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SMART Hemoglobin A1c (Glycated hemoglobin A1c; A1c; HbA1c) Assay Reagent Kit is intended for use with the SMART analyzer for the quantitative determination of stable HbA1c in human capillary and venous whole blood samples. Measurement of hemoglobin A1c is a valuable indicator for long-term diabetic control. For in vitro diagnostic use only.

SMART HbA1c Assay Controls are intended for use as quality controls for the SMART HbA1c Assay reagents. For in vitro diagnostic use only.

SMART analyzer is a compact cuvette based spectrophotometer machine for point-of-care use, designed to analyze readings from single use SMART reagent cuvette. The SMART Analyzer System, consisting of the SMART Analyzer, SMART HbA1c reagent kit and SMART HbA1c Assay Controls, is for in vitro diagnostic use only.

SMART HbAlc Assay Kit contains reagents intended for use with the SMART HbA1c analyzer for the quantitative determination of stable HbA1c in human whole blood samples. Measurement of hemoglobin A1c is a valuable indicator for long-term diabetic control. SMART HbA1c assay reagents are similar to the predicate Direct Enzymatic HbA1c assay reagents (K070734). The similarities and differences in composition and format are noted in Table 1 below. The SMART HbA1c test is an enzymatic assay in which lysed whole blood samples are subjected to extensive protease digestion with Bacillus sp protease. This process releases amino acids including glycated valines from the hemoglobin beta chains. Glycated valines then serve as substrates for specific recombinant fructosyl valine oxidase (FVO) enzyme, produced in E. coli. The recombinant FVO specifically cleaves N-terminal valines and produces hydrogen peroxide. This, in turn, is measured using a horseradish peroxidase (POD) catalyzed reaction and a suitable chromagen. The HbA1c concentration is expressed directly as %HbA1c by use of a lot specific calibration curve that is stored in an RFID card provided with each SMART test kit. The manufacturer of the SMART HbA1c Assay kit is Diazyme Laboratories.

SMART HbA1c Assay Control Kit is intended for use as quality controls for the SMART HbAlc Assay Reagents and is packaged separately. The OC materials were pre market cleared with predicate device (K070734, K050178) and each lot of SMART HbA1c control kits will be tested with the SMART system during value assignment. The quality controls assist laboratory users in verification steps ensuring that the assay reagents are functioning correctly. QC materials are run exactly as samples. Users are instructed to verify the calibration curve with the controls and run controls each time a new lot of reagents are received. If QC materials fall outside laboratory acceptable range, users are instructed to re-test and call manufacturer customer service if problem persists. The manufacturer of the SMART HbA1c Assay Control kit is Diazyme Laboratories.

SMART HbA1c analyzer is a compact cuvette based spectrophotometer (10 inches x 5.5 inches x 5.5 inches) machine for point-of-care testing designed to analyze readings from single use reagent cuvettes. The instrument only uses the Diazyme Reagent System (DRS) cuvettes and caps and performs assay with a preprogrammed Radio Frequency ID (RFID) card. The DRS cuvette is supplied prefilled with R1a and the DRS cap is supplied prefilled with R2. The DRS cuvette and caps are kept separate until use. Users are instructed (see proposed labeling) to prepare hemolysate samples in micro tubes prefilled with Lysis buffer and prepare R1ab mix by transferring R1b from supplied bottle to cuvette. Users are then instructed to transfer hemolysate to cuvette, snap in place DRS cap and insert into analyzer. The instrument warms the cuvette to 37C and after a predefined period adds the second reagent found in the DRS cap. The reagents and samples are mixed magnetically and absorbance readings are taken at 700mm. The lot specific RFID card contains reagent addition time, mixing time, reading time and calibration curve.

The SMART HbA1c Analyzer System thus consists of the following:

1. SMART HbAlc Assay Kit. Reagents are provided in prefilled tubes, cuvettes and cuvette caps. The DRS cuvette and cuvette caps can only work with the SMART HbAlc analyzer.
2. SMART HbA1c Assay Control Kit. Controls are provided for quality control of the SMART Hba1c assay
3. SMART Analyzer. SMART analyzer is a compact cuvette based spectrophotometer machine for point-of-care testing, designed to analyze readings from single use SMART reagent cuvettes.

Here's an analysis of the provided text regarding the acceptance criteria and study for the SMART HbA1c Assay Reagent Kit, SMART HbA1c Assay Control Kit, and SMART Analyzer:

Acceptance Criteria and Device Performance Study for SMART HbA1c Assay System

This submission details the performance verification of the SMART HbA1c Assay System, demonstrating its substantial equivalence to the predicate Diazyme Direct Enzymatic HbA1c Assay (K070734).

