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K Number
K160062
Device Name
AUTION ELEVEN Semi-Automated Urinalysis System
Manufacturer
ARKRAY, Inc.
Date Cleared
2016-10-07

(269 days)

Product Code
JIL,CDM,CEN,JIN,JIO,JIR,JJB,JMT,JRE,KQO,LJX
Regulation Number
862.1340
Type
Traditional
Panel
CH
Reference & Predicate Devices
k030600,K093098
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The AUTION ELEVEN Semi-Automated Urinalysis System provides a qualitative and semi-quantitative measurements for glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrites, leukocytes, specific gravity and color tone in urine specimens. The system is intended for in vitro diagnostic use in screening patient populations found in clinical laboratories.

The AUTION ELEVEN Semi-Automated Urinalysis System consists of the following:

  • · AUTION ELEVEN model AE-4022 Urine Analyzer (device component)
  • · AUTION Sticks 10EA Test Strips (reagent component)
Device Description

The AUTION ELEVEN Semi-Automated Urinalysis System provides a qualitative and semi-quantitative measurement for glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrites, leukocytes, specific gravity and color tone. The system is intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The AUTION ELEVEN Semi-Automated Urinalysis System consists of AUTION ELEVEN model AE-4022 urine analyzer and AUTION Sticks 10EA test strips.

The AUTION sticks 10EA consist of a plastic strip containing 10 pads impregnated with chemicals specific for the determination of a particular analyte. The chemical reaction with the urine results in a color change which is measured by the AUTION ELEVEN AE-4022 device, resulting in a display and print out indicating analyte concentration. The AUTION ELEVEN technology provides fast results that can be used along with other diagnostic information to rule out certain disease states and to determine if microscopic analysis is needed.

The semi-automated nature of the device requires the user to dip an AUTION Stick 10EA test strip into a patient urine specimen and place it on the instrument. The instrument processes the test strip, allowing 60 seconds for the chemical reactions to occur on the test strip reagent pads. After 60 seconds, the device measures the amount of reflectance generated from each reagent pad and converts the reflectance measurements to qualitative and semi-quantitative results for physician use.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the AUTION ELEVEN Semi-Automated Urinalysis System, extracted from the provided text:

Acceptance Criteria and Device Performance

Precision Results

AnalyteAcceptance Criteria (Exact match%)Reported Device Performance (Exact match%)Acceptance Criteria (+/- 1 Color Block%)Reported Device Performance (+/- 1 Color Block%)
GlucoseNot explicitly stated98% (Repeatability), 99% (Reproducibility)Not explicitly stated100% (Repeatability), 100% (Reproducibility)
ProteinNot explicitly stated100% (Repeatability), 100% (Reproducibility)Not explicitly stated100% (Repeatability), 100% (Reproducibility)
BilirubinNot explicitly stated99% (Repeatability), 99% (Reproducibility)Not explicitly stated100% (Repeatability), 100% (Reproducibility)
UrobilinogenNot explicitly stated99% (Repeatability), 100% (Reproducibility)Not explicitly stated100% (Repeatability), 100% (Reproducibility)
pHNot explicitly stated98% (Repeatability), 99% (Reproducibility)Not explicitly stated100% (Repeatability), 100% (Reproducibility)
Specific GravityNot explicitly stated96% (Repeatability), 97% (Reproducibility)Not explicitly stated100% (Repeatability), 100% (Reproducibility)
BloodNot explicitly stated99% (Repeatability), 100% (Reproducibility)Not explicitly stated100% (Repeatability), 100% (Reproducibility)
KetonesNot explicitly stated100% (Repeatability), 100% (Reproducibility)Not explicitly stated100% (Repeatability), 100% (Reproducibility)
NitriteNot explicitly stated100% (Repeatability), 100% (Reproducibility)Not explicitly stated100% (Repeatability), 100% (Reproducibility)
LeukocytesNot explicitly stated100% (Repeatability), 100% (Reproducibility)Not explicitly stated100% (Repeatability), 100% (Reproducibility)

Note: The document states that "results from bench testing met pre-determined acceptance criteria and support a determination of substantial equivalence." However, the specific numerical acceptance criteria for "Exact match %" and "+/- 1 Color Block %" were not explicitly listed in the tables provided for precision. The reported device performance values are the results obtained from the study.

Method Comparison Results (Accuracy)

AnalyteAcceptance Criteria (Exact Agreement with Predicate)Reported Device Performance (Exact Agreement with Predicate)Acceptance Criteria (Agreement within ± 1 color block)Reported Device Performance (Agreement within ± 1 color block)
GlucoseNot explicitly stated98%Not explicitly stated100%
ProteinNot explicitly stated86%Not explicitly stated100%
BilirubinNot explicitly stated100%Not explicitly stated100%
UrobilinogenNot explicitly stated98%Not explicitly stated100%
pHNot explicitly stated89%Not explicitly stated100%
Specific GravityNot explicitly stated81%Not explicitly stated99%
BloodNot explicitly stated92%Not explicitly stated100%
KetonesNot explicitly stated96%Not explicitly stated100%
NitriteNot explicitly stated99%Not explicitly stated100%
LeukocyteNot explicitly stated92%Not explicitly stated100%

Note: Similar to precision, the document states "The overall conclusion from the clinical evaluation is that the results are acceptable and support a determination of substantial equivalence," implying the reported accuracy rates met their internal acceptance criteria. However, the specific numerical acceptance thresholds were not provided in these tables.

Detection Limits/Sensitivity Results

The acceptance criteria here are that the "Actual Concentration" for a given semi-quantitative rank should result in the device reporting that rank (or a higher rank) at a certain "Percent in Rank." These are implicitly the acceptance criteria for sensitivity. The table shows the "Actual Concentration" and the "Percent in Rank" achieved. For instance, for Glucose, the acceptance criterion for the 4+ rank might be that at 750 mg/dL, it should be in the 4+ rank at least 50% of the time (reported 87%).

Interfering Substances

The acceptance criteria are implicitly that the identified interferents cause a specific shift in color blocks as described (e.g., False negative (-2 to -3 color block change) for Glucose with Ascorbic acid). The study identifies what interference occurs and its magnitude, implying these findings were deemed acceptable within the context of device labeling.

Study Details

  1. Sample size used for the test set and the data provenance:

    • Precision Study:
      • Sample Size: Not a direct patient sample size. Three (3) levels of quality controls were used for each analyte.
      • Data Provenance: Not specified, but likely controlled laboratory conditions given the use of commercial controls and specified dilutions/spiking.
    • Method Comparison Study (Accuracy):
      • Sample Size: 8395 tests of individual analytes. The number of unique patient samples is not explicitly stated, but the note mentions "Each site collected urine patient samples from their clinical laboratory or obtained them from nearby hospitals."
      • Data Provenance: Clinical patient samples, collected and refrigerated within 2 hours of collection for up to 24 hours prior to testing. Country of origin is not specified, but the clinical sites suggest real-world data collection. The study is prospective in the sense that samples were collected for the purpose of this study.

  2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

    • Precision Study: Not applicable. Ground truth was established by the known concentrations of the quality control materials.
    • Method Comparison Study: Ground truth was established by comparison against "2 commercially available urinalysis predicates, 1 semi-automated urine analyzer was used for specific gravity comparison and one fully-automated urine analyzer was used to compare all the rest of the analytes." No human experts were explicitly mentioned for ground truth establishment for this comparison. The predicate devices served as the reference standard.

  3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

    • Not applicable for either the precision or method comparison studies as ground truth was established either by known control concentrations or by predicate device performance, not by human expert consensus requiring adjudication.

  4. 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device is an automated and semi-automated urinalysis system, and the studies focused on its analytical performance against predicate devices and known controls, not on human reader performance or AI assistance.

  5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

    • Yes, the performance characteristics studies (Precision, Method Comparison, Detection Limits, Interfering Substances) represent standalone (algorithm only) performance of the AUTION ELEVEN Semi-Automated Urinalysis System. While a human dips the strip, the measurement and interpretation of the color change are performed by the automated device's optical unit and algorithms. The system then provides qualitative and semi-quantitative results automatically.

  6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

    • Precision Study: Known concentrations of quality control materials.
    • Method Comparison Study: Comparison against established predicate urinalysis devices for each analyte.

  7. The sample size for the training set:

    • No information about a "training set" is provided in the document. This type of device (urinalysis analyzer) is typically developed and validated using analytical samples (spiked, diluted, known concentrations) and clinical samples, rather than a machine learning "training set" in the conventional sense. The "Performance Characteristics" section details the validation of the device's measurement accuracy and precision.

  8. How the ground truth for the training set was established:

    • Not applicable, as no training set was explicitly mentioned or described for this type of device validation.

§ 862.1340 Urinary glucose (nonquantitative) test system.

(a)
Identification. A urinary glucose (nonquantitative) test system is a device intended to measure glucosuria (glucose in urine). Urinary glucose (nonquantitative) measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia.(b)
Classification. Class II.