | Peak retention time
precision is (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K050709 |