(16 days)
No
The description details a standard HPLC system with software that uses pre-determined windows and "pattern rules" derived from literature for qualitative screening, not AI/ML algorithms.
No
This device is for in vitro diagnostic use, specifically for qualitative screening of hemoglobins, not for direct therapeutic intervention on a patient.
Yes
The Intended Use / Indications for Use statement explicitly states, "The Bio-Rad VARIANTnbs Sickle Cell Program is intended as a qualitative screen for the presence of hemoglobins F, A, S, D, C and E...For In Vitro Diagnostic Use." This indicates its purpose is to identify or detect biological markers for medical diagnosis.
No
The device description clearly outlines a hardware system (HPLC System, auto sampler, chromatography station, analytical cartridge, buffers, photometer) that the software (GDM software) operates. The software is an integral part of a larger hardware system, not a standalone software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For In Vitro Diagnostic Use."
- Nature of the Test: The device analyzes biological samples (neonatal blood) in vitro (outside the body) to screen for the presence of specific hemoglobins, which are indicators of a medical condition (sickle cell disease).
- Intended Purpose: The purpose is to provide information for the diagnosis or screening of a disease or condition.
Therefore, based on the provided information, the Bio-Rad VARIANTnbs Sickle Cell Program is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Bio-Rad VARIANTnbs Sickle Cell Program is intended 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 Bio-Rad VARIANTnbs Sickle Cell Program is intended for Professional Use Only. For In Vitro Diagnostic Use.
The Bio-Rad VARIANTnbs Sickle Cell Program is for use only with the Bio-Rad VARIANTnbs Newborn Screening System.
Product codes
GKA
Device Description
The VARIANTnbs Newborn Screening System is a High Performance Liquid Chromatography (HPLC) System consisting of an auto sampler for microwell plates (VARIANTnbs Neonatal Auto Sampler) and a chromatography station (VARIANTnbs Chromatography Station). The VARIANTnbs Sickle Cell Program, which operates on the VARIANTnbs Chromatography Station, includes an analytical cartridge containing cation exchange resin and two (2) buffers for establishing a gradient. The Genetic Data Management (GDM) software is designed to operate on the VARIANTnbs Newborn Screening System for the purposes of qualitatively screening for the presence of normal hemoglobins F and A and abnormal hemoglobins S, D, C and E by means of one or two 1/8" discs punched from neonatal heel stick blood collected on filter paper by the Genetic Data Management (GDM) software. Sample aliquots, either aspirated directly from microwell plates with the filter paper disc still present, or eluates, are collected in a sample loop and then injected into the flow path of the chromatography module. The sample is then passed on the analytical cartridge in the presence of Elution Buffer 1. The ionic strength is subsequently raised by adding increasing amounts of Elution Buffer 2. The program is designed to have the hemoglobins of interest elute from the cartridge with characteristic retention times that fall within pre-determined windows characteristic of known hemoglobins. Eluted hemoglobins are detected with a dual-wavelength filter photometer which monitors hemoglobin absorbance at 415 mm and corrects for any gradient induced absorbance changes at 690 nm. Processed data is output in a printed report that contains 1) sample identification, 2) date and time of analysis, 3) a peak table containing observed peak name(s), retention time(s), peak height(s), peak area(s), and relative area percent(s), 4) total chromatogram area, 5) chromatogram and 6) any error message(s). Also reported is an optional "pattern assignment" based upon "pattern rules" derived from literature.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Neonates
Intended User / Care Setting
Professional Use Only.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Correlation:
Method correlation between predicate device and Bio-Rad VARIANTnbs Sickle Cell Program new device was performed using 935 samples prepared from neonatal dried blood spot collection cards.
| Number of Samples | Predicate Device F, A, E, D, S and (or) C Identified | New device Agree | Disagree |
|---|---|---|---|
| 591 | FA | 590 | 1 (FAS) |
| 52 | FAE | 52 | 0 |
| 38 | FAD | 37 | 1 (FADC) |
| 247 | FAS | 247 | 0 |
| 90 | FAC | 90 | 0 |
| 3 | FSC | 3 | 0 |
| 2 | FC | 2 | 0 |
| 1 | FE | 1 | 0 |
| 1 | F | 1 | 0 |
Precision:
The Bio-Rad VARIANTnbs Sickle Cell Program new device retention time precision protocol was based on NCCLS Protocol EP5-A (Vol. 19, No. 2) and EP5-A2 (Vol. 24, No. 25). Two analytical runs were performed per day on 20 days for a total of 40 runs on each of 3 separate systems. Each run included 4 replicates of two retention time positional QC controls. Within-run precision and within-device precision (formerly total precision) were determined.
