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BK110002 Summary

510(K) Summary

The assigned 510(k) number: BK110002

Submitted by
Gen-Probe Transplant Diagnostics, Inc.
550 West Avenue
Stamford, CT 06902
Phone: (203) 328-9523
Fax: (203) 328-9599
Contact Person: Susan Leary

Summary Prepared on December 2, 2011

Trade Name:LIFECODES HLA-A eRES Typing Kit for use with Luminex
LIFECODES HLA-B eRES Typing Kit for use with Luminex
LIFECODES HLA-DRB1 eRES Typing Kit for use with Luminex
LIFECODES HLA-DRB 3,4,5 Typing Kit for use with Luminex

Common Name: HLA-SSO Typing Kits
Classification Name: Qualitative test for HLA, non-diagnostic (Product code MZI) 

Predicate Device
510(k) Number: BK080050 and BK050003
Common Name: HLA-SSO Typing Kits

Trade Name:LIFECODES HLA-A Typing Kit for use with Luminex
LIFECODES HLA-B Typing Kit for use with Luminex
LIFECODES HLA-C Typing Kit for use with Luminex
LIFECODES HLA-DQB Typing Kit for use with Luminex
LIFECODES HLA-DRB Typing Kit for use with Luminex
LIFECODES HLA-DRB1 Typing Kits for use with Luminex

Description of the Device
The LIFECODES HLA-SSO Typing Kits are used to determine an individual’s HLA type.  The kits utilize sequence-specific oligonucleotides (SSOs), bound to microspheres (with unique fluorescent signatures), to identify the HLA alleles present in DNA samples.  The device family consists of ten kits for typing the HLA-A, HLA-B, HLA-C, HLA-DQB and HLA-DRB Loci.

DNA-based HLA-Typing using PCR amplified DNA is a common laboratory procedure.  PCR amplification of DNA is used as the means to enrich for a selected DNA region.  For HLA typing, a subsequent assay is utilized to determine the properties of amplified DNA.  Several types of assays, such as SSP, direct SSOP, RFLP and reverse SSOP dot blot technologies, have been used in HLA typing.  LIFECODES HLA-SSO Typing kits utilize sequence-specific oligonucleotides (SSOs) to identify which HLA alleles are present in a PCR amplified sample.

Summary of Substantial Equivalence
Performance:
When LIFECODES HLA SSO Typing Kits are used according to the procedure described in the product insert, the Class I and Class II HLA type of DNA samples can be determined.  The HLA A eRES Kit shows 98.46% agreement (95.24% lower boundary of 95% Confidence Interval) and the  HLA B eRES, DRB1 eRES and DRB 3,4,5 Kits show 100% agreement (97.72% lower boundary of 95% confidence interval)  for 130 samples evaluated when compared to results obtained with bi-directional sequencing.  
Stability / Shelf life
Stability data supports the current shelf life of at least two years.

Intended Use: DNA typing of Class I and Class II HLA Alleles