SeCore CDx HLA Sequencing System
Device Facts
| Record ID | BK261357 |
|---|---|
| Device Name | SeCore CDx HLA Sequencing System |
| Applicant | One Lambda, Inc. West Hills, CA 91304 |
| Product Code | QUK · Immunology |
| Decision Date | Jun 17, 2026 |
| Decision | SESE |
| Regulation | 21 CFR 866.5960 |
| Device Class | Class 2 |
Indications for Use
The SeCore CDx HLA Sequencing System is intended for the detection of human leukocyte antigen A-locus (HLA-A) alleles using genomic DNA isolated from whole blood samples. The device is intended to be used as a companion diagnostic (CDx) to aid in the selection of patients who may benefit from treatment or are likely to be at increased risk for serious adverse reactions because of treatment with therapies listed in the table below when used in accordance with approved therapeutic labeling. Indication(s): Unresectable or Metastatic Uveal Melanoma; HLA Target Allele(s): Eligible allele: HLA-A*02:01; Therapy: KIMMTRAK® (tebentafusp-tebn). Indication(s): Unresectable or Metastatic Synovial Sarcoma in Patients who have Received Prior Chemotherapy; HLA Target Allele(s): Eligible alleles: HLA-A*02:01, HLA-A*02:02, HLA-A*02:03 or HLA-A*02:06 and their P-group alleles Exclusion alleles: HLA-A*02:05 and its P-group alleles; Therapy: TECELRA® (afamitresgene autoleucel).
Device Story
System performs sequence-based typing (SBT) of HLA-A alleles from genomic DNA purified from whole blood. Process: PCR amplification of target HLA genes using SeCore primers; Sanger sequencing of amplified products; analysis of resulting data files via uTYPE CDx HLA Sequence Analysis Software. Software compares sample sequences against IPD-IMGT/HLA database for allele assignment. Used in clinical laboratory settings by trained personnel. Output provides HLA-A allele identification to assist clinicians in selecting patients for specific therapies (KIMMTRAK or TECELRA) based on companion diagnostic requirements. Benefits include identifying patients likely to benefit from targeted immunotherapy or at risk for adverse reactions.
Clinical Evidence
Clinical equivalence evaluated across three sites (N=299) comparing SeCore Sequencing System to predicate (SSP UniTray). Additional clinical trial data (IMCgp100-202 and ADP-0044-002) supported companion diagnostic utility for HLA-A allele detection in target patient populations. Analytical performance established via accuracy, precision, reproducibility, stability, and interference studies.
Technological Characteristics
Sequence-based typing (SBT) system. Components: Veriti™ Dx 96-Well Thermal Cycler (PCR), Applied Biosystems 3500 Dx/3500 xL Dx Genetic Analyzer (capillary electrophoresis). Detection: Fluorescent emission via BigDye™ Terminators. Software: uTYPE CDx HLA Sequence Analysis Software running on Windows 10 PC. Analyzes genomic DNA from whole blood.
Indications for Use
Indicated for patients with unresectable or metastatic uveal melanoma (HLA-A*02:01 positive) and patients with unresectable or metastatic synovial sarcoma who have received prior chemotherapy (HLA-A*02:01, *02:02, *02:03, or *02:06 positive; excluding HLA-A*02:05).
Regulatory Classification
Identification
A human leukocyte antigen (HLA) typing companion diagnostic (CDx) test is a prescription genotyping or phenotyping in vitro diagnostic product intended for use as an aid in identifying patients who have specific HLA allele(s) or express specific HLA antigen(s) and may benefit from treatment with a corresponding therapeutic product or are likely to be at increased risk for serious adverse reactions as a result of treatment with a corresponding therapeutic product.
Special Controls
*Classification.* Class II (special controls). The special controls for this device are:(1) The intended use of the device must specify the target HLA allele(s) or antigen(s), the patient population(s), and the corresponding therapeutic product(s). (2) Design verification and validation must include: (i) Detailed documentation of an analytical accuracy study that uses well-characterized samples including clinical samples from intended use population(s) focusing on the target allele(s) needed for patient selection; (ii) Detailed documentation of precision studies (repeatability, reproducibility) that evaluate possible sources of variation that may affect test results; (iii) Detailed documentation of a study determining range of input sample concentrations that meet performance specifications; (iv) Detailed description of the ambiguity resolution method, if applicable; (v) For a sequencing-based assay, documentation of coverage and predefined coverage threshold of target genomic regions, pertinent variant types, and sequence contexts; (vi) For multiplex assays, documentation of a risk assessment and design specifications that are in place to prevent incorrect reactivity assignment; (vii) Description of a plan on how to ensure the performance of the device does not change when new HLA alleles are identified, and/or when reactivity assignments are changed; and (viii) Detailed description of device software including standalone software, or software and bioinformatics analysis pipeline, if applicable, incorporated in the instruments, and documentation of software including the level of concern and associated risks, software requirement specifications, software design specifications ( *e.g.,* algorithms, alarms and device limitations), hazard analysis, traceability matrix, verification and validation testing, unresolved anomalies, hardware requirements, and effective cybersecurity management.(3) Clinical validity data (which may include summary reports from clinical trials, comparison studies using clinical samples, or through an alternative approach determined to be appropriate by FDA), demonstrating the following, as applicable: (i) Which patients identified by the HLA CDx test are most likely to benefit from the corresponding therapeutic product; and (ii) Which patients identified by the HLA CDx test are likely to be at increased risk for serious adverse reactions as a result of treatment with the corresponding therapeutic product. (4) If the HLA test used in the clinical trials is different from the HLA CDx test in the premarket notification submission, the submission must include results of a bridging study, or an alternative approach determined to be appropriate by FDA.
Predicate Devices
- SeCore™ CDx HLA Sequencing System (BR220737, BK241074)
Reference Devices
- SSP UniTray with UniMatch Plus interpretation software
- Applied Biosystems 3500 Dx /3500 xL Dx Genetic Analyzer (BK110039)
