← Product Code [QUK](/productcode/QUK) · BK261357 # SeCore CDx HLA Sequencing System (BK261357) _One Lambda, Inc. West Hills, CA 91304 · QUK · Jun 17, 2026 · Immunology · SESE_ **Canonical URL:** https://fda.innolitics.com/device/BK261357 ## Device Facts - **Applicant:** One Lambda, Inc. West Hills, CA 91304 - **Product Code:** [QUK](/productcode/QUK.md) - **Decision Date:** Jun 17, 2026 - **Decision:** SESE - **Regulation:** 21 CFR 866.5960 - **Device Class:** Class 2 - **Review Panel:** Immunology ## 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. ## Regulatory 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](/device/BK241074.md)) ## Reference Devices - SSP UniTray with UniMatch Plus interpretation software - Applied Biosystems 3500 Dx /3500 xL Dx Genetic Analyzer ([BK110039](/device/BK110039.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} Individuals using assistive technology may not be able to fully access the information contained in this file. For assistance, please call 800-835-4709 or 240-402-8010, extension 1. CBER Consumer Affairs Branch or send an e-mail to: ocod@fda.hhs.gov and include 508 Accommodation and the title of the document in the subject line of your e-mail. {1} **ThermoFisher** SCIENTIFIC The world leader in serving science SeCore CDx HLA Sequencing System Special 510(k) ONE LAMBDA A Thermo Fisher Scientific Brand ## 510(k) SUMMARY This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92. **1. Submission Type:** Special 510(k) **2. Date Prepared:** May 18, 2026 # **3. Submitter Information** Owner One Lambda, Inc. 22801 Roscoe Blvd West Hills, CA 91304 Contact(s) Primary: Sheryl Skinner Title: Director, Regulatory and Clinical Affairs Address: One Lambda, Inc. 22801 Roscoe Boulevard West Hills, CA 91304 USA Tel: (b) (6) Email: sheryl.skinner@thermofisher.com Alternate: Angela Estany Title: Sr. Director, Regulatory Affairs and Quality Address: One Lambda, Inc. 22801 Roscoe Boulevard West Hills, CA 91304 USA Tel: (b) (6) Email: angela.estany@thermofisher.com Page 1 of 6 {2} ThermoFisher SCIENTIFIC The world leader in serving science SeCore CDx HLA Sequencing System Special 510(k) #### 4. Device Information | Product Code | Device Classification Name | Device Name | Submission Type/Number | Regulation Number | Class | Panel | | --- | --- | --- | --- | --- | --- | --- | | QUK | Human Leukocyte Antigen (Hla) Typing Companion Diagnostic Test | SeCore™ CDx HLA Sequencing System | Special 510(k)/ Pending | 866.5960 | II | Immunology | #### 5. Predicate Device: | Product Code | Device Classification Name | Device Name | Submission Type/Number | Regulation Number | Class | Panel | | --- | --- | --- | --- | --- | --- | --- | | QUK | Human Leukocyte Antigen (Hla) Typing Companion Diagnostic Test | SeCore™ CDx HLA Sequencing System | Direct De Novo / Traditional 510(k) (BR220737, BK241074) | 866.5960 | II | Immunology | #### 6. Device Description The SeCore CDx HLA Sequencing System uses a sequence-based typing (SBT) method to detect HLA-A alleles in genomic DNA purified from whole blood specimens. SeCore CDx HLA Sequencing Kits directly identify the DNA sequence of target HLA genes. Polymerase chain reaction (PCR) is used with SeCore primers to perform locus-specific DNA amplification. Sanger sequencing is then used to determine the nucleotide sequence of the amplified product. Resulting data files are analyzed with uTYPE CDx HLA Sequence Analysis Software, which compares sample sequences to reference sequences in the IPD-IMGT/HLA database for HLA allele assignment. #### 7. Intended Use and Indications for Use Statement 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. Page 2 of 6 {3} ThermoFisher SCIENTIFIC The world leader in serving science SeCore CDx HLA Sequencing System Special 510(k) 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. Table 1: Proposed Indications for Use | Indication(s) | HLA Target Allele(s) | Therapy | | --- | --- | --- | | Unresectable or Metastatic Uveal Melanoma | Eligible allele: HLA-A*02:01 | KIMMTRAK® (tebentafusp-tebn) | | Unresectable or Metastatic Synovial Sarcoma in Patients who have Received Prior Chemotherapy | 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 | TECELRA® (afamitresgene autoleucel) | ### 8. Nonclinical Studies The SeCore CDx HLA Sequencing System has well established analytical performance characteristics from analytical studies conducted for 510(k)-clearance (refer to BK110038). - Accuracy - Precision, Reproducibility - Stability - Shipping/Transportation - Detection Limit - Sample Preparation - Assay Cut-off - Interference Testing Two additional studies have been completed to support the SeCore CDx HLA Sequencing System for use as a companion diagnostic to ensure that the device is accurate within the target population and can effectively discriminate the required target allele(s). - Detection of HLA-A*02:01 (KIMMTRAK®) Page 3 of 6 {4} **ThermoFisher** SCIENTIFIC The world leader in serving science SeCore CDx HLA Sequencing System Special 510(k) - Detection of HLA-A*02:01, HLA-A*02:02, HLA-A*02:03 or HLA-A*02:06 and their P-group alleles, excluding HLA-A*02:05 and its P-group alleles (TECELRA®) All test results demonstrated that subject device meets the requirements of its pre-defined acceptance criteria and intended use. ### 9. Clinical Testing Samples from three testing sites (N=299) were tested to evaluate the equivalence between the SeCore Sequencing System and a predicate device (SSP UniTray with UniMatch Plus interpretation software). Test results demonstrated that subject device meets the requirements of its pre-defined acceptance criteria. Additional companion diagnostic clinical trial studies were conducted using the SeCore CDx HLA Sequencing System for detection of human leukocyte antigen A-locus (HLA-A) alleles to aid in the selection of patients who may benefit from treatment with associated therapies. (Refer to Study Trials, IMCgp100-202 and ADP-0044-002) ### 10. Substantial Equivalence Determination The device that is subject of the premarket notification submission has the same technological characteristics as the predicate device, the De Novo granted device previously cleared by FDA on November 28, 2022 (see BR220737) and Traditional 510(k) cleared on August 1, 2024. A summary of the technological characteristics is as follows: **Table 5: Comparison with Proposed Predicate Device** | | Predicate Device (BR220737, BK241074) | New Device (BK# Pending) | | --- | --- | --- | | **Device Name** | SeCore™ CDx HLA Sequencing System | Same | | **Submission Number** | BR220737, BK241074 | Pending | Page 4 of 6 {5} **ThermoFisher** SCIENTIFIC The world leader in serving science SeCore CDx HLA Sequencing System Special 510(k) | | Predicate Device (BR220737, BK241074) | | | New Device (BK# Pending) | | --- | --- | --- | --- | --- | | **Regulation Number** | 21 CFR 866.5960 | | | Same | | **Regulation Name** | Human leukocyte antigen typing companion diagnostic test | | | Same | | **Classification** | Class II | | | Same | | **Product Code** | QUK | | | Same | | **Intended 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: | | | Same | | | **Indication(s)** | **HLA Target Allele(s)** | **Therapy** | | | | Unresectable or metastatic Uveal Melanoma | Eligible allele: HLA-A*02:01 | KIMMTRAK® (tebentafusp-tebn) | | | | Unresectable or Metastatic Synovial Sarcoma in Patients who have Received Prior Chemotherapy | 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 | TECELRA® (afamitresgene autoleucel) | | | **Indications for Use** | For use in the unresectable or metastatic uveal melanoma and the unresectable or metastatic synovial sarcoma patient populations. | | | Same | Page 5 of 6 {6} ThermoFisher SCIENTIFIC The world leader in serving science SeCore CDx HLA Sequencing System Special 510(k) | | Predicate Device (BR220737, BK241074) | New Device (BK# Pending) | | --- | --- | --- | | Assay Method | Sequence Based Typing | Same | | Reactive Ingredient | Genomic DNA | Same | | Specimen Type(s) | Whole Blood | Same | | Sample Type(s) | Purified DNA | Same | | Detection Reagents | Fluorescent emission detection from BigDye™ Terminators | Same | | Software Technology | Uses personal computer. Operates with a Windows 10 operating system | Same | | Software Main Components | uTYPE CDx HLA Sequence Analysis Software | Same | | Instrumentation | DNA Amplification: Veriti™ Dx 96-Well Thermal Cycler Model 9912 with 0.2-mL sample wells (Class I Device) Capillary electrophoresis: Applied Biosystems 3500 Dx /3500 xL Dx Genetic Analyzer CS2 (Class 2 Device, 510(k)-cleared BK110039) | Same | ### 11. Conclusion Analysis of the non-clinical, clinical, and safety and performance data concludes that the subject device SeCore CDx HLA Sequencing System is equivalent to the predicate device. Page 6 of 6 --- **Source:** [https://fda.innolitics.com/device/BK261357](https://fda.innolitics.com/device/BK261357) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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