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state pre-defined acceptance criteria values for precision or comparison in the same way it presents the results. However, implied acceptance criteria can be inferred from the reported results and the statement that the precision was "acceptable" and correlation was "well." For the purpose of this analysis, I will assume typical acceptable ranges or infer based on the predicate device's performance.

Total Precision CV%
5.6% HbA1c: 2.70%
7.4% HbA1c: 2.50%
11.5% HbA1c: 1.30%

POL Sites Precision (CV%): yielded acceptable precision of CV ≤ 5% for all three levels tested (5.5%, 7.5%, 11.5% HbA1c)

Between Instrument Precision: less than 5% CV
Lot-to-Lot Variation: less than 5% CV |
| Comparison (Correlation) | Correlation coefficient (r) ≥ 0.95 (typical for method comparison) | Correlation coefficient: 0.94
Slope: 0.96
Intercept: 0.30
Range of values tested: 4.5% - 11.1% HbA1c
Conclusion: "correlated well with predicate method" |
| Interference | Less than 10% deviation (stated in text) | Interference: Less than 10% deviation observed for Ascorbic Acid (30 mg/dL), Bilirubin (15 mg/dL), Bilirubin Conjugate (5 mg/dL), Uric Acid (30 mg/dL), Triglyceride (4000 mg/dL), Glucose (5,000 mg/dL), Urea (100 mg/dL). |

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • Precision Study: 3 samples (5.6% HbA1c, 7.4% HbA1c, 11.5% HbA1c control) were tested repeatedly (40 data points per sample across the total study duration for the main precision study). For the POL study, 3 samples (5.5%, 7.5% HbAlc, and 11.5% HbAlc control) were also used. The "panel of 10 blood samples" for between-instrument and lot-to-lot studies indicates 10 unique samples for those specific evaluations.
  • Comparison Study: 64 human whole blood samples.
  • Interference Study: Not explicitly stated how many replicates or unique samples were used for each interferent, but the study was performed for each substance at the specified concentration.
• Data Provenance: The text indicates "human whole blood specimens" and "human whole blood based HbAlc control." No specific country of origin is mentioned, but "physician office laboratories (POL)" are mentioned, implying a domestic (US, given the FDA submission) setting. The studies appear to be prospective as they were specifically designed and executed for this 510(k) submission.

3. Number of Experts and Qualifications for Ground Truth

• The document does not mention the use of experts to establish ground truth.
• For the comparison study, the "predicate method" (Diazyme Direct Enzymatic HbA1c Assay, K070734) serves as the reference, which is an established and likely FDA-cleared laboratory method. For precision, the samples themselves are considered the ground truth, and the device's ability to consistently measure them is assessed.

4. Adjudication Method

• No adjudication method is described as the ground truth is established either by a predicate device or by the inherent properties of the samples used (for precision). This is typical for in vitro diagnostic (IVD) assays where a direct comparison to a reference method is often performed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study was performed. This type of study is more common for imaging-based AI devices where human readers interpret images. For an IVD assay like HbA1c measurement, the "reader" is the instrument itself, and the human interaction is primarily in sample preparation and loading, not interpretation of complex data outputs. The "POL sites" study evaluated instrument performance in different user settings but was not an MRMC study comparing human reader performance.

6. Standalone Performance Study

• Yes, a standalone performance study was performed. The entire document describes the standalone performance of the SMART HbA1c Assay System (reagent kit, control kit, and analyzer). The precision, comparison, and interference studies directly assess the algorithm and instrument's ability to accurately and precisely measure HbA1c without human-in-the-loop interpretation post-measurement. The intent is for the device to provide the final quantitative result.

7. Type of Ground Truth Used

• Comparison Study: The ground truth for the comparison study was the result obtained from the predicate device, the Diazyme Direct Enzymatic HbA1c Assay (K070734).
• Precision Study: The ground truth for the precision study was the expected stable HbA1c concentration of the whole blood specimens and controls.
• Interference Study: The ground truth for the interference study was the known concentration of the analytes in the presence of various interferents, with the expectation that the interferents would not significantly alter the result (less than 10% deviation).

8. Sample Size for the Training Set

• The document does not specify a training set sample size. This is because the device described is an enzymatic assay and analyzer system, not a machine learning or AI model in the modern sense that typically requires a large training dataset for model development. The "calibration curve" mentioned for the RFID card is likely generated through traditional analytical chemistry methods and validated, not "trained" on a large dataset in the AI context.

9. How Ground Truth for Training Set Was Established

• As there's no explicitly defined "training set" in the context of machine learning, the concept of establishing ground truth for it is not applicable here. The device operates based on known enzymatic reactions and spectrophotometric measurements, with calibration established through reference materials. The "lot specific calibration curve" mentioned is derived from the manufacturer's testing and standardization process using reference materials, rather than a data-driven training regimen.

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