(16 days)
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.
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 consists of 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 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 in eluates of discs punched from neonatal heel stick blood collected on filter paper or 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 hemoglobins are bound 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 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.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Predicate Device) | Reported Device Performance (New Device) |
|---|---|---|
| Correlation | Not explicitly defined, but implied by substantial equivalence to K924813. | High agreement with predicate device: 590/591 (FA), 52/52 (FAE), 37/38 (FAD), 247/247 (FAS), 90/90 (FAC), 3/3 (FSC), 2/2 (FC), 1/1 (FE), 1/1 (F). |
| Precision (Retention Time, within-run) | Peak retention time precision <1% for all hemoglobin peaks. | QC Control 1: Peak F (0.3-0.5 CV%), Peak A (0.3-0.4 CV%), Peak E (0.3-0.4 CV%), Peak S (0.2-0.3 CV%). QC Control 2: Peak F (0.3-0.5 CV%), Peak A (0.3-0.4 CV%), Peak D (0.2-0.3 CV%), Peak C (0.1-0.3 CV%). All within <1%. |
| Precision (Retention Time, within-device) | Not explicitly reported for predicate device, implied by substantial equivalence. | QC Control 1: Peak F (0.3-0.6 CV%), Peak A (0.4-0.6 CV%), Peak E (0.4-0.6 CV%), Peak S (0.5-0.6 CV%). QC Control 2: Peak F (0.3-0.7 CV%), Peak A (0.4-0.6 CV%), Peak D (0.4-0.5 CV%), Peak C (0.2-0.3 CV%). All within <1%. |
| Variant Peak Area Limit of Detection | 1% of total area when total chromatogram area is 1.0 million microvolt·second. | 1% of total area when total chromatogram area is 1.5 million microvolt·second for E, D, S, and C. |
2. Sample Size and Data Provenance for Test Set
- Sample Size:
- Correlation Study: 1035 samples (591 FA, 52 FAE, 38 FAD, 247 FAS, 90 FAC, 3 FSC, 2 FC, 1 FE, 1 F) were used for method correlation between the new device and the predicate device.
- Precision Study: For within-run and within-device precision, 4 replicates of two retention time positional QC controls were run per day, across 20 days, on each of 3 separate systems, for a total of 160 runs per system (160 x 3 = 480 total measurements for each QC control in each peak category presented).
- Variant Peak Area Limit of Detection: 102 sample measurements.
- Data Provenance: Not explicitly stated, but given the context of a 510(k) submission for a device to be marketed in the US, it is an in-house study for regulatory purposes. The data is likely retrospective for the comparative correlation study as it compares against an existing predicate device using samples processed by both.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
- The document does not specify the number of experts or their qualifications used to establish ground truth for the test set. The correlation study relies on the predicate device's results as a reference, implying the predicate itself is the "truth" or was previously validated.
4. Adjudication Method (Test Set)
- The document does not describe a specific adjudication method. For the correlation study, the comparison is directly between the new device's identification and the predicate device's identification, noting "Agree" or "Disagree." Discrepancies (e.g., 1 FAS for FA, 1 FADC for FAD) are noted, but an adjudication process for these discrepancies is not detailed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This study focuses on validating the performance of an automated analytical instrument (HPLC system), not on human reader performance with or without AI assistance.
6. Standalone Performance Study
- Yes, a standalone performance study was conducted. The precision and variant peak area limit of detection studies specifically evaluate the performance of the new device (Bio-Rad VARIANT™nbs Sickle Cell Program) in isolation, establishing its intrinsic analytical capabilities. The correlation study also demonstrates the device's performance in identifying different hemoglobin types compared to a predicate method. Therefore, the presented data reflects the algorithm's (or device's) standalone performance.
7. Type of Ground Truth Used
- The ground truth for the correlation study is based on the results obtained from the predicate device (Bio-Rad VARIANT™ Sickle Cell Short Program, K924813).
- For the precision and variant peak area limit of detection studies, the ground truth is established by defined QC controls and samples used to determine analytical limits. Given the nature of a diagnostic device measuring specific biomarkers, the "ground truth" for individual samples would typically be derived from established reference methods or known concentrations/compositions of hemoglobin variants.
8. Sample Size for Training Set
- The document does not provide information regarding a specific "training set" or its sample size. This type of device (HPLC system) is not typically "trained" in the machine learning sense with a distinct training and test set as described for AI algorithms classifying images, for example. Its operational parameters and "pattern rules" are likely derived from scientific literature and established chemical and physical principles rather than statistical training on a large dataset in the way an AI model would be.
9. How Ground Truth for Training Set Was Established
- As noted above, the document does not describe a training set in the context of machine learning. The "pattern assignment" feature, which uses "pattern rules derived from literature," implies that the underlying logic for identifying hemoglobin peaks is based on established scientific knowledge and empirical data from previous research, rather than a separate training dataset with adjudicated ground truth in the current study.
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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)
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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 CellProgram | Predicate Device:Bio-Rad VARIANTTM Sickle Cell ShortProgram(K#924813) |
| Intended Use | The Bio-Rad VARIANTTMnbs Sickle CellProgram is intended as a qualitativescreen for the presence of hemoglobins F,A, S, D, C and E in eluates of neonatalblood collected on filter paper by highperformance liquid chromatography(HPLC). | The VARIANT Sickle Cell ShortProgram is designed as a qualitativescreen for the presence of hemoglobins F,A, S, D, C and E in eluates of neonatalblood collected on filter paper by highperformance 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 liquidchromatography. | Cation exchange high performance liquidchromatography. |
| Design - Assay Detection | Heme absorbance at 415 nm withbackground correction at 650 nm. | Heme absorbance at 415 nm withbackground correction at 650 nm. |
| Design - AnalytesIdentified | Six retention time windows forhemoglobins F, A, E, D, S and C. | Six retention time windows forhemoglobins F, A, E, D, S and C. |
| Design - Sample Type | Neonatal dried blood spots on filter papercollection cards. | Neonatal dried blood spots on filter papercollection cards. |
| Design - Punched Disc | One 1/8" disc. | One 1/8" disc. |
Comparison with Predicate Device
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| Summary of Technological Characteristic Similarities to Predicate Device | ||
|---|---|---|
| Features | New Device:Bio-Rad VARIANTTMnbs Sickle CellProgram | Predicate Device:Bio-Rad VARIANTTM Sickle Cell ShortProgram(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 TimeMarker 2 (FADC). | Elution Buffer 1. Elution Buffer 2.Wash Solution. Analytical Cartridge.Lyophilized Whole Blood Primer.Lyophilized Retention Time Marker 1(FAES). Lyophilized Retention TimeMarker 2 (FADC). |
| Performance -- Precision | Peak retention time precision is <1% forall hemoglobin peaks. | Peak retention time precision is <1% forall hemoglobin peaks. |
| Compatibility withEnvironment | U.S. FCC EMI and E.U. EMC standardcompliant. | U.S. FCC EMI and E.U. EMC standardcompliant. |
| Human Factors | For in vitro diagnostic use. Forprofessional use only. | For in vitro diagnostic use. Forprofessional use only. |
| Energy Used | Auto-switching 110 V and 220 V. | 110 V and 220 V models. |
| Chemical Safety | Sodium azide concentration <0.05%.Gentamicin Sulfate concentration <0.1%.Tobramycin concentration <0.1%.Warnings provided in labeling asrequired, including State of CaliforniaProposition 65 Warning. | Sodium azide concentration <0.05%.Gentamicin Sulfate concentration <0.1%.Tobramycin concentration <0.1%.Warnings provided in labeling asrequired, including State of CaliforniaProposition 65 Warning. |
| Electrical, Mechanical andThermal Safety | System certification to US and Canadianproduct safety standards and EU lowvoltage safety standards. | System certification to US and Canadianproduct safety standards and EU lowvoltage safety standards. |
| Standards Met | • EN375:2002• EN591:2001• EN980:2003• EN1658:1996• EN13485:2003• EN13640:2002• EN14971:2001• EN61010-1:2001• EN61010-2-101:2002• EN61326:2001 | • EN375:2002• EN591:2001• EN980:2003• EN1658:1996• EN13485:2003• EN13640:2002• EN14971:2001• EN61010-1:2001• EN61010-2-101:2002• EN61326:2001 |
| Summary of Technological Characteristic Differences in Comparison to Predicate Device | ||
|---|---|---|
| Features | New Device:Bio-Rad VARIANTTMnbs Sickle CellProgram | Predicate Device:Bio-Rad VARIANTTM Sickle Cell ShortProgram(K#924813) |
| Design - SystemConfiguration | Separate chromatography and autosampler modules and separate PCworkstation with software. | Single integrated unit withchromatography, auto sampler andsoftware functionalities. |
| Design - Media | CD-ROM. | ROM Card. |
| Summary of Technological Characteristic Differences in Comparison to Predicate Device | ||
| Features | New Device:Bio-Rad VARIANT™nbs Sickle CellProgram | Predicate Device:Bio-Rad VARIANT™ Sickle Cell ShortProgram(K#924813) |
| Design - Container, ElutionVolume, ReconstitutionVolume, Sample Loop,Column loading | Plastic 96 microwell plate. 250 µLsample elution volume. 500 µL primerand retention time marker reconstitutionvolume. 10 µL sample loop. Columnloading is 1/25 of eluted sample volumeand 1/50 of reconstituted material. | Plastic sample vial. 500 µL sampleelution volume. 1000 µL primer andretention time marker reconstitutionvolume. 20 µL sample loop. Columnloading is 1/25 of eluted sample volumeand 1/50 of reconstituted material. |
| Design - Aspiration ProbeTip, Punched DiscDisposition | Beveled aspiration probe tip. Dried bloodspot punched disc left in microwell duringsample aspiration. | Blunt aspiration probe tip. Dried bloodspot punched disc removed before sampleaspiration. |
| Design - Additionalretention time windows. | Seven (7) additional retention timewindows: F1, "Other (1)", "Other (2)","Other (3)", "Other (4)", "Other (5)" and"Other (6)". | Feature not available. |
| Design - AutomatedWorklists | Accepts automated worklists from spotpunchers. | Feature not available. |
| Design - Pattern Assignment | Optional pattern assignment feature usespattern rules derived from literature. | Feature not available. |
| Performance - VariantsLimit of Detection | The limit of detection for S, D, C and E is1% of the total area of the sample whenthe total area is 1.5 millionmicrovolt·second. | Limit of detection for hemoglobins S, D,C and E is 1% of the total area when thetotal area of the sample is 1.0 millionmicrovolt second. |
| Performance -- Guideline forInterpretation of Results | Total area must be between 900,000 to6.3 million microvolt second. | Total area should range from 1,000,000-3,000,000 microvolt·second. |
| Performance - Total AreaLimit of Detection | 900,000 microvolt·second. | Not addressed in instruction manual. |
| Performance -- Bilirubininterference | Bilirubin up to 20 mg/dL does notinterfere. | Not addressed in instruction manual. |
| Performance - Triglycerideinterference | Triglyceride up to 6000 mg/dL does notinterfere. | Not addressed in instruction manual. |
| Performance - Eluatestability | Eluates are stable for 48 hrs on the cooledauto sampler and at 2-8 °C and stable for24 hrs at 15-30 °C. | Eluates are stable for 24 hrs at 2-8 °C. |
| Guidances Met | • FDA 2002 - General Principles ofSoftware Validation; Final Guidancefor Industry and FDA Staff.• FDA 1999 - Guidance for Off-the-Shelf Software Use in MedicalDevices; Final.• FDA 1998 - Guidance for the Contentof Premarket Submissions forSoftware Contained in MedicalDevices; Final.• FDA 2003 - Device Advice; Contentof a 510(k) | Not addressed. |
| Standards Met | • NCCLS EP-05A 1999.• NCCLS EP-05A2 2004. | Not addressed. |
Bio-Rad Laboratories, Inc. Bio-Rad Laser Program Sickle Cell Program 510(k) (Revision: April 11, 2005)
7
7
{4}------------------------------------------------
{5}------------------------------------------------
Testing to Establish Equivalence
Correlation .
Method correlation between predicate device and Bio-Rad VARIANT™nbs Sickle Cell Program new Metinon correlation octwoon progress prepared from neonatal dried blood spot collection cards. The results are presented in the following table:
| Number of | Predicate Device | New device | |
|---|---|---|---|
| Samples | F, A, E, D, S and (or) C Identified | 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 VARIANT™hbs 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 was 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 withindevice precision (formerly total precision) were determined. The reported predicate device retention time precision protocol included the same two retention time positional QC controls, however, the nrotocol did not conform to NCCLS Protocol EP5-A2 guidelines nor was with-in laboratory (or withindevice) precision reported. The results are presented in the following tables:
| Retention Time With-in Run Precision Summary | ||||||||
|---|---|---|---|---|---|---|---|---|
| Retention Time Within-Run Precision (CV %) | ||||||||
| Device | Replicates | Sample | Peak F | Peak A | Peak E | Peak D | Peak S | Peak C |
| New | 160 x 3 | QC Control 1 | 0.3-0.5 | 0.3-0.4 | 0.3-0.4 | 0.2-0.3 | ||
| Predicate | 10 x 1 | QC Control 1 | 0.7 | 0.0 | 0.0 | 0.0 | ||
| New | 160 x 3 | QC Control 2 | 0.3-0.5 | 0.3-0.4 | 0.2-0.3 | 0.1-0.3 | ||
| Predicate | 10 x 1 | QC Control 2 | 0.6 | 0.0 | 0.4 | 0.3 |
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| Retention Time With-in Device Precision (Formerly Total Precision) | ||||||||
|---|---|---|---|---|---|---|---|---|
| Retention Time Within-Device Precision (CV %) | ||||||||
| Device | Replicates | Sample | Peak F | Peak A | Peak E | Peak D | Peak S | Peak C |
| New | 160 x 3 | QC Control 1 | 0.3-0.6 | 0.4-0.6 | 0.4-0.6 | 0.5-0.6 | ||
| Predicate | Not reported | |||||||
| New | 160 x 3 | QC Control 2 | 0.3-0.7 | 0.4-0.6 | 0.4-0.5 | 0.2-0.3 | ||
| Predicate | Not reported. |
Variant Peak Area Limit of Detection
The Bio-Rad VARIANT™hbs 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 nomic count variants (2) = = = = imit of detection for each variant 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. The results are presented in the following table:
| Variant Peak Area Limit of Detection | |||||
|---|---|---|---|---|---|
| Device | ChromatogramTotal 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% |
Conclusions
The similarities of the intended use and the general performance characteristics and results of the newly described and evaluated Bio-Rad VARIANT™nbs Sickle Cell Program new device used with the Bio-Rad VARIANT™nbs Newborn Screening System with Bio-Rad Genetic Data Management Software for the VARIANT™nbs Newborn Screening System are nearly identical to logical extensions of those for the cleared predicate device and associated system. Thus, one may conclude based on the new device system use of the same HPLC technology, and the nearly equivalent results obtained from the correlation, precision and variant peak area limit of detection versus the corresponding results obtained with the predicate device system that the new Bio-Rad VARIANT™nbs Sickle Cell Program system is substantially equivalent to the cleared and currently marketed predicate device system.
{7}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle.
MAY 1 2 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Bio-Rad Laboratories c/o Dr. Alfredo J. Quattrone California Department of Health Services (CA-DHS) Food and Drug Branch, MS-7602 1500 Capitol Avenue Sacramento, CA 95814
K051072 Re: Trade/Device Name: Bio-Rad VARIANT™ nbs Sickle Cell Program Regulation Number: 21 CFR 864.7415 Regulation Name: Abnormal hemoglobin assay Regulatory Class: Class II Product Code: GKA Dated: April 19, 2005 Received: April 26, 2005
Dear Dr. Quattrone:
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 for associated in the 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 r hat 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 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 proceed to the market.
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Page 2 -
If you desire specific information about the application of labeling requirements to your device, r fou dens on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I ou may oouan bana getirers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Robert Beckerh
Robert L. Becker, Jr., MD, PH.D Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Sec. D - 510(k) Statement of Indications for Use
Statement of Indications for Use
510(k) Number if Known:
Device Name:
Indications for Use:
Bio-Rad VARIANT™nbs Sickle Cell Program
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.
Prescription Use __
(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
Office of In Vitro Diagnostic Device Evaluation and Safety
051072 510(k).
Bio-Rad Laboratories, Inc. Bio-Rad VARIANTnbs Sickle Celi Program 510(k) Page 1 of 1
(Revision: April 11, 2005)
Page D-1
§ 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.