Search Results

Panel

Multi-Lancet Device 2, ReliOn Premier Lancing Device

Reference & Predicate Devices

K093098,K013783

Intended Use

The AUTION MAX AX-4060 Urinalysis System (AUTION MAX) is comprised of the AUTION MAX AX-4060 automated urine analyzer and AUTION Sticks 9EB multi-parameter test strips.

The AUTION MAX AX-4060 urine analyzer, when used with AUTION Sticks 9EB test strips is a fully automated urinalysis system intended for the in vitro qualitative or semi-quantitative measurement of the following analytes: glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrite, leukocytes, turbidity, and color. The test results of these parameters can be used in the evaluation of kidney, urinary, liver and other metabolic disorders. This system is intended to be used by trained operators in clinical laboratories.

AUTION Sticks 9EB test strips are test strips for the in vitro qualitative or semi-quantitative measurement of the following analytes: glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrite, and leukocytes with the AUTION MAX AX-4060 urine analyzer. The test results of these parameters can be used in the evaluation of kidney, urinary, liver and other metabolic disorders.

Special conditions for use statements: Prescription use only. AUTION Sticks 9EB test strips are not to be read visually.

Device Description

The AUTION MAX AX-4060 Urinalysis System is a fully automated urine analyzer that provides a semi-quantitative or qualitative measurement for glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrites, leukocytes, specific gravity, turbidity, and color tone. The AUTION MAX AX-4060 Urinalysis System consists of AUTION MAX AX-4060 urine analyzer and AUTION Sticks 9EB test strips.

The AUTION Sticks 9EB test strips consist of a plastic strip containing 9 dry chemistry reagent pads impregnated with chemical substances for the determination of the above analytes in urine. These substances if present in urine leads to a chemical reaction that results in a color change, which is measured by the AUTION MAX AX-4060 urine analyzer based on spectrophotometry. In addition, three additional parameters, specific gravity, turbidity, and color tone are directly measured based on reflectance refractometry, transmitted and scattered light measurements.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) summary:

Device: AUTION MAX AX-4060 Urinalysis System
Predicate Device: AUTION MAX AX-4030 Fully Automated Urinalysis System

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as distinct numerical targets in the document. Instead, the study aims to demonstrate substantial equivalence to the predicate device. Therefore, the "acceptance criteria" are implicitly understood as matching or performing comparably to the predicate device's established performance, particularly in terms of agreement percentage. The reported device performance is presented as the agreement between the proposed device (AUTION MAX AX-4060) and the predicate device (AUTION MAX AX-4030).

Key Performance Metric: Percentage of Exact Match and Percentage within +/- 1 Color Block Match compared to the predicate device.

Analyte	Acceptance Criteria (Implicit: Substantial Equivalence to Predicate)	Reported Device Performance (Exact Match %)	Reported Device Performance (+/- 1 CB Match %)
GLU	High agreement (Exact and +/- 1 CB match)	98.1%	100.0%
PRO	High agreement (Exact and +/- 1 CB match)	94.5%	100.0%
BIL	High agreement (Exact and +/- 1 CB match)	99.5%	100.0%
URO	High agreement (Exact and +/- 1 CB match)	99.2%	100.0%
pH	High agreement (Exact and +/- 1 CB match)	92.9%	100.0%
BLD	High agreement (Exact and +/- 1 CB match)	95.8%	100.0%
KET	High agreement (Exact and +/- 1 CB match)	99.0%	100.0%
NIT	High agreement (Exact and +/- 1 CB match)	99.7%	100.0%
LEU	High agreement (Exact and +/- 1 CB match)	98.6%	100.0%
Turbidity	High agreement (Exact and +/- 1 CB match)	98.6%	100.0%
Color tone	High agreement (Exact and +/- 1 CB match)	82.7%	100.0%

(Note: The +/- 1 CB Match indicates results falling within one color block difference from the predicate, which is often considered acceptable for semi-quantitative tests.)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set (Method Comparison): A total of 1374 samples were used. This included:
- 1333 natural patient samples
- 41 spiked samples
Data Provenance: The study was conducted at two (2) clinical laboratories. The document does not specify the country of origin, but given the FDA submission, it's likely conducted in or in accordance with standards for the U.S. and/or Japan (where the manufacturer is located). It is a prospective comparison study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This study does not involve human experts establishing a "ground truth" for each sample in the typical sense of diagnostic imaging or pathology. Instead, the "ground truth" for the method comparison study is the result obtained from the legally marketed predicate device (AUTION MAX AX-4030 Automated Urinalysis System). The study demonstrates the correlation and agreement of the new device's readings with the predicate device's readings. No information is provided about experts interpreting results aside from the automated systems.

