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510(k) Data Aggregation
(233 days)
DIAZYME GLYCATED SERUM PROTEIN POC TEST KIT
The Diazyme Glycated Serum Protein POC Test Kit is intended for the quantitative determination of glycated serum proteins (GSP; fructosamine) in serum. Fructosamine is representative of blood glucose levels over the course of 2-3 weeks. The measurement of glycated serum proteins is useful for monitoring diabetic patients. For in vitro diagnostic use only.
Fructosamine is formed due to a non-enzymatic Maillard reaction between glucose and amino acid residues of serum proteins. It is reported in medical literature that 80% of measured glycated serum proteins are glycated albumins. In diabetic patients, elevated blood glucose levels correlate with increased fructosamine formation. Glycated serum proteins (GSP; fructosamine) are a medium term indicator of diabetic control (2-3 weeks).
The Diazyme Glycated Serum Protein POC Assay uses proteinase K to digest GSP into low molecular weight glycated protein fragments (GPF), and uses Diazyme's specific fructosamiase™, a microorganisms originated amadoriase to catalyze the oxidative degradation of Amadori product GPF to yield peptide fragments (PF) or amino acids, glucosone and H2O2. The H2O2 released is measured by a colorimetric Trinder end-point reaction. The absorbance at 546 nm is proportional to the concentration of glycated serum proteins. The SMART analyzer calculates the GSP concentrations of patient serum specimens by use of a lot specific calibration curve. The lot specific curve is represented in a Calibration card (RFID) provided with each GSP POC Test Kit.
SMART Analyzer (K092911) 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 cuvette. The instrument only uses the Diazyme Reagent System (DRS) cuvette and caps and performs assay with a preprogrammed Radio Frequency ID (RFID) card. The DRS cuvette is supplied prefilled with Reagent 1 (R1) and the DRS cap is supplied prefilled with Reagent 2 (R2). The DRS cuvette and caps are kept separate until use. Users are instructed (see proposed labeling) to add 40ul of sample to the DRS cuvette prefilled with R1 containing proper buffer. Users are then instructed to snap in place DRS cap and insert into analyzer. The instrument warms the cuvette to 37°C and after a predefined period adds the reagent R2 found in the DRS cap. The reagents and samples are mixed magnetically and absorbance readings are taken at 546nm. The lot specific RFID card contains reagent addition time, mixing time, reading time and lot specific calibration curve.
The Diazyme GSP POC Test Kit system thus consists of the following:
- . GSP POC Test Kit. Reagents are provided in prefilled tubes, cuvettes and cuvette caps. The DRS cuvette and cuvette caps can only work with the SMART analyzer.
The provided document describes the Diazyme Glycated Serum Protein POC Test Kit and its performance characteristics. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" for precision or linearity. However, it presents the performance data in a way that implies these are the achieved results for demonstrating substantial equivalence. The predicate device's performance is listed, and the new device's performance is compared for similarity.
| Performance Metric | Acceptance Criteria (Implied from Predicate/Good Practice) | Reported Device Performance (Diazyme GSP POC Test Kit) |
|---|---|---|
| Linearity | Similar to predicate (up to 1354 µmol/L) | 61 to 1348 µmol/L (Linear from 2 to 1348 µmol/L tested) |
| Precision (Within %CV) | Less than 2.0% CV (predicate) | ≤ 6.1% CV (Serum Level 1) |
| ≤ 1.5% CV (Serum Level 5) | ||
| Precision (Total %CV) | Less than 2.0% CV (predicate) | ≤ 5.6% CV (Serum Level 1) |
| ≤ 1.8% CV (Serum Level 5) | ||
| Accuracy (Correlation Coefficient) | Similar to predicate (0.9966) | 0.9975 |
| Accuracy (Slope) | Similar to predicate (0.9542) | 0.9737 |
| Accuracy (Intercept) | Similar to predicate (14.57 µmol/L) | 0.6859 µmol/L |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size for Comparison Study: 54 serum specimens
- Test Set Sample Size for Precision Study: 5 serum samples, each tested 80 times (2 runs/day, duplicates, over 20 working days). This implies a total of 400 individual measurements (5 samples * 80 measurements/sample).
- Data Provenance: Not explicitly stated regarding country of origin. The study appears to be prospective for the device's performance characterization, as it describes actively testing samples with the new device and comparing them to results from the predicate.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is an in-vitro diagnostic assay that measures a biomarker. The "ground truth" for the test set is established by the well-characterized predicate device (Diazyme Glycated Serum Protein Assay on Hitachi 917 analyzer). No human experts are used to establish a subjective "ground truth" for a diagnostic image or interpretation.
4. Adjudication Method for the Test Set
Not applicable. As this is a quantitative measurement against a predicate, there is no expert adjudication process. The comparison is statistical.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is a point-of-care in-vitro diagnostic test, not an imaging device or AI-assisted diagnostic tool that involves human reader interpretation. Therefore, an MRMC study is not relevant.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the performance data presented (Linearity, Precision, Interference, and Comparison Studies) are all for the Diazyme GSP POC Test Kit operating in a standalone capacity, measuring GSP levels in serum samples without human intervention in the result generation itself (beyond sample loading). The SMART Analyzer with its RFID card is essentially the "algorithm" that interprets the optical readings and calculates the GSP concentration.
7. The Type of Ground Truth Used
The ground truth used for the comparison study is the measurement result from the legally marketed predicate device (Diazyme Glycated Serum Protein Assay on Hitachi 917 analyzer (K110188)). For the linearity, precision, and interference studies, the "ground truth" is based on the known concentrations of the prepared samples or spiked substances.
8. The Sample Size for the Training Set
Not applicable. This device is an analytical instrument and reagent kit, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its performance is based on chemical reactions and optical detection. The RFID card contains a "lot specific calibration curve," which is developed by the manufacturer. While this involves data, it's not a "training set" for an AI model.
9. How the Ground Truth for the Training Set Was Established
Not applicable. See point 8. The "calibration curve" stored on the RFID card is established through a calibration process using known standards (calibrators) to ensure accurate measurements across the reportable range. This is a standard procedure for IVD assays.
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