Review Memo and SE Recommendation for BK020032
| Date: |
March 17, 2003 |
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| To: |
File BK020032
Device: NGTL Automation System (NAS)
Sponsor: American Red Cross Blood Services
Contact: Stephen Kassapian, Director, Regulatory Affairs |
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| From: |
Linda Weir, Software Reviewer, Devices Review Branch |
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| Subject: |
Review memo and SE recommendation for BK020032, NAS |
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| CC: |
Sheryl A. Kochman, Chief, DRB
Nadine Brock, Software Reviewer, DRB
Diane Gubernot, Software Reviewer, DETTD
Barbara Sanchez, Software Reviewer, DETTD |
I reviewed the August 13, 2002 submission for National Genome Testing Lab (NGTL) Automation System (NAS), version 5.2.0, BK020032. The submission was a traditional 510(k). It consisted of two volumes. This software device has been used by ARC for
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Intended Use:
The intended use is stated to be data management software that is not intended to perform any interpretations of test results, but rather to assemble and correlate automated and/or manual test results by unique identification number from blood samples. NAS blood testing information can include information pertinent to collections, sample/pool tracking, results management, administration, reporting, and test process turnaround statistics.
Hardware and Software Platform:
NAS is based on client server architecture. The NAS servers include the application server components that are used at the National Headquarters Data Center and the Disaster Recovery Data Center. NAS applications run on IBM RISC System 6000 servers connected to an EMC2 disk storage array running the AIX 4.3.2 operating system. User sites of NAS operating on Windows 95 and Windows NT are connected via their Local Area Networks (LAN's) to a Wide Area Network (WAN). The end user devices are PC workstations. Several manufacturers meet ARC desktop requirements. Standard PC desktop requirements are:
- Hardware: INTEL 133 MHz Pentium, 4 GB hard drive, CD ROM, VGA color monitor and board, network card, mouse and keyboard
- Random Access Memory (RAM): 128 MB
Predicate Device:
The predicate device is Information Data Management (IDM) Surround System 2.0, BK000016.
Level of Concern:
This device is a major level of concern in that it is an accessory to the Gen-Probe NAT instrument. As an accessory to a device it is regulated to the same level as the parent device.
Review Documentation-Additional Information requested from the sponsor:
Review of the August 9, 2002 submission required additional information from the sponsor before a recommendation could be made. The sponsor provided the additional information in a February 7, 2003 response. FDA had a telecon with ARC on March 7, 2003 requesting clarification of their response. This information was provided in faxes received March 7 -12, 2003. The firm will follow-up with hardcopies.
Recommendation:
I recommend a determination of substantial equivalence be made.
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