4. Adjudication Method for the Test Set

Since the "ground truth" is established by the predicate device's results and the comparison is between two automated systems, there was no human adjudication process (e.g., 2+1, 3+1 consensus) described for the test set.

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

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This study evaluates the performance of an automated urinalysis system against a predicate automated system, not the improvement of human readers with AI assistance.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

Yes. The primary study detailed, especially the Method Comparison (Section 14), assesses the standalone performance of the AUTION MAX AX-4060 Urinalysis System. It compares the results generated by the new automated system directly against those generated by the predicate automated system, without human intervention in the result interpretation or decision-making process during the comparison phase. The device itself is an automated system intended to be used by trained operators in clinical laboratories, but the performance data presented is for the automated analyzer's output.

7. Type of Ground Truth Used

The ground truth for the method comparison study was the results obtained from the legally marketed predicate device (AUTION MAX AX-4030 Automated Urinalysis System). For the initial precision study (Tables 3-5), the "Expected Result" for quality controls served as the reference.

8. Sample Size for the Training Set

The document is a 510(k) summary for a medical device (urinalysis system), not a typically "AI-driven" software device that undergoes explicit training. The device determines analytes based on chemical reactions and spectrophotometry (reflectance refractometry, transmitted and scattered light measurements). Therefore, there is no explicit "training set" in the context of machine learning algorithms usually discussed. The system is likely calibrated and validated during its development, but this is a different process than training an AI model.

9. How the Ground Truth for the Training Set Was Established

As noted above, there is no explicit "training set" in the machine learning sense for this device. The chemical principles and measurement methods are well-established for urinalysis. Any calibration or internal development would have relied on known concentrations and reference methods for each analyte to ensure accurate colorimetric or other measurements. The basis of the technology relates to established chemical reactions on the test pads (e.g., Glucose oxidase reaction for glucose, Protein-error reaction for protein, etc.).

Ask a Question

Ask a specific question about this device

K Number

K221175

Device Name

Manufacturer

Arkray, Inc.

Date Cleared

2022-10-17

(175 days)

Product Code

QRL

Regulation Number

878.4850

Type

General & Plastic Surgery

Panel

Reference & Predicate Devices

K120759,K214022

Intended Use

The Multi-Lancet Device 2 and ReliOn Premier Lancing Device are reusable lancing devices intended to be used with sterile, single-use compatible lancet blades to obtain a capillary blood sample from the fingertip or alternate sites for blood glucose testing or other tests that require small amounts of blood. The Multi-Lancet Device 2 and ReliOn Premier Lancing Device are intended for single person use only.

Device Description

The Multi-Lancet Device 2 and ReliOn Premier Lancing Device are used with a compatible single-use lancet to puncture the skin and release a small amount of blood. The products are distributed individually or packaged together with blood glucose monitoring systems to obtain capillary whole blood samples required for testing blood glucose levels.

AI/ML Overview

The provided text is an FDA 510(k) premarket notification approval letter for a Multi-Lancet Device 2 and ReliOn Premier Lancing Device. It focuses on demonstrating substantial equivalence to a predicate device (Accu-Chek Softclix Blood Lancing System) through comparisons of intended use, technological characteristics, and non-clinical performance testing.

Crucially, this document focuses on a medical device (lancing device) and not an AI/ML-driven medical device. Therefore, a significant portion of the requested information, such as "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone algorithm performance," "training set size," and "how ground truth for training set was established," are not applicable to the information provided.

The document primarily describes the physical device and its mechanical and safety performance, not the performance of an AI algorithm.

Here's a breakdown of the available information based on your request, noting where information is not applicable (N/A) due to the nature of the device:

1. A table of acceptance criteria and the reported device performance

The document mentions "Non-Clinical bench testing was performed per the special controls (878.4850). Cleaning/Disinfecting and Mechanical Robustness verification testing was completed to ensure the safety and usability for the duration of the claimed service life." It also states, "Performance testing on the proposed Multi-Lancet Device 2 and ReliOn Premier Lancing Device demonstrate that the devices meet the performance requirements for their intended use."

However, specific numerical acceptance criteria (e.g., maximum allowed force for puncture, minimum number of uses before failure) and the reported device performance against these criteria are not detailed in this public FDA letter. The letter only confirms that such testing was done and met the requirements.

