(86 days)
The Bio-Rad VARIANT II TURBO Link Hemoglobin Alc Program is intended for the percent determination of hemoglobin A1c in human whole blood using ion-exchange high-performance liquid chromatography (HPLC).
The VARIANT II TURBO Link Hemoglobin A Ic Program is for use with the VARIANT II TURBO Link Hemoglobin Testing System interfaced with an automated sample transport system.
The Bio-Rad VARIANT II TURBO Link Hemoglobin AIc Program is Professional Use Only. Measurement of hemoglobin A Ic is effective in monitoring long-term glycemic control in individuals with diabetes mellitus.
The VARIANT II TURBO Link Hemoglobin Testing System is the next generation Instrument VARIANT II TURBO Hemoglobin Testing System. It integrates the VARIANT II TURBO with the Sysmex HST-N (Hematology Sample Transportation)/XN-9000 TLA systems to allow management of patient sample tubes with A 1c order on the same platform. The VARIANT II TURBO Link system communicates with the Sysmex HST-N/XN-9000 TLA hardware and software in order to receive, identify, inject, and analyze samples with an A 1 c order.
The VARIANT II TURBO Link Hemoglobin Testing System is a fully automated, highthroughput hemoglobin analyzer. It consists of three modules - the VARIANT II TURBO Link Chromatographic Station (VCS), the VARIANT II TURBO Link Sampling Station (VSS), and the Reagent Reservoir Module. In addition, a personal computer (PC) is used to control the VARIANT II TURBO Link system using Clinical Data Management (CDM™) software.
Here's an analysis of the acceptance criteria and study information for the Bio-Rad VARIANT™ II TURBO Link Hemoglobin A1c Program, based on the provided text:
Premarket Notification (510(k)) Summary: K140801
It is important to note that this 510(k) pertains to a device modification (specifically, software and firmware updates) of an already cleared device, the VARIANT™ II TURBO Link Hemoglobin A1c Program (K070819). 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. Moreover, Risk Analysis and Verification/Validation testing results demonstrate that the changes do not affect product safety, effectiveness, and substantial equivalency claims." Therefore, the "acceptance criteria" for the modified device are primarily centered on demonstrating that the changes do not degrade the performance of the predicate device. The performance claims for the modified device are directly transferred from the predicate.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a modification to an already cleared device and the document states "No change, claims transferred from predicate device" for performance, specific numerical acceptance criteria and reported performance for the modified device itself are not explicitly presented as a new performance study. Instead, the acceptance is based on demonstrating that the software and firmware updates do not negatively impact the performance validated for the predicate device.
The main acceptance criteria for this specific 510(k) effectively become:
- The modified device (with updated software and firmware) performs as safely and effectively as the predicate device.
- Risk mitigations, hazard controls, and residual risks are as safe and effective as the predicate device.
- Design verification/validation tests met established acceptance criteria (which implicitly refer to the predicate's performance).
| Acceptance Criteria Category | Specific Criteria (Implicitly from Predicate) | Reported Device Performance (Modified Device) |
|---|---|---|
| Performance Claims | Maintain all performance specifications and claims of the predicate device (K070819). The predicate device is certified by NGSP as traceable to the Diabetes Control and Complications Trial (DCCT) Reference method. | "No change, claims transferred from predicate device." The verification/validation testing demonstrated that the changes did not affect product safety, effectiveness, and substantial equivalency claims, implying that the modified device maintained the predicate's performance. |
| Safety and Effectiveness | Device modifications do not introduce new safety concerns or reduce effectiveness compared to the predicate device. | "Risk Analysis and Verification/Validation testing results demonstrate that the changes do not affect product safety, effectiveness, and substantial equivalency claims." |
| Functional Integrity | The new CDM Software version 5.2.1, new reporting units (mmol/mol HbA1c (IFCC), %HbA1c (JDS)), new printing options (Export to PDF), and updated firmware versions function as intended without adverse impact. | "The software updates include customer requested features, whereas both software and firmware include specific defect fixes... 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." |
| Substantial Equivalence | Demonstrated substantial equivalence to the predicate device (K070819). | "When considering the similarities of the intended use, general features and characteristics of the assay, and use of the same technology, it can be concluded that the VARIANT II TURBO Link Hemoglobin A1c Program is substantially equivalent to the cleared and currently marketed predicate device." (This is the overall conclusion of the 510(k) submission based on the studies performed). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly provide details on a test set sample size or data provenance in the context of a new clinical or performance study for the modified device. The studies conducted were primarily an engineering verification and validation to affirm that the software and firmware changes did not degrade performance.
The studies mentioned are:
- Risk Analysis (FMEA): Identified and mitigated risks associated with modifications.
- Verification and Validation Testing: Evaluated the modified product against acceptance criteria to ensure safety, effectiveness, and substantial equivalence to the predicate.
Since the performance claims are transferred from the predicate device (K070819), any "test set" for performance evaluation would have been part of the original predicate's clearance. This submission indicates that existing product risk tables and customer complaints were reviewed, suggesting that real-world operational data (retrospective, ongoing) might have informed the risk analysis process.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document does not describe the use of experts to establish a "ground truth" for a test set in the conventional sense of a diagnostic performance study. The focus is on demonstrating that software and firmware changes do not compromise the previously established performance.
The "ground truth" for the original HbA1c measurement performance (predicate device) is stated as being certified by the NGSP as traceable to the Diabetes Control and Complications Trial (DCCT) Reference method. This is an external, highly standardized, and internationally recognized reference method, not established by individual experts for this specific submission.
The risk analysis process involved a "trained risk assessment team," but their qualifications and exact number are not specified, nor were they establishing clinical ground truth.
4. Adjudication Method for the Test Set
No adjudication method for a test set is mentioned, as this submission focuses on verification/validation of software/firmware changes and demonstrating substantial equivalence to a predicate device, rather than a new primary diagnostic performance study requiring expert adjudication of cases.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
No MRMC study was performed or described. This device is an automated, high-throughput hemoglobin analyzer, not a diagnostic imaging AI tool requiring human "readers" or "assistance."
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
Yes, the device (both predicate and modified) is inherently a standalone algorithm (or automated system) without human-in-the-loop performance influencing the primary measurement. It's a fully automated analyzer that performs ion-exchange high-performance liquid chromatography. The "algorithm" is integral to its operation, but it's not a separate software AI algorithm in the contemporary sense of providing diagnostic interpretations to a human. The updated software and firmware control the instrument itself.
The verification and validation "determined whether risk mitigations, hazard controls, and residual risks were as safe and effective as the predicate device," which implies standalone performance of the modified system.
7. The Type of Ground Truth Used
The "ground truth" for the overall performance of the HbA1c measurement method (which is unchanged from the predicate) is traceable to the Diabetes Control and Complications Trial (DCCT) Reference method, as certified by the NGSP (National Glycohemoglobin Standardization Program). This is a highly standardized and validated reference method for HbA1c.
8. The Sample Size for the Training Set
No training set is mentioned. This is not an AI/Machine Learning device that undergoes a "training" phase with a dataset. It's an analytical instrument.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set was used.
§ 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).