Retention Time With-in Run Precision Summary (CV %):
- New Device (160 x 3 Replicates):
- QC Control 1: Peak F (0.3-0.5), Peak A (0.3-0.4), Peak E (0.3-0.4), Peak S (0.2-0.3)
- QC Control 2: Peak F (0.3-0.5), Peak A (0.3-0.4), Peak D (0.2-0.3), Peak C (0.1-0.3)
- Predicate Device (10 x 1 Replicates):
- QC Control 1: Peak F (0.7), Peak A (0.0), Peak E (0.0), Peak S (0.0)
- QC Control 2: Peak F (0.6), Peak A (0.0), Peak D (0.4), Peak C (0.3)
Retention Time With-in Device Precision (CV %):
- New Device (160 x 3 Replicates):
- QC Control 1: Peak F (0.3-0.6), Peak A (0.4-0.6), Peak E (0.4-0.6), Peak S (0.5-0.6)
- QC Control 2: Peak F (0.3-0.7), Peak A (0.4-0.6), Peak D (0.4-0.5), Peak C (0.2-0.3)
Variant Peak Area Limit of Detection:
The Bio-Rad VARIANTnbs Sickle Cell Program new device peak area limit of detection for hemoglobin variants (E, D, S and C) was determined using a total of 102 sample measurements (comprised of 3 measurements each of 34 samples: 10 S, 8 D, 8 C, and 8 E variants). The limit of detection for each variant was 1% when the total chromatogram area was 1.5 million microvolt second. The reported predicate device peak area limit of detection was 1% when the total chromatogram area was 1.0 million microvolt second.
| Device | Chromatogram Total Area (microvolt·second) | Peak Area% Limit of Detection Peak E | Peak D | Peak S | Peak C |
|---|---|---|---|---|---|
| New | 1.5 | 1% | 1% | 1% | 1% |
| Predicate | 1.0 | 1% | 1% | 1% | 1% |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
K 05/072
Section E
510(k) Summary of Safety and Effectiveness
For
VARIANT™nbs Sickle Cell Program
Bio-Rad Laboratories, Inc. Bio-Rad VARIANTnbs Sickle Cell Program 510(k) (Revision: April 11, 2005)
1
510(k) Summary of Safety and Effectiveness
Submitter
Address:
Phone: Facsimile: Bio-Rad Laboratories, Inc. Clinical Systems Division 4000 Alfred Nobel Drive Hercules, CA 94547 U.S.A. (510) 724-7000 (510) 741-6471
William Gary Gustafson
Regulatory Affairs Representative
Contact Person
Phone: Facsimile: E-Mail:
Preparation Date
March 17, 2005
(510) 741-6114
(510) 741-6471
New device Name
| Trade Name: | Bio-Rad VARIANT™nbs Sickle Cell Program |
|---|---|
| Common Name: | Hemoglobin F, A, S, D, C and E Determination by HPLC |
| Classification Name: | Abnormal Hemoglobin Quantitation (21 CFR 864.7415) |
Predicate Device Name
| Trade Name: | Bio-Rad VARIANT™ Sickle Cell Short Program |
|---|---|
| Classification Name: | Abnormal Hemoglobin Quantitation (21 CFR 864.7415) |
| Applicant: | Bio-Rad Laboratories, Inc. |
| 510(k) Number: | K924813 |
Indications for Use Statement and Intended Uses
The Bio-Rad VARIANTnbs Sickle Cell Program is intended 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 Bio-Rad VARIANTnbs Sickle Cell Program is intended for Professional Use Only. For In Vitro Diagnostic Use.
The Bio-Rad VARIANTnbs Sickle Cell Program is for use only with the Bio-Rad VARIANTnbs Newborn Screening System.