Table of Acceptance Criteria and Reported Device Performance (Based on provided text)

Category	Acceptance Criteria (Stated or Implied)	Reported Device Performance
Safety & Usability	Ensure safety and usability for the duration of the claimed service life, addressing all identified risks.	"Non-Clinical bench testing was performed per the special controls (878.4850). Cleaning/Disinfecting and Mechanical Robustness verification testing was completed to ensure the safety and usability for the duration of the claimed service life. The risk analysis contained in the Risk Management Report confirms that all identified risks were addressed and mitigated appropriately. All residual risks after mitigation were acceptable and communicated in the instructions for use."
Performance	Meet performance requirements for their intended use.	"Performance testing on the proposed Multi-Lancet Device 2 and ReliOn Premier Lancing Device demonstrate that the devices meet the performance requirements for their intended use."
Labeling	Adequately communicate intended use, safety precautions, and directions for use, meeting 21 CFR § 801 and 21 CFR 878.4850 (c)(vi).	"Labeling adequately communicates to the user the device intended use, safety precautions and directions for use. The labeling meets the requirements documented in the: 1. Regulation for Medical Device Labeling (21 CFR § 801) 2. Regulation for multiple use blood lancet for single patient use only (21 CFR 878.4850 (c)(vi))"
Substantial Equivalence	Demonstrate substantial equivalence to predicate device based on classifications, intended use, and technological characteristics.	"The Multi-Lancet Device 2 and ReliOn Premier Lancing Device are substantially equivalent to the predicate Accu-Chek Softclix Lancing Device based on comparisons of the device classifications, intended use, and technological characteristics. Non-clinical performance testing successfully confirmed the suitability of the Multi-Lancet Device 2 and ReliOn Premier Lancing Device for the intended uses and demonstrated the devices are as safe, as effective, and perform as well as the predicate device as required per 21 CFR § 807.92(b)(3)."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "Non-Clinical bench testing." This typically involves laboratory testing of the physical device rather than a "test set" of clinical data (like medical images). The sample size for these bench tests is not specified, nor is the "data provenance" as it's not a clinical data study. The applicant's address is ARKRAY Factory, Inc., 1480 Koji, Konan-cho, Koka-shi, Shiga 520-3306 Japan, suggesting the company is based in Japan, but this doesn't explicitly state the location of the bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is a mechanical lancing device, not an AI/ML-driven diagnostic tool that requires ground truth established by experts interpreting data (e.g., radiologists interpreting images). The "ground truth" for this device relates to its mechanical performance and safety, verified through specified testing protocols.

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

Not applicable. There is no "test set" of patient data that would require an adjudication method.

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 is not an AI/ML device, and no MRMC study would be conducted. The "assistance" provided by this device is mechanical (blood sampling), not interpretative or cognitive.

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

Not applicable. This is a mechanical device, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance, as implied, is established by bench test standards and regulatory requirements (e.g., 21 CFR 878.4850 special controls) regarding mechanical robustness, cleaning/disinfection effectiveness, and general safety. It's not a "truth" derived from clinical data like pathology or expert consensus.

8. The sample size for the training set

Not applicable. As this is not an AI/ML device, there is no "training set."

9. How the ground truth for the training set was established

Not applicable. As this is not an AI/ML device, there is no "training set" or corresponding ground truth establishment method.

Ask a Question

Ask a specific question about this device

K Number

K200788

Device Name

Assure Titanium Blood Glucose Monitoring System

Manufacturer

Arkray, Inc.

Date Cleared

2022-05-23

(788 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K132121

Intended Use

The Assure Titanium Blood Glucose Monitoring System consists of the Assure Titanium Blood Glucose meter and the Assure Titanium Blood Glucose test strips. The Assure Titanium Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The system is intended for in vitro diagnostic, point of care use in endocrinology clinics and nursing facilities, for multiple patient use. This system should only be use, auto-disabling lancing devices for drawing finger stick capillary blood.

The system is not intended for the screening or diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia.

The system is not intended for use in acute care or hospital settings.

The system is not intended for neonatal use.

The system is for prescription use only.

