(24 days)
For in vitro diagnostic use only. VITROS Chemistry Products d%A1c Reagent Kit is used to determine the percent glycated hemoglobin (%A1c) in human whole blood by quantitative measurement of hemoglobin (Hb) and hemoglobin A1c (HbA1c). Measurements of percentage A1c are effective in monitoring long-term glycemic control in individuals with diabetes mellitus.
For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 18 is used in conjunction with VITROS Chemistry Products FS Calibrator 1 to calibrate VITROS 5,1 FS Chemistry Systems for the calculation of percent glycated hemoglobin (%A1c).
For in vitro diagnostic use only. VITROS Chemistry Products FS Calibrator 1 is used in conjunction with VITROS Chemistry Products Calibrator Kits 16, 17, 18, 19 and 28 to calibrate VITROS 5,1 FS Chemistry Systems.
VITROS Chemistry Products d%A1c Reagent Kit, VITROS Chemistry Products Calibrator Kit 18, and VITROS Chemistry Products FS Calibrator 1 are combined with the VITROS 5,1 FS Chemistry System to perform the VITROS d%A1c assay.
VITROS d%A1c Reagent Kit contains two unique dual chambered reagent packs containing ready to use liquid reagents that are used to measure both hemoglobin A1c (HbA1c) and hemoglobin (Hb).
Hemoglobin A1c Reagent Pack (HbA1c)
The R1 chamber (HbA1c Reagent 1) consists of:
HbA1c antibody (ovine serum)
Buffers
Stabilizers
Preservatives
The R2 chamber (HbA1c Reagent 2) consists of:
HbAlc Polyhapten
Buffers
Stabilizers
Preservatives
Hemoglobin Reagent Pack (Hb)
The R1 chamber (Hb Reagent 1) consists of:
Buffer
Stabilizers
Preservatives
The R2 chamber (Hb Reagent 2) contains Hemolyzing Reagent, which consists of:
Tetradecyltrimethylammonium bromide (TTAB)
Acceptance Criteria and Study Details for VITROS Chemistry Products d%A1c Reagent Kit (K060650)
This submission (K060650) describes a modification to an existing device, the VITROS Chemistry Products d%A1c Reagent Kit. The primary change is the automation of the hemolysis step, previously a manual pretreatment. Therefore, the study focuses on demonstrating substantial equivalence to the predicate device, not establishing entirely new performance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document doesn't explicitly state quantitative acceptance criteria in terms of specific performance metrics (e.g., precision, accuracy thresholds). Instead, the acceptance criterion for this 510(k) is substantial equivalence to the predicate device, particularly regarding the performance of the modified reagent kit.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Substantial Equivalence to the predicate device (VITROS Chemistry Products %A1c Reagent Kit) in terms of: | "Equivalence was demonstrated using manufactured reagents along with patient and quality control samples with measured %A1c values spanning the reportable range." |
| - Measurement of %A1c | The modified device performs the quantitative measurement of Hb and HbA1c to determine %A1c. |
| - Clinical Utility | Measurements of percentage A1c are effective in monitoring long-term glycemic control in individuals with diabetes mellitus (same as predicate). |
| - Reportable Range | No change; 4-14 %A1c NGSP (same as predicate). |
| - Basic Principle | No change; Turbidimetric inhibition immunoassay (same as predicate). |
| - Reagent Characteristics | Liquid ready to use (no change). |
| - Instrumentation | VITROS 5,1 FS Chemistry System (no change). |
Note: The primary difference and therefore the focus of demonstrating equivalence is the automated hemolysis step. The submission implicitly asserts that the performance of the assay with the automated hemolysis is comparable to the predicate's performance with manual hemolysis, thus meeting the substantial equivalence criterion.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document states "patient and quality control samples with measured %A1c values spanning the reportable range." However, a specific number of samples (patients or QC samples) used in the test set is NOT provided.
- Data Provenance: The document does not specify the country of origin for the data. The data is retrospective, as it compares the performance of the modified device to a previously cleared predicate device using existing methodologies. It used "manufactured reagents" (presumably, from the submitter) and "patient and quality control samples."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This type of in vitro diagnostic device (reagent kit) typically does not involve human experts establishing "ground truth" for individual patient samples in the same way, for example, a radiology AI device would. Instead, the ground truth for an HbA1c assay is established through reference methods and calibration standards.
- Number of Experts: Not applicable in the context of clinical expert review for individual cases.
- Qualifications of Experts: Not applicable. The "ground truth" for the predicate device and implicitly for the modified device is linked to established standardization programs. The predicate device is "Traceable to the Diabetes Control and Complications Trial (DCCT) and IFCC reference methods. Certified by the National Glycohemoglobin Standardization Program (NGSP)." The modified device states "No change expected, NGSP certification testing is currently in progress." This indicates that compliance with these established external standards serves as the definition of "ground truth" for accuracy.
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1, 3+1) are typically used in studies where there is disagreement among human readers or expert reviewers to derive a consensus ground truth. This is not applicable here as the "ground truth" is derived from standardized reference methods and the focus is on analytical performance comparison.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No. This type of study is not relevant for a reagent kit used in an automated chemistry system. MRMC studies are designed to assess the impact of a device on human reader performance, particularly in image interpretation or diagnostic decision-making scenarios. The VITROS d%A1c Reagent Kit is for automated quantitative measurement.
- Effect size of human readers improvement: Not applicable.
6. Standalone Performance Study
- Was a standalone study done? Yes, in the sense that the performance of the VITROS Chemistry Products d%A1c Reagent Kit (modified) on the VITROS 5,1 FS Chemistry System was evaluated as a complete system (algorithm/device only). The study's objective was to demonstrate its performance and establish substantial equivalence to the predicate device. The results are implied by the statement: "Equivalence was demonstrated using manufactured reagents along with patient and quality control samples."
7. Type of Ground Truth Used
The ground truth for this device is based on reference methods and standardization programs for HbA1c measurement.
- The predicate device is "Traceable to the Diabetes Control and Complications Trial (DCCT) and IFCC reference methods. Certified by the National Glycohemoglobin Standardization Program (NGSP)."
- The modified device stated "NGSP certification testing is currently in progress," indicating adherence to these recognized standards as the ultimate ground truth.
- The comparison study likely used samples with values established by these reference methods or by the predicate device (which is itself traceable).
8. Sample Size for the Training Set
- Not Applicable. This is a reagent kit and chemistry system that performs a quantitative assay, rather than a machine learning algorithm that requires a "training set" in the conventional sense. The "training" of such a system involves chemical and engineering optimization, not data-driven machine learning model training.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no machine learning model training set in the typical sense, there is no "ground truth" for a training set to be established. The system's accuracy and performance are inherently linked to its chemical reactions, instrumentation, and calibration using standardized calibrators.
§ 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).