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BK130075 Summary

LIFECODES HLA SSO Typing Kits for use with Luminex

Summary  Prepared : November 25, 2013

1. Device Owner:
Address:
Phone:
Fax:
Immucor Transplant Diagnostics, Inc.
550 West Avenue, Stamford, CT 06902, USA
203-328-9500
203-328-9599
     
  Submitter/Manufacturer:
Address:
Phone:
Fax:
Name of Submitter:
Immucor Transplant Diagnostics, Inc.
550 West Avenue, Stamford, CT 06902, USA
203-328-9500
203-328-9599
Lorraine Calzetta

Device Trade Name:         
LIFECODES® HLA SSO Typing Kits for use with Luminex  

LIFECODES HLA-A SSO Typing Kit for use with Luminex
LIFECODES HLA-A eRES  SSO Typing Kit for use with Luminex
LIFECODES HLA-B SSO Typing Kit for use with Luminex
LIFECODES HLA-B eRES SSO Typing Kit for use with Luminex
LIFECODES HLA-C eRES SSO Typing Kit for use with Luminex
LIFECODES HLA-DQB SSO Typing Kit for use with Luminex
LIFECODES HLA-DRB1 SSO Typing Kit for use with Luminex
LIFECODES HLA-DRB1 eRES SSO Typing Kit for use with Luminex
LIFECODES HLA-DRB 3, 4, 5 SSO Typing Kit for use with Luminex

Common Name:
HLA SSO Typing Kit

Division:
Review Panel:
Product Code:
Classification:
Submission Type:
Device Class:
CBER
Hematology
MZI
Unclassified
510(k)
2

 

  1. Name of Predicate Device for Claiming Equivalence
    LIFECODES HLA SSO Typing Kits for use with Luminex (BK050003, BK080050, BK110002, BK120063)
    LIFECODES HLA-A Typing Kit for use with Luminex
    LIFECODES HLA-A eRES Typing Kit for use with Luminex
    LIFECODES HLA-B Typing Kit for use with Luminex
    LIFECODES HLA-B eRES Typing Kit for use with Luminex
    LIFECODES HLA-C eRES Typing Kit for use with Luminex
    LIFECODES HLA-DQB Typing Kit for use with Luminex
    LIFECODES HLA-DRB1 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

     

  2. Description of Device

    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. This special 510(k) submission proposes the changes to the procedure for performing the assay. The submission proposes a shortened time for amplification and hybridization and reduced volume for amplification.

    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. The kits are designed to be used with the Luminex Instrument.
    The Luminex instrument has been previously cleared by FDA   (K073506).

     

  3. Intended Use
    There are no changes to the Intended Use between the currently cleared LIFECODES HLA SSO Typing Kits device and the modified LIFECODES HLA SSO TYPING kits

    Intended Use:

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

     

  4. Support of substantial equivalence based on comparison of features, characteristics and components to the predicate device:

    There are no changes to the design of the device pursuant to this submission. This submission proposes a modification to the assay procedure to yield a shortened protocol.   The amplification (PCR reaction) volume has also been reduced.

    Summary of similarities and differences between Predicate and Modified Device -HLA SSO Typing Kits:

    The modified LIFECODES HLA SSO Typing Kits are similar to the LIFECODES HLA Typing Kits (predicate device) in the following:
    1. LIFECODES HLA SSO Typing Kits have the same intended use and indications for use compared to the predicate devices.
    2. LIFECODES HLA SSO Typing Kits utilize the same technology (PCR and bead based Luminex immunoassay) and assay steps as the predicate devices.
    3. LIFECODES HLASSO Typing Kits utilize the same assay components as the predicate device. There are no changes to manufacturing, packaging or packaging configuration.
    4. LIFECODES HLA SSO Typing Kits uses the same sample types and same procedures for sample preparation as the predicate devices.

      The modified LIFECODES HLA Typing Kits differs from the predicate device in the following:
Procedure Time.
Predicate HLA SSO Typing kits   Modified  HLA  SSO Typing kits
2 hours and 30 minutes Amplification Protocol 1 hour and 12 minutes
45 minutes Hybridization Protocol 20 minutes
3 hours and 15 minutes Total Assay Time 1 hours and 32 minutes
50uL PCR Reaction Volume 20uL
100-300ng
(2-6ng/uL of PCR)
Analytical Sensitivity 40-120ng
(2-6ng/uL of PCR)

Performance:
No performance changes are claimed for the modified procedure.

Accuracy

Accuracy studies were  performed  using  a panel of one hundred and thirty samples, which includes a combination of well characterized UCLA reference samples and bi-directionally sequenced samples. The analysis was performed using the exact method (Clopper-Pearson) to calculate the one sided 95% confidence interval for the prcentage of concordance.

All kits showed 100% (97.72% lower bound one-sided 95% confidence) concordance when testing reference samples as compared to the predicate.

Stability / Shelf life

The LIFECODES HLA SSO Typing kits have a two year shelf life. There is no change from the predicate.

Reproducibility Results using LIFECODES Typing Kit showed 98% within lot repeatability (5 runs/5 days) and 99.8% lot to lot reproducibility. (Three operators) (3 lots). This is substantially equivalent to the predicate

Analytical sensitivity

Due to the change in volume in the assay, the amount of DNA required has been modified from 100ng genomic DNA lower limit to 40ng genomic DNA. The concentration of DNA remains the same. The modified device was shown to perform substantially equivalent to the predicate at 20-180ng genomic DNA.

External Site Validation of User Needs

44 reference clinical samples were tested at each of 4 external sites and all performance specifications and user needs were met.

  1.  Conclusion:

Based on comparison with the predicate device, LIFECODES HLA SSO Typing Kits, the modified HLA SSO Typing Kits are substantially equivalent to the predicate devices and do not present new issues of safety and effectiveness.