Device Description

The Assure Titanium Blood Glucose Monitoring System consists of a battery-powered meter, disposable test strips Assure Titanium Blood Glucose Test Strips, and control solutions. The Assure Titanium Blood Glucose Test Strips utilizes biosensor technology for the quantitative determination of glucose concentrations in capillary blood samples. Glucose in the blood reacts with the reagent in the test strip, and this produces a small electric current (amperometry). The strength of this current is proportional to the concentration of glucose in the blood. The meter measures this current and calculates the patient's glucose level.

AI/ML Overview

The Assure® Titanium Blood Glucose Monitoring System underwent extensive performance testing to demonstrate its safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance:

Test Category	Acceptance Criteria	Reported Device Performance
Precision	Within-run Precision: %CV ≤ 4.2%	Within-run Precision: Met %CV ≤ 4.2% across all glucose levels (30-400 mg/dL) and all three test strip lots. For example, for Lot 280-2, %CV ranged from 2.1% to 3.1%. For Lot 280-4, %CV ranged from 1.9% to 2.9%. For Lot 280-5, %CV ranged from 2.3% to 2.7%.
	Intermediate Precision: Not explicitly stated with a numerical criterion in the document for all levels, but the document states "Intermediate precision met the overall acceptance criteria."	Intermediate Precision: All Lots Combined results showed %CV ranging from 1.4% to 2.1% across glucose levels from 30-400 mg/dL.
Linearity	All measurements to fall within ±15% at 600 mg/dL.	Error Codes for Samples Outside Measuring Range: All results met the acceptance criteria, displaying "Lo" for 600 mg/dL.
Error Codes and Flagging	For each error code/flag, the appropriate conditions must trigger it, and conditions that should not trigger it must not.	Error Codes and Flagging: For each error code/flag listed (E-1 to E-10, E6, E5, E0, Control Solution Flag, Temperature Flag), the appropriate conditions triggered the error, and non-triggering conditions did not, verifying proper functionality.
Short Sample Detection	The system should either produce an error or an accurate result when a short sample is applied.	Short Sample Detection: The system demonstrated it will either produce an error or an accurate result when short sampled (using sample volumes from 0.1 to 10 uL).
Sample Perturbation	The system should either provide an error or an accurate result when the sample is perturbed.	Sample Perturbation: The system demonstrated it would either provide an error or an accurate result when the sample was perturbed (by flicking the test strip, flipping the meter, or wicking the sample away).
Testing with Used Test Strip	All used test strips shall produce the E1 error upon re-insertion, and no glucose measurement results should be provided.	Testing with Used Test Strip: All test results met the acceptance criteria, producing the E1 error upon re-insertion of used test strips.
Clinical Accuracy (Method Comparison)	Nursing/Skilled Nursing Facility: 300 mg/dL:** 100% within ±20%.	Accuracy at Extremes: 300 mg/dL: 100% (50/50) within ±12%, ±15%, and ±20% (92% within ±10%, 64% within ±5%).
Usability	Positive feedback on ease of use and understanding of the system and manuals.	Usability: 100% of POC operators provided positive feedback (Very Easy, or OK) on the ease of use of the blood glucose meter system and the user manual/quick reference guide.

2. Sample Size Used for the Test Set and the Data Provenance:

Precision (Within-run): 1500 tests (500 results on each of 3 lots)
Precision (Intermediate): 1500 tests (50 tests per lot per day over 10 days for 3 lots)
Linearity: 165 results (5 replicates per level for 11 glucose concentrations, across 3 test strip lots)
Clinical Accuracy (Method Comparison): Capillary blood samples from 396 patients were measured.
- Site #1 (Nursing/Skilled Nursing Facility): 130 patients
- Site #2 (Endocrinology Clinic, California): 165 patients
- Site #3 (Endocrinology Clinic, Georgia): 101 patients
Accuracy at Extremes: 100 samples (50 samples 300 mg/dL).

The provenance for precision, linearity, hematocrit, and interference studies appears to be laboratory-controlled (venous whole blood spiked or glycolyzed). The clinical study data provenance is prospective, collected in the United States (Massachusetts, California, Georgia) at one nursing/skilled nursing facility and two endocrinology clinics.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

The document mentions that the YSI Model 2300 Glucose Analyzer was used as the reference standard (comparator method) for establishing ground truth in the linearity, clinical accuracy, and accuracy at extremes studies. The YSI 2300 is a laboratory instrument, not a human expert. Therefore, no human experts were used to establish the ground truth for these quantitative measurements.

For the usability study, "POC operators" were involved in evaluating the system, but they weren't establishing a "ground truth" for glucose levels. Their qualifications are not specified beyond being "Point-of-Care operators."

