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510(k) Data Aggregation
(115 days)
The Diazyme high sensitivity C-reactive protein (hsCRP) POC Test Kit is for the in vitro quantitative determination of C-reactive protein (CRP) in human venous whole blood on SMART analyzers. Measurement of CRP is of use for the detection and evaluation of inflammatory disorders and associated diseases, infection and tissue injury. For in vitro diagnostic use only.
The Diazyme hsCRP POC control set is intended for use as quality controls for the Diazyme hsCRP POC Test Kit. For in vitro diagnostic use only.
Diazyme's hsCRP POC Test Kit is based on a latex enhanced immunoturbidimetric assay on Diazyme's SMART analyzer. Agglutination occurs when an antigen-antibody reaction occurs between CRP in a sample and anti-CRP which has been sensitized to latex particles. This agglutination is detected as an absorbance change (700 nm), with the magnitude of the change being proportional to the quantity of CRP in the sample. The instrument calculates the CRP concentration of patient specimen by use of a lot specific calibration curve that is stored in an RFID card provided with each hsCRP POC kit. The RFID card is inserted in the SMART analyzer and is needed for every single run.
Diazyme hsCRP POC Control Kit is intended for use as quality controls for the Diazyme hsCRP POC Test Kit and is packaged separately. The quality controls assist laboratory users in verification steps ensuring that the assay reagents are functioning correctly. OC 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 OC materials fall outside laboratory acceptable range, users are instructed to re-test and call manufacturer customer service if problem persists.
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 20ul of sample to the DRS cuvette prefilled with R1 containing proper amount of detergent for whole blood lysis. 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 700nm. The lot specific RFID card contains reagent addition time, mixing time, reading time and calibration curve.
The Diazyme hsCRP POC Test Kit system thus consists of the following:
- hsCRP 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.
- hsCRP POC Control Kit. Controls are provided for quality control of the . hsCRP POC Assay.
Equipment needed for Diazyme hsCRP POC Test Kit:
• SMART Analyzer (K092911).
Kit components
(Candidate device)
Reagent 1
40 DRS cuvette (prefilled)
- · 100 mM TrisCl buffer
Reagent 2
40 DRS caps (prefilled)
- Suspension of anti-human CRP polyclonal antibody coated latex particles . (< 0.5%).
Calibrator
1 x preprogrammed lot specific RFID card in each kit
1
Control Set
l x 1.0 mL Control 1
l x 1.0 mL Control 2
The document describes the Diazyme hsCRP POC Test Kit, an in vitro diagnostic device for quantitative determination of C-reactive protein (CRP) in human venous whole blood. The device is intended for the detection and evaluation of inflammatory disorders, associated diseases, infection, and tissue injury.
Here's an analysis of the acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance:
The document outlines several performance tests with specific acceptance criteria and the observed results.
| Performance Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Precision (Internal) | Within-run and total CV% (specific values not explicitly stated, but generally low for diagnostic devices) | Within Run CV%:- 0.813 mg/L: 9.62%- 3.186 mg/L: 2.83%- 12.560 mg/L: 1.79%Total Precision CV%:- 0.813 mg/L: 8.17%- 3.186 mg/L: 3.09%- 12.560 mg/L: 2.12% |
| Precision (External) | Within-run and total CV% (specific values not explicitly stated, but generally low for diagnostic devices) | Within Run CV% (POL sites):- 0.798 mg/L: 4.67%- 4.796 mg/L: 7.02%- 0.758 mg/L: 9.04%- 17.796 mg/L: 4.18%- 7.780 mg/L: 5.43%- 18.725 mg/L: 5.02%Total CV% (POL sites):- 0.798 mg/L: 8.58%- 4.796 mg/L: 7.37%- 0.758 mg/L: 8.13%- 17.796 mg/L: 4.02%- 7.780 mg/L: 5.24%- 18.752 mg/L: 4.78% |
| Linearity | (Implicitly to support AMR) | Linearity data and LOQ data support Analytical Measuring Range (AMR) of 0.47 mg/L to 23.0 mg/L. |
| Limit of Detection (LOD) | (Implicitly to determine lower detection limit) | LOD is 0.15 mg/L |
| Limit of Quantitation (LOQ) | (Implicitly to determine lower quantitation limit) | LOQ is 0.47 mg/L |
| Analytical Specificity (Interference) | < 10% deviation from samples without interferents | Common endogenous substance interference: No significant interference up to: Triglyceride 1000 mg/dL, Ascorbic Acid 176 mg/dL, Bilirubin 40 mg/dL, Bilirubin Conjugated 30 mg/dL, Hemoglobin 20 g/dL, Rheumatoid Factor 250 IU/mL. Common exogenous substance interference: No significant interference up to: Oxaloacetate 200 μM, Glutathione 200 μM, Isoniazid 200 μM, L-DOPA 200 μM. |
| Method Comparison (Internal) | Slope = 0.90~1.10; r2 ≥ 0.95 | Whole blood application: Slope = 0.9871 (0.8122-1.0325), Intercept = -0.4004 (-0.2810 to 0.0540), Correlation coefficient = 0.9511. Range of values: 0.47-22.50. Meets criteria. |
| Method Comparison (External) | Slope = 0.90~1.10; r2 ≥ 0.95 | 3 POL Site Combined: Slope = 0.9712 (0.9420-1.0056), Intercept = -0.0870 (-0.0463-0.0686), Correlation coefficient = 0.9836. Range of values: 0.47-22.79. Meets criteria. (Individual site results also within range: Site 1: 0.9195, 0.9889; Site 2: 1.0125, 0.9811; Site 3: 1.0073, 0.9858) |
| Expected Value/Reference Range | < 5.0 mg/L in 95% of the population tested (verified transferability from predicate) | Verified: < 5.0 mg/L in 95% of the population tested (based on 150 healthy individuals). |
2. Sample Size Used for the Test Set and Data Provenance:
- Precision (Internal): Three whole blood specimens (0.80 mg/L, 3.25 mg/L, and 12.50 mg/L CRP) were tested. Each sample had 40 total data points (4 runs/day over 10 days for each of three analyzers). The study was performed at Diazyme Laboratories, indicating in-house data. The document does not specify the origin of the whole blood specimens (e.g., country). It is a prospective study as tests were performed specifically for device evaluation.
