(30 days)
Not Found
No
The document describes a software upgrade for an existing HPLC system, primarily focused on migrating to a newer operating system (Windows XP). There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies. The core technology remains HPLC for separating hemoglobins.
No
This device is an in vitro diagnostic (IVD) screening tool used to identify the presence of specific hemoglobins from neonatal blood samples, which can indicate sickle cell disease or trait, but it does not provide treatment or directly interact with the patient as a therapeutic device would.
Yes
The device is intended as a qualitative screen for the presence of specific hemoglobins, and the presence of HbS is indicative of sickle cell disease or trait, which allows for proactive treatment. This clearly points to a diagnostic purpose. The text also explicitly states "For In Vitro Diagnostic Use."
No
The device description explicitly states that the system uses high-performance liquid chromatography (HPLC) and a cation exchange cartridge for separation, which are hardware components. The submission focuses on a software upgrade (GDM 3.0) for data management, but the core function relies on physical separation technology.
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 performs a qualitative screen for the presence of specific hemoglobins in blood samples. This is a laboratory test performed outside of the body, which is the definition of an in vitro diagnostic.
- Intended Use: The purpose of the test is to aid in the diagnosis of sickle cell disease or sickle cell trait, which is a diagnostic purpose.
- Professional Use Only: The indication for "Professional Use Only" is consistent with IVD devices that require trained personnel to operate and interpret results.
N/A
Intended Use / Indications for Use
The Bio-Rad VARIANT™nbs 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.
The presence of hemoglobin S (HbS) in a patient blood sample is indicative of sickle cell disease or sickle cell trait. Diagnosis of sickle cell disease prior to the age of four months allows for the administration of a prophylactic treatment with penicillin. Prophylactic treatment with penicillin has shown to decrease morbidity and mortality.
Product codes (comma separated list FDA assigned to the subject device)
GKA
Device Description
The VARIANTnbs Newborn Screening System uses the principles of high-performance liquid chromatography (HPLC). The VARIANTnbs Sickle Cell Program is based on the chromatographic separation of hemoglobins F, A, S, D, C, and E on a cation exchange cartridge.
The new feature in this submission is the upgrade of the Genetic Data Management (GDM) software. The current software (GDM 2.01) requires Microsoft Windows NT. This product is nearing the end of its lifecycle. GDM 3.0 software is needed to transfer the GDM software to the Microsoft Windows XP Operating System.
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
neonatal
Intended User / Care Setting
Professional Use Only. For In Vitro Diagnostic Use.
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)
A method correlation study between the VARIANTnbs Sickle Cell Program with GDM 3.0 and the VARIANTnbs Sickle Cell Program with GDM 2.01 was conducted at an external site to demonstrate equivalence. Samples run on the predicate device were repeated on the GDM 3.0 platform on the same day.
Patient Sample Type Agreement: EA (100%), FAS (100%), FAC (100%), FAD (100%), A (100%).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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).
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
Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K 0809 /
: Submitter:
Bio-Rad Laboratories, Inc., Clinical Systems Division, 4000 Alfred Nobel Drive, Hercules, California 94547
Phone: (510) 741-6114, Fax: (510) 741-6471
Contact Person:
Jolene Bartilson, Regulatory Affairs Representative
Device Name:
VARIANT™nbs Sickle Cell Program run on the VARIANT™nbs Newborn Screening System using Genetic Data Management (GDM) 3.0 Software
Classification Name:
Assay, Abnormal Hemoglobin, GKA
Predicate Device(s):
VARIANTTMnbs Sickle Cell Program, Bio-Rad Laboratories, Inc., K051072
Intended Use:
The Bio-Rad VARIANT™nbs 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.
Indications for Use;
The presence of hemoglobin S (HbS) in a patient blood sample is indicative of sickle cell disease or sickle cell trait. Diagnosis of sickle cell disease prior to the age of four months
1
treatment with penicillin has shown to decrease morbidity and mortality. 1
- Gaston, M.H.; Verter, J.I.; Woods, G .; Pegelow, C .; Kelleher, J .; Presbury, G .; Zarkowsky, H.; Vichinsky, E.; Lyer, R.; Lobel, J.S.; Diamond, S.; Holbrook, C.T.; Gill, F.M .; Ritchey, K .; Falleta, J.M. Prophylaxis With Oral Penicillin in Children With Sickle Cell Anemia: A Randomized Trial. N. Engl. J. Med. 1986, 314 (25), 1593-1599.
Description of the Device:
The VARIANTnbs Newborn Screening System uses the principles of high-performance liquid chromatography (HPLC). The VARIANTnbs Sickle Cell Program is based on the chromatographic separation of hemoglobins F, A, S, D, C, and E on a cation exchange cartridge.
The new feature in this submission is the upgrade of the Genetic Data Management (GDM) software. The current software (GDM 2.01) requires Microsoft Windows NT. This product is nearing the end of its lifecycle. GDM 3.0 software is needed to transfer the GDM software to the Microsoft Windows XP Operating System.
Technical Characteristics Compare to the Predicate:
The VARIANTnbs Sickle Cell Program runs on the VARIANTnbs Newborn Screening System with GDM 3.0 and has the same basic technical characteristics as the predicate VARIANTnbs Sickle Cell Program, K051072. The technical characteristics between the two submissions are summarized in the following table:
| Characteristic | New Device: VARIANTnbs Sickle Cell Program
run on the VARIANTnbs Newborn Screening
System with GDM 3.0 | Predicate Device: VARIANTnbs Sickle Cell
Program run on the VARIANTnbs Newborn
Screening System with GDM 2.01 (K051072) |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use | The Bio-Rad VARIANT™nbs
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. | The Bio-Rad VARIANT™nbs
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. |
| Indications | The presence of hemoglobin S | The presence of hemoglobin S |
2
| for Use | (HbS) in a patient blood sample is
indicative of sickle cell disease or
sickle cell trait. Diagnosis of sickle
cell disease prior to the age of four
months allows for the
administration of a prophylactic
treatment with penicillin.
Prophylactic treatment with
penicillin has shown to decrease
morbidity and mortality.1 | (HbS) in a patient blood sample is
indicative of sickle cell disease or
sickle cell trait. Diagnosis of sickle
cell disease prior to the age of four
months allows for the
administration of a prophylactic
treatment with penicillin.
Prophylactic treatment with
penicillin has shown to decrease
morbidity and mortality.1 |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Assay
Principle | Cation exchange high-performance
liquid chromatography | Cation exchange high-performance
liquid chromatography |
| Operating
System | Microsoft Windows XP | Microsoft Windows NT |
| ObjectStore | ObjectStore Version 6.2 | ObjectStore Version 4.0 |
| Barcode
Reader | Active | Inactive |
| Worklist
Setup | Improved to provide flexibility in
the setup and a simplified daily
workflow | Feature not available |
| XtraGrid
Control | XtraGrid Control OTS Software
(version 2.1.1) added to manage
data represented in the Worklist
Setup tables | Not included, Worklist Setup
feature not available |
| Archive
Viewer | Standalone software application
that allows the user to view a
database from an earlier GDM
software version | Feature not available |
! Testing to Establish Substantial Equivalence: Correlation:
A method correlation study between the VARIANTnbs Sickle Cell Program with GDM 3.0 and the VARIANTnbs Sickle Cell Program with GDM 2.01 was conducted at an external site to demonstrate equivalence. Samples run on the predicate device were repeated on the GDM 3.0 platform on the same day. Below is a representation of the results from this study.
| Vnbs Sickle Cell Program with GDM 3.0 vs. Vnbs Sickle Cell Program with GDM 2.0 | |
|---|---|
| --------------------------------------------------------------------------------- | -- |
| Patient Sample | GDM 2.01 | GDM 3.0 (New | Agreement |
|---|---|---|---|
| Type | (Predicate) | Device) | 0/0 |
| E A | t | ||
| Sept. However, House, Market, Market, Market, Market, Market, Market, Market, Market, Market, Market, Market, Market, Market, Market, Market, Market, Market, Market, Market, | t | ||
| 2000 | 100% |
3
| FAS | 100% | |
|---|---|---|
| FAC | 100% | |
| FAD | 100% | |
| A | ||
| mind Transformer of It is in the | ||
| HS | 100% | |
| Total | «««««««««««««««««««««««««««««««««««««««««««««««««««««««««««««««««««««««««««««««««««««««««««««««««««»»»»»»»»»»»»»»»» ««««««««««««««««««««««««««««»»»»»»»»»»»»»»» «««««««««««««« | 11 Specificant F. REVEREAL ARTIN' (REPORTER P |
Conclusion:
I The modifications to the VARIANTnbs Sickle Cell Program run on the
VARIANTubs Newborn Screening System with GDM 3.0 do not affect the intended use or indications for use of the device as described in the labeling, raise any new issues of safety or effectiveness, nor do they alter the fundamental scientific technology of the device. Therefore, we trust that the information provided in this Special 510(k) submission will support a decision of substantial equivalence of the VARIANTnbs Sickle Cell Program run on the VARIANTnbs Newborn Screening System with GDM 3.0 to its predicate.
0
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is in black and white.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY - 2 2008
Bio-Rad Laboratories, Inc. Clinical Systems Division C/O J.B. Bartilson 4000 Alfred Nobel Drive Hercules, California 94547
Re: K080911
Trade/Device Name: Variant NBS Sickle Cell Program Reagent Kit, Variant NBS Newborn Screening Regulation Number: 21 CFR 864.7415 Regulation Name: Abnormal Hemoglobin Assay Regulatory Class: Class II Product Code: GKA Dated: April 1, 2008 Received: April 2, 2008
Dear J.B. Bartilson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice
5
Page 2 - Bio-Rad Laboratories, Inc.
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to procced to the market.
If vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Robert M. Roskel
Robert L. Becker, Jr., M.D./Ph.D. Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): K0809 / /
Device Name: VARIANT™nbs Sickle Cell Program run on the VARIANT™abs Newborn Screening System using Genetic Data Management (GDM) 3.0 Software
Indications for 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 Bio-Rad VARIANT™nbs Sickle Cell Program is intended for Professional Use Only. For In Vitro Diagnostic Use.
The Bio-Rad VARIANT™nbs Sickle Cell Program is for use only with the Bio-Rad VARIANT™nbs Newborn Screening System.
Prescription Use X (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K080911