4. Adjudication Method for the Test Set:

Not applicable, as the ground truth for glucose measurements was established by a laboratory reference instrument (YSI 2300), not through expert consensus requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This device is a Blood Glucose Monitoring System, and its performance is evaluated by comparing its readings directly to a laboratory reference standard (YSI 2300), not by assessing how human readers improve with AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Yes, the core performance studies (precision, linearity, hematocrit, interference, environmental, altitude, error codes, short sample detection, sample perturbation, used test strip detection) evaluate the standalone performance of the Assure® Titanium Blood Glucose Monitoring System (meter and test strips) by comparing its output directly to a reference method or evaluating built-in error detection mechanisms.

The clinical accuracy study also compares the device's measurements (obtained by POC operators, but the measurement itself is algorithmic) against the YSI 2300 reference, effectively demonstrating its standalone accuracy in a clinical setting.

7. The Type of Ground Truth Used:

The primary ground truth used for quantitative glucose measurements was reference laboratory method data, specifically from the YSI Model 2300 Glucose Analyzer.

8. The Sample Size for the Training Set:

The document does not specify a separate "training set" or its size. This is typical for a medical device cleared via a 510(k) pathway, especially for a blood glucose monitoring system, where development often involves calibration and verification/validation against reference methods rather than supervised machine learning model training.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as a separate training set and its ground truth establishment are not discussed in the provided submission. The device's underlying principles (electrochemical biosensor) are well-established, and its "training" or calibration would typically be an inherent part of its manufacturing process, verified through performance testing against reference standards as described.

Ask a Question

Ask a specific question about this device

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

Panel

AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROL

Reference & Predicate Devices

k030600,K093098

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

Analyte	Acceptance Criteria (Exact match%)	Reported Device Performance (Exact match%)	Acceptance Criteria (+/- 1 Color Block%)	Reported Device Performance (+/- 1 Color Block%)
Glucose	Not explicitly stated	98% (Repeatability), 99% (Reproducibility)	Not explicitly stated	100% (Repeatability), 100% (Reproducibility)
Protein	Not explicitly stated	100% (Repeatability), 100% (Reproducibility)	Not explicitly stated	100% (Repeatability), 100% (Reproducibility)
Bilirubin	Not explicitly stated	99% (Repeatability), 99% (Reproducibility)	Not explicitly stated	100% (Repeatability), 100% (Reproducibility)
Urobilinogen	Not explicitly stated	99% (Repeatability), 100% (Reproducibility)	Not explicitly stated	100% (Repeatability), 100% (Reproducibility)
pH	Not explicitly stated	98% (Repeatability), 99% (Reproducibility)	Not explicitly stated	100% (Repeatability), 100% (Reproducibility)
Specific Gravity	Not explicitly stated	96% (Repeatability), 97% (Reproducibility)	Not explicitly stated	100% (Repeatability), 100% (Reproducibility)
Blood	Not explicitly stated	99% (Repeatability), 100% (Reproducibility)	Not explicitly stated	100% (Repeatability), 100% (Reproducibility)
Ketones	Not explicitly stated	100% (Repeatability), 100% (Reproducibility)	Not explicitly stated	100% (Repeatability), 100% (Reproducibility)
Nitrite	Not explicitly stated	100% (Repeatability), 100% (Reproducibility)	Not explicitly stated	100% (Repeatability), 100% (Reproducibility)
Leukocytes	Not explicitly stated	100% (Repeatability), 100% (Reproducibility)	Not explicitly stated	100% (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)

Analyte	Acceptance 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)
Glucose	Not explicitly stated	98%	Not explicitly stated	100%
Protein	Not explicitly stated	86%	Not explicitly stated	100%
Bilirubin	Not explicitly stated	100%	Not explicitly stated	100%
Urobilinogen	Not explicitly stated	98%	Not explicitly stated	100%
pH	Not explicitly stated	89%	Not explicitly stated	100%
Specific Gravity	Not explicitly stated	81%	Not explicitly stated	99%
Blood	Not explicitly stated	92%	Not explicitly stated	100%
Ketones	Not explicitly stated	96%	Not explicitly stated	100%
Nitrite	Not explicitly stated	99%	Not explicitly stated	100%
Leukocyte	Not explicitly stated	92%	Not explicitly stated	100%

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

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.
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.
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.
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.
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.
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.
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.
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.