- Precision (External): Six whole blood samples across a range of CRP levels were used. At each of three Physician Office Laboratories (POLs), two whole blood samples were tested. Each sample was run 4 times per day for 5 days. This implies data from POL sites, likely within the USA given the company address. It is a prospective study.
- Linearity: Eleven levels of linearity materials prepared by diluting whole blood samples. Tested in triplicate. Data provenance likely in-house (Diazyme Laboratories).
- Limit of Detection (LOD) & Limit of Quantitation (LOQ): Details on sample types and number for LOD/LOB/LOQ determination are not provided, but the methodology (CLSI EP17-A) implies specific samples designed for this purpose. Data provenance likely in-house.
- Analytical Specificity (Interference): Samples with spiked interfering substances were used. No specific numbers are provided for samples tested per interferent. Data provenance likely in-house.
- Method Comparison (Internal): Forty EDTA whole blood specimens. Correspondent plasma samples were also tested. Data provenance likely in-house (Diazyme Laboratories). This is a prospective study as samples were explicitly collected and tested for comparison.
- Method Comparison (External): One hundred and twenty (120) paired human whole blood-serum samples were collected from individuals. At three POL sites, 40 whole blood samples were tested at each site. The corresponding 120 plasma specimens were tested at Diazyme Laboratories. 116 samples were used after exclusions. Data provenance is multi-site (3 POLs and Diazyme Laboratories), likely within the USA. This is a prospective study.
- Expected Value/Reference Range: 150 whole blood samples from apparently healthy individuals (male and female adults ≥ 18 years of age). Data provenance not explicitly stated but implies collection for this study, likely within the USA. This is a prospective study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
For this device, which is an in vitro diagnostic (IVD) test measuring a biomarker (CRP), the "ground truth" is typically the quantitative value obtained from a reference method or a predicate device. There is no mention of "experts" (e.g., radiologists) establishing a subjective ground truth based on interpretation.
- For Method Comparison studies, the predicate device (Diazyme hsCRP Assay on Hitachi 917 analyzer, K103557) served as the reference method. The "ground truth" for comparison purposes was the measurement obtained from this predicate device. The qualifications of the operators performing these reference measurements (e.g., lab technicians) are not explicitly detailed but are assumed to be standard for clinical laboratory personnel.
4. Adjudication Method for the Test Set:
Not applicable. This is a quantitative diagnostic test for a biomarker, not a device involving subjective interpretation by multiple readers requiring adjudication. The comparison is against an established predicate device.
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:
Not applicable. This device is an in vitro diagnostic assay and does not involve human "readers" interpreting images or clinical cases that could be assisted by AI. It's a standalone quantitative measurement device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, the studies presented are all standalone performance evaluations of the Diazyme hsCRP POC Test Kit. The device provides a quantitative result without human interpretive input beyond sample handling and operational procedures. The precision, linearity, LOD/LOQ, analytical specificity, and method comparison studies evaluate the algorithm's (and instrument's) ability to accurately and precisely measure CRP.
7. The Type of Ground Truth Used:
The ground truth used for the quantitative performance evaluation (method comparison) was the measurements obtained from a predicate device (Diazyme hsCRP Assay on Hitachi 917 analyzer, K103557). For other studies like precision, linearity, and LOD/LOQ, the "ground truth" refers to the expected or target concentrations of CRP in control or spiked samples. For the reference range, it was the distribution of CRP values in apparently healthy individuals.
8. The Sample Size for the Training Set:
The document does not explicitly mention a "training set" in the context of machine learning or AI algorithms. As an immunoturbidimetric assay, it relies on chemical reactions and spectrophotometric measurements, not a trainable algorithm in the typical sense of AI/ML. The "calibration curve" for each lot, stored in an RFID card, is established during manufacturing and is a form of calibration rather than algorithm training.
9. How the Ground Truth for the Training Set Was Established:
Not applicable in the context of AI/ML training. The "ground truth" for the device's calibration curve (if interpreted as analogously to a training set) would be established by measuring known concentrations of CRP calibrators according to established laboratory protocols.
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