2
New Device Description
The VARIANTnbs Newborn Screening System is a High Performance Liquid Chromatography (HPLC) The Vitting of an auto sampler for microwell plates (VARIANTnbs Neonatal Auto Sampler) and a System consisting of an and and Chromatography Station). The VARIANTnbs Sickle entonategrapity atation ( withat includes an analytical cartridge containing cation exchange resin and two (2) buffers for establishing a gradient. The Genetic Data Management (GDM) software is designed two (2) batter for Calabilanting agains on the VARIANTnbs Newborn Screening System for the purposes of qualitatively screening for the presence of normal hemoglobins F and A and abnormal the purposes of quartain roy releases of discs punched from neonatal heel stick blood collected on filter nenogrooms by of one aspirated directly from microwell plates with the filter paper disc still present, collected in a sample loop and then injected into the flow path of the chromatography module. The benoctod in a campe to para med on the analytical cartridge in the presence of Elution Buffer 1. The nonic strength is subsequently raised by adding increasing amounts of Elution Buffer 2. The preromo strengin is designed to have the hemoglobins of interest elute from the cartridge with programmon great fall within pre-determined windows characteristic of known hemoglobins. Eluted hemoglobins are detected with a dual-wavelength filter photometer which monitors hemoglobin absorbance at 415 mm and corrects for any gradient induced absorbance changes at 690 nm. Processed data is output in a printed report that contains 1) sample identification, 2) date and time of analysis, 3) a peak table containing observed peak name(s), retention time(s), peak height(s), peak area(s), and relative area percent(s), 4) total chromatogram area, 5) chromatogram and 6) any error message(s). Also reported is an optional "pattern assignment" based upon "pattern rules" derived from literature.
| Summary of Technological Characteristic Similarities to Predicate Device | ||
|---|---|---|
| Features | New Device: | |
| Bio-Rad VARIANTTMnbs Sickle Cell | ||
| Program | Predicate Device: | |
| Bio-Rad VARIANTTM Sickle Cell Short | ||
| Program | ||
| (K#924813) | ||
| Intended Use | The Bio-Rad VARIANTTMnbs Sickle Cell | |
| Program is intended 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 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. | ||
| For In Vitro Diagnostic Use. | For In Vitro Diagnostic Use. | |
| For Professional Use Only. | For Professional Use Only. | |
| Target Population | Neonates. | Neonates. |
| Design - Assay principle | Cation exchange high performance liquid | |
| chromatography. | Cation exchange high performance liquid | |
| chromatography. | ||
| Design - Assay Detection | Heme absorbance at 415 nm with | |
| background correction at 650 nm. | Heme absorbance at 415 nm with | |
| background correction at 650 nm. | ||
| Design - Analytes | ||
| Identified | Six retention time windows for | |
| hemoglobins F, A, E, D, S and C. | Six retention time windows for | |
| hemoglobins F, A, E, D, S and C. | ||
| Design - Sample Type | Neonatal dried blood spots on filter paper | |
| collection cards. | Neonatal dried blood spots on filter paper | |
| collection cards. | ||
| Design - Punched Disc | One 1/8" disc. | One 1/8" disc. |
Comparison with Predicate Device
3
| Summary of Technological Characteristic Similarities to Predicate Device | ||
|---|---|---|
| Features | New Device: | |
| Bio-Rad VARIANTTMnbs Sickle Cell | ||
| Program | Predicate Device: | |
| Bio-Rad VARIANTTM Sickle Cell Short | ||
| Program | ||
| (K#924813) | ||
| Design - Manual Worklists | Accepts manual worklists. | Accepts manual worklists. |
| Materials - Components | Elution Buffer 1. Elution Buffer 2. | |
| Wash Solution. Analytical Cartridge. | ||
| Lyophilized Whole Blood Primer. | ||
| Lyophilized Retention Time Marker 1 | ||
| (FAES). Lyophilized Retention Time | ||
| Marker 2 (FADC). | Elution Buffer 1. Elution Buffer 2. | |
| Wash Solution. Analytical Cartridge. | ||
| Lyophilized Whole Blood Primer. | ||
| Lyophilized Retention Time Marker 1 | ||
| (FAES). Lyophilized Retention Time | ||
| Marker 2 (FADC). | ||
| Performance -- Precision | Peak retention time precision is |