(29 days)
The Bio-Rad VARIANT™ II TURBO HbA Ic Kit - 2.0 is intended for the quantitative determination of hemoglobin Alc in human whole blood using ion-exchange high performance liquid chromatography (HPLC) on the VARIANT II TURBO Hemoglobin Testing System. Measurement of hemoglobin Alc is effective in monitoring long term glycemic control in individuals with diabetes mellitus. The Bio-Rad VARIANT II TURBO HbAlc Kit - 2.0 is intended for professional Use.
The VARIANT II TURBO Hemoglobin Testing System is the next generation HPLC system with higher volume capability when compared to the VARIANT II testing system. The VARIANT II TURBO Hemoglobin Testing System provides an integrated method for sample preparation, separation, and determination of specific hemoglobin in whole blood. It is a fully automated, high-throughput system. It consists of 2 modules: the VARIANT II TURBO Sampling Station (VSS) and the VARIANT II TURBO Chromatographic Station (VCS). A personal computer (PC) is used to control the VARIANT II TURBO System using Clinical Data Management (CDM™) software. The CDM software supports import of sample information from and export of patient results to a Laboratory Information System (LIS). Control results are displayed on Levy-Jennings Charts and are exportable to Unity Real Time™.
The provided text describes a Special 510(k) Summary for a Device Modification related to the Bio-Rad VARIANT™ II TURBO HbA1c Kit - 2.0. This type of submission is for modifications to a legally marketed device that do not significantly alter its performance specifications, intended use, or operating principles.
Crucially, the document explicitly states:
- "When compared to the predicate device, there are no changes to the performance specifications, intended or indications for use, or operating principles."
- "Performance Claims: No change, claims transferred from predicate device."
Therefore, this specific submission does not present new acceptance criteria or a new study to prove device performance, as the performance claims are directly transferred from the predicate device (K122472). The modifications described are primarily software and firmware updates, customer-requested features, and defect fixes.
The document focuses on demonstrating that these changes do not affect product safety, effectiveness, and substantial equivalency claims to the predicate device. This is achieved through a risk management process, review of modifications, and design verification/validation tests.
Based on the provided text, I cannot extract the specific acceptance criteria and a study proving those criteria were met for this modified device because the submission relies on the established performance of its predicate.
However, I can describe what the document does provide in relation to an implicit "acceptance" or validation of the modifications:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table of new acceptance criteria for performance, nor new reported device performance data, because the performance claims are stated to be unchanged from the predicate device.
Instead, the "acceptance criteria" for the modifications themselves relate to successful verification and validation (V&V) testing.
| Acceptance Criteria (for modifications) | Reported Device Performance (for modifications) |
|---|---|
| "Determined whether risk mitigations, hazard controls, and residual risks were as safe and effective as the predicate device." | "Risk Analysis and Verification/Validation testing results demonstrate that the changes do not affect product safety, effectiveness, and substantial equivalency claims." |
| "Design verification/validation tests met established acceptance criteria." | |
| "The modified product [is] safe, effective, and comparable to the predicate device." | |
| "Modified product [is] safe, effective, and comparable to the predicate device." (Derived from risk management report conclusion) | (See above) |
| No changes to performance specifications, intended use, indications for use, or operating principles (criteria implicitly met for substantial equivalence) | "When compared to the predicate device, there are no changes to the performance specifications, intended or indications for use, or operating principles." |
2. Sample Size Used for the Test Set and Data Provenance
The document details "design verification/validation tests" and a risk management process, but does not specify sample sizes for these tests. It also does not explicitly mention the country of origin or whether the data was retrospective or prospective, as the focus is on the software and firmware changes and their impact on safety and effectiveness, rather than a clinical performance study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document states: "For each identified risk, a Failure Mode and Effects Analysis (FMEA) was conducted. This was performed in a systematic manner by a trained risk assessment team until consensus was reached that an adequate analysis had been performed."
- Number of Experts: Not explicitly stated, but implies a "team" (more than one).
- Qualifications of Experts: Described as a "trained risk assessment team." No further specific qualifications (e.g., radiologist with X years of experience) are provided, which is typical for device engineering and risk management teams.
4. Adjudication Method for the Test Set
The FMEA process involved a "trained risk assessment team until consensus was reached," suggesting a form of group adjudication, but no specific method like "2+1" or "3+1" is detailed. It implies a collaborative decision-making process to reach agreement on risk identification and mitigation.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices that involve human interpretation of results, where the AI might assist or replace that interpretation. This device is an automated in vitro diagnostic system for measuring HbA1c, and its modifications are software/firmware related, not involving human interpretation of clinical images or data in a way that would necessitate an MRMC study.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
The device itself is an automated system. The "design verification/validation tests" would have evaluated the performance of the modified software and firmware in a standalone manner, integrated into the instrument, to ensure it met its functional and safety requirements. However, the document doesn't provide details on the specific "standalone" tests conducted beyond stating they "met established acceptance criteria" for the modifications.
7. The Type of Ground Truth Used
For the modifications, the "ground truth" was established based on:
- Identified potential risks and hazards (from reviewing modifications, design inputs, existing risk tables, customer complaints, and IEC 62304:2009 requirements).
- Predicate device claims and performance established during its initial clearance (K122472), against which the modified device's safety, effectiveness, and substantial equivalency were assessed.
For the predicate device's original performance claims (which are transferred), the ground truth for HbA1c measurement is based on:
- Certification by the NGSP as traceable to the Diabetes Control and Complications Trial (DCCT) Reference method.
- Certification by the IFCC as traceable to the IFCC Reference Measurement Procedure.
8. The Sample Size for the Training Set
Not applicable. This submission is for modifications to an existing in vitro diagnostic device, not a new algorithm that requires a "training set" in the context of machine learning. The software and firmware updates "include customer requested features, whereas both software and firmware include specific defect fixes," implying development rather than a machine learning training process.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no mention of a machine learning "training set" in this context.
§ 864.7470 Glycosylated hemoglobin assay.
(a)
Identification. A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a , A1b , and A1c ) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.(b)
Classification. Class II (performance standards).