Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software

K171664 · Bio-Rad Laboratories, Inc. · GKA · Sep 13, 2017 · Hematology

Device Facts

• Record ID: K171664
• Device Name: Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software
• Applicant: Bio-Rad Laboratories, Inc.
• Product Code: GKA · Hematology
• Decision Date: Sep 13, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.7415
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

Indications for Use

The intended use of the modified device as described in its labeling has not changed.

Device Story

The Hemoglobin Variants System is a fully automated, high-throughput HPLC analyzer for neonatal dried blood spot screening. The system uses the Newborn Hemoglobin System (NHS) instrument, comprising a Newborn Chromatographic Station (NCS) and Newborn Auto Sampler (NAS). Punched blood spot discs are eluted in water and injected into a cation exchange gel mini-column. A pre-programmed phosphate buffer gradient separates hemoglobins over three minutes; a dual-wavelength photometer (415 nm and 690 nm) detects eluates. Genetic Disease Management (GDM) software controls the assay, processes HPLC data, and assigns presumptive phenotypes based on retention time windows and rule-based pattern matching. HbReview software facilitates remote data transmission from screening sites to a central server, allowing authorized reviewers to examine results, add comments, and release reports. The system assists clinicians in identifying hemoglobinopathies, enabling timely follow-up for neonates.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by technological characteristics and performance comparisons to the predicate device.

Technological Characteristics

In vitro diagnostic system for hemoglobin variant screening. Software-based modification (HbReview Software) added to existing GDM (Genetic Disease Management) software platform. Connectivity via data transmission from GDM to central site. Software risk management per ISO 14971.

Indications for Use

Indicated for professional laboratory IVD use to isolate and identify inherently determined abnormal (S, D, C, E) and normal (F, A) hemoglobin types in neonatal blood samples.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• VARIANT™ nbs Sickle Cell Program (K080911)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification OIR Decision Summary

To: THE FILE

RE: DOCUMENT NUMBER K171664

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary):

1. The name and 510(k) number of the SUBMITTER'S previously cleared device: VARIANT™ nbs Sickle Cell Program, K080911.
2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for a the addition of HbReview Software and a product name change from VARIANT™ nbs Sickle Cell Program to Hemoglobin Variants System on Newborn Screening System with GDM and HbReview Software.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including: labeling, intended use, physical characteristics, and assay methods. The only difference between the subject device and predicate is the addition of the HbReview Software which offers central site result collection and review capabilities for results transmitted from the GDM (Genetic Disease Management) software. When compared to the predicate device labeling, the modified device includes instructions for transmitting run data using the Genetic Data Management (GDM) 3.1.5 Software for the Newborn Hemoglobin System™ (NHS), and an additional instruction manual for the HbReview Software that describes functionality, usability and interface requirements and limitations.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis. Risk Analysis was performed following Risk Management Procedure; SOP 2013. Software updates were reviewed using Failure Mode Effects Analysis to identify potential risks (Appendix A), ISO 14971 and FDA guidance for the Content of Premarket Submission for Software Contained in Medical Devices. A high level risk analysis and a detailed software risk analysis with mitigation information were provided in the Verification and Validation Report and Software Hazard Analysis Report (Appendix A). In conclusion, no patient or safety risks are introduced.

b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria was applied and found to be satisfactory. No safety risks were introduced. Descriptions of the verification and validation activities were provided for the Hemoglobin Variants System. System level test protocols, including pass/fail criteria, and test results for newborn screening hemoglobin assays were also provided.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified

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devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.