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510(k) Data Aggregation
(83 days)
cobas HSV 1 and 2 Test
The cobas® HSV 1 and 2 Test on the cobas® 4800 system is an automated, qualitative in vitro diagnostic test, that utilizes real-time polymerase chain reaction (PCR), for the direct detection and differentiation of Herpes simplex virus 1 and 2 (HSV-1 and HSV-2) DNA in clinician-collected, external anogenital lesion specimens from symptomatic male and female patients. The cobas® HSV 1 and 2 Test is intended for use as an aid in diagnosis of anogenital HSV-1 and HSV-2 infections in symptomatic patients.
Warning: The cobas® HSV 1 and 2 Test is not FDA cleared for use with cerebrospinal fluid (CSF) and is not intended to be used for prenatal screening or for individuals under the age of 18 years.
The Roche Molecular Systems (RMS) cobas® HSV 1 and 2 Test utilizes real-time polymerase chain reaction (PCR) for detection of HSV-1 and HSV-2 DNA in clinician-collected external anogenital lesion specimens, collected in MSwab medium from symptomatic patients.
The cobas® HSV 1 and HSV 2 Test contains two major processes: (1) automated sample preparation to extract nucleic acids from swab specimens; (2) PCR amplification of target DNA sequences using HSV-1 and HSV-2 specific primers, and real-time detection of cleaved fluorescent-labeled HSV-1 and HSV-2 specific oligonucleotide detection probes. An Internal Control (IC), containing unrelated randomized DNA sequence, is added to all samples prior to automated sample preparation and is amplified and detected simultaneously with each sample to monitor the entire process.
The MSwab Collection. Transport and Preservation System (Copan Flock Technologies) is used for specimen collection, transportation and storage of specimen for the cobas " HSV 1 and HSV 2 Test.
The cobas® HSV 1 and HSV 2 Test utilizes six reagent kits:
- cobas® 4800 HSV 1 and HSV 2 Amplification/Detection Kit 1)
- cobas® 4800 HSV 1 and HSV 2 Controls and Cofactor Kit 2)
- cobas® 4800 System Wash Buffer Kit 3)
- cobas® 4800 System Lysis Kit 1 4)
- cobas® 4800 System Internal Control Kit 1 5)
- cobas® 4800 System Sample Preparation Kit 6)
Here's an analysis of the acceptance criteria and study detailed in the provided document for the cobas® HSV 1 and 2 Test:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria in a dedicated table. Instead, it presents performance metrics from various studies, which imply the acceptance thresholds met for FDA clearance. Based on the provided clinical performance data, the implicit acceptance criteria and the reported performance are:
| Performance Metric | Implicit Acceptance Criteria (based on reported performance) | Reported Device Performance (95% CI) |
|---|---|---|
| HSV-1 Clinical Performance (vs. Composite Reference Method) | ||
| Sensitivity | High (e.g., >85%) | 92.9% (85.3% - 96.7%) |
| Specificity | High (e.g., >95%) | 98.8% (96.9% - 99.5%) |
| PPV | High (e.g., >85%) | 95.1% (88.1% - 98.1%) |
| NPV | High (e.g., >95%) | 98.2% (96.0% - 99.2%) |
| HSV-2 Clinical Performance (vs. Composite Reference Method) | ||
| Sensitivity | High (e.g., >90%) | 97.0% (93.2% - 98.7%) |
| Specificity | High (e.g., >90%) | 94.6% (91.0% - 96.8%) |
| PPV | High (e.g., >85%) | 92.6% (87.7% - 95.6%) |
| NPV | High (e.g., >95%) | 97.9% (95.1% - 99.1%) |
| Analytical Sensitivity (LOD) | Detect HSV at very low concentrations | HSV-1: 0.479 TCID50/mL, HSV-2: 0.112 TCID50/mL |
| Precision | Low variability in Ct values at various concentrations | HSV-1 Ct CV: 2.2%, HSV-2 Ct CV: 1.9% at 3 x LOD |
| Reproducibility (Positive Agreement at 1xLOD) | High agreement (e.g., >95%) | HSV-1: 100.0%, HSV-2: 100.0% |
| Reproducibility (Negative Agreement) | High agreement (e.g., >99%) | HSV-1: 99.8%, HSV-2: 100.0% |
| Cross-Reactivity | No false positives with non-HSV organisms | No false positives observed with 71 bacteria, fungi, and viruses |
| Interference | No interference with common substances | No interference detected for most OTC products, whole blood, mucin, urine, feces, human serum albumin (except Vagisil Crème at >10mg) |
2. Sample Size Used for the Test Set and Data Provenance
- Clinical Study Test Set Sample Size: A total of 408 specimens from 205 female and 203 male subjects.
- Data Provenance: The specimens were clinician-collected external anogenital lesion specimens from symptomatic male and female patients attending family planning, OB/GYN, and sexually transmitted disease clinics at eight geographically diverse sites (seven across the United States and one in the United Kingdom). The study was prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not specify the number of individual experts or their qualifications used to establish the ground truth. It states that the ground truth was "established compared to a composite Reference Method derived from the combined results of culture (ELVIS® HSV ID and D3 Typing Test) and Sanger sequencing using the 'any positive rule'." This implies laboratory testing by trained personnel rather than clinical expert consensus.
4. Adjudication Method for the Test Set
The adjudication method for the clinical test set ground truth was a "composite Reference Method derived from the combined results of culture (ELVIS® HSV ID and D3 Typing Test) and Sanger sequencing using the "any positive rule"." This means if either culture or Sanger sequencing was positive, the specimen was considered positive for the ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This device is an in-vitro diagnostic (IVD) test, where the performance is assessed by comparing its output to a reference method, not by how human readers improve with or without AI assistance. The "reader" in this context is the instrument itself.
6. Standalone Performance Study
Yes, a standalone performance study was done. The entire document focuses on the performance of the algorithm only (the cobas® HSV 1 and 2 Test on the cobas® 4800 system) without human-in-the-loop performance being part of the primary evaluation metrics for FDA clearance in this context. The clinical performance tables (Table 14 and 15) directly compare the device's results to the reference methods.
7. Type of Ground Truth Used
The primary ground truth for the clinical study was a composite reference method combining:
- Culture: ELVIS® HSV ID and D3 Typing Test
- Sanger Sequencing: PCR followed by bi-directional Sanger sequencing for HSV-1 and HSV-2 DNA.
This composite ground truth used an "any positive rule."
8. Sample Size for the Training Set
The document does not specify a sample size for a training set. This is because the submission primarily describes the validation studies for an IVD kit, not a machine learning algorithm that typically requires a distinct training phase. The development of the assay (primer/probe design, optimization, etc.) would historically involve various samples, but these are not explicitly termed a "training set" in the context of this regulatory filing.
9. How the Ground Truth for the Training Set Was Established
As no specific "training set" is mentioned in the context of a machine learning algorithm, the method for establishing its ground truth is not applicable or described in this document. The assay's analytical characteristics (e.g., target selection, primer and probe design) imply bioinformatic and laboratory validation during its development, but not in the sense of establishing ground truth for a distinct training dataset for a learning algorithm.
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