Ask a Question

Ask a specific question about this device

K Number

K121456

Device Name

Manufacturer

Date Cleared

2013-02-01

(261 days)

Product Code

KQO,CDM,CEN,JIL,JIN,JIO,JIR,JJB,JJW,JMT,JRE,LJX,LKM

Regulation Number

862.2900

Type

Panel

AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM

Reference & Predicate Devices

k093098,k080887,k070910

Intended Use

The AUTION HYBRID™ AU-4050 Fully Automated Integrated Urine Analyzer System contains a test strip chemistry urine analyzer and a flow cytometry urine particle analyzer together in a single integrated device. The test strip chemistry module (CHM) is an automated urine analyzer intended for the in vitro measurement of the following parameters: glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrite, leukocytes, specific gravity, turbidity, and color. The chemistry module is intended for use with the Uriflet™ S 9HA multi-parameter urine chemistry test strips. The flow cytometry module (FCM) is an automated urine particle analyzer intended to analyze the following parameters in urine samples: Red Blood Cells, White Blood Cells, Epithelial Cells, Casts, and Bacteria and flags the presence of the following: Pathologic Casts, Crystals, Sperm, Small Round Cells, Yeast Like Cells, and Mucus. The AUTION HYBRID AU-4050 is intended for in vitro diagnostic use in screening patient populations found in clinical laboratories.

Uriflet™ S 9HA is a urinalysis test strip with reagent pads for the determination of Glucose, Protein, Bilirubin, Urobilinogen, pH, Blood, Ketones, Nitrite, and Leukocytes. Uriflet S 9HA is for use with the AUTION HYBRID AU-4050 only.

The AUTION Control Solution is intended for in vitro diagnostic use only for performing quality control procedures with the AUTION HYBRID AU-4050 flow cytometry module.

Device Description

The AUTION HYBRID AU-4050 is a fully automated urine analysis system. The AU-4050 contains a test strip chemistry urine analyzer also called the chemistry module (CHM) and a flow cytometry urine particle analyzer also called the flow cytometry module (FCM) together in a single integrated device. The CHM module analyzes the following parameters in urine: glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrite, leukocytes, specific gravity, turbidity, and color. The FCM module measures the following parameters in urine utilizing flow cytometry technology: Red Blood Cells. White Blood Cells. Epithelial Cells, Casts, and Bacteria. The FCM module flags for the presence of the following: Pathologic Casts, Crystals, Sperm, Small Round Cells. Yeast Like Cells and Mucus.

AI/ML Overview

The provided document is a 510(k) summary for the ARKRAY AUTION HYBRID AU-4050 Fully Automated Integrated Urine Analyzer System, Uriflet™ S 9HA Urine Test Strips, and AUTION Control Solution. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results with specific acceptance criteria and performance metrics in the way a novel device might.

Therefore, the information typically requested in your prompt regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment is not explicitly detailed in this 510(k) summary. The document emphasizes comparison to predicate devices and states that "Clinical and bench testing was used to verify the performance characteristics of this device. This testing showed acceptable device performance that is substantially equivalent to the performance of the predicate devices."

However, I can extract the available information and also highlight what is not present in the document.

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria or specific reported device performance metrics in a table format for the new device against predefined thresholds. Instead, it relies on demonstrating substantial equivalence to existing predicate devices (AUTION MAX AX-4030 Urinalysis System (K093098), SYSMEX UF1000i Automated Urine Particle Analyzer with Urinalysis WAM software (K080887), and Sysmex UF-II Control (K070910)).

The "performance" demonstration is primarily through comparison of technological characteristics, intended use, operating principles, and design features to the predicate devices. The assumption is that since the predicate devices are already cleared, demonstrating equivalence implies acceptable performance.

Here's a summary of the comparisons provided, which implicitly serve as performance benchmarks by virtue of their equivalence:

Category	AUTION MAX AX-4030 (Predicate Device - Chemistry Module)	AUTION HYBRID AU-4050 (Proposed Device - Chemistry Module)
Intended Use	Automated urine chemistry analyzer	Same
Sample Type	Human Urine	Same
Measurement Wavelength	430, 500, 565, 635, 760 nm	Same
Measurement Method	SpectrophotOMETRY Test Strip: Dual-wavelength reflectance measurement (Single wavelength for BLD) S.G.: Reflection refractometry Color Tone: Light-transmission measurement Turbidity: Light-scattering measurement	Same
Measurement Items	GLU, PRO, BIL, URO, PH, BLD, KET, NIT, LEU, S.G, