SeCore CDx HLA Sequencing System

BK241074 · One Lambda, Inc. West Hills, CA · QUK · Aug 1, 2024 · Immunology

Device Facts

• Record ID: BK241074
• Device Name: SeCore CDx HLA Sequencing System
• Applicant: One Lambda, Inc. West Hills, CA
• Product Code: QUK · Immunology
• Decision Date: Aug 1, 2024
• Decision: SESE
• Regulation: 21 CFR 866.5960
• Device Class: Class 2
• Attributes: Software as a Medical Device

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 uses sequence-based typing (SBT) to detect HLA-A alleles in genomic DNA from whole blood; utilizes PCR for locus-specific amplification followed by Sanger sequencing; fluorescent emission detection via BigDye Terminators. Data analyzed by uTYPE CDx HLA Sequence Analysis Software; compares sample sequences to IPD-IMGT/HLA database for allele assignment. Used in clinical laboratory settings; operated by trained laboratory personnel. Output provides HLA-A allele status to clinicians to aid in patient selection for specific therapies (KIMMTRAK or TECELRA). Benefits include identifying patients likely to benefit from or at risk of adverse reactions to targeted therapies.

Clinical Evidence

Clinical equivalence evaluated using 299 samples across three sites comparing SeCore Sequencing System to SSP UniTray/UniMatch Plus. Additional clinical trial data (IMCgp100-202 and ADP-0044-002) supported the companion diagnostic utility for patient selection. Analytical performance established via accuracy, precision, reproducibility, stability, and interference testing.

Technological Characteristics

Sequence-based typing (SBT) assay; genomic DNA input; PCR amplification; Sanger sequencing; fluorescent emission detection. Instrumentation includes Veriti™ Dx 96-Well Thermal Cycler and Applied Biosystems 3500 Dx/3500 xL Dx Genetic Analyzer. Software: uTYPE CDx HLA Sequence Analysis Software running on Windows 10 PC. Standardized database: IPD-IMGT/HLA.

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, HLA-A*02:02, HLA-A*02:03, or HLA-A*02:06 positive; HLA-A*02:05 negative).

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)

Reference Devices

• SSP UniTray with UniMatch Plus interpretation software
• Applied Biosystems 3500 Dx /3500 xL Dx Genetic Analyzer CS2 (BK110039)

Submission Summary (Full Text)

{0}

ONE LAMBDA
A Thermo Fisher Scientific Brand

One Lambda, Inc.
22801 Roscoe Blvd.
West Hills, CA 91304
Tel [phone]
Fax [phone]
www.onelambda.com

## 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: Traditional

2. Date Prepared: May 17, 2024

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: [phone]
Email: [e-mail]

Alternate: Angela Estany
Title: Sr. Director, Regulatory Affairs and Quality
Address: One Lambda, Inc.
22801 Roscoe Boulevard
West Hills, CA 91304
USA
Tel: [phone]
Email: [e-mail]

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{1}

**ONE LAMBDA**^{}[] A Thermo Fisher Scientific Brand

One Lambda, Inc.^{}[] 22801 Roscoe Blvd.^{}[] ^{}[] West Hills, CA 91304^{}[] ^{}[] Tel [phone]^{}[] ^{}[] Fax [phone]^{}[] ^{}[] www.onelambda.com

#### 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 | Traditional BK241074 | 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/ BR220737 | 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. 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

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{2}

ONE LAMBDA

A Thermo Fisher Scientific Brand

One Lambda, Inc.

22801 Roscoe Blvd.

West Hills, CA 91304

Tel [phone]

Fax [phone]

www.onelambda.com

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®)
- 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®)

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{3}

**ONE LAMBDA**^{}[] A Thermo Fisher Scientific Brand

One Lambda, Inc.
22801 Roscoe Blvd.
West Hills, CA 91304
Tel [phone]
Fax [phone]
www.onelambda.com

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).

A summary of the technological characteristics is as follows:

**Table 5: Comparison with Proposed Predicate Device**

| | Predicate Device (BR220737) | New Device (BK241074) |
| --- | --- | --- |
| **Device Name** | SeCore™ CDx HLA Sequencing System | Same |
| **Submission Number** | BR220737 | Pending |
| **Regulation Number** | 21 CFR 866.5960 | Same |
| **Regulation Name** | Human leukocyte antigen typing companion diagnostic test | Same |

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{4}

ONE LAMBDA

A Thermo Fisher Scientific Brand

One Lambda, Inc.

22801 Roscoe Blvd.

West Hills, CA 91304

Tel [phone]

Fax [phone]

www.onelambda.com

| | Predicate Device (BR220737) | New Device (BK241074) | | |
| --- | --- | --- | --- | --- |
| 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 HLA-A*02:01 positive patients with unresectable or metastatic uveal melanoma who may benefit from treatment with KIMMTRAK® (tebentafusp-tebn) when used in accordance with approved therapeutic labeling. | 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) | 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 Uveal Melanoma patient population. | For use in the unresectable or metastatic uveal melanoma and the unresectable or metastatic synovial sarcoma patient populations. | | |
| Assay Method | Sequence Based Typing | Same | | |
| Reactive Ingredient | Genomic DNA | Same | | |

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{5}

ONE LAMBDA

A Thermo Fisher Scientific Brand

One Lambda, Inc.

22801 Roscoe Blvd.

West Hills, CA 91304

Tel [phone]

Fax [phone]

www.onelambda.com

| | Predicate Device (BR220737) | New Device (BK241074) |
| --- | --- | --- |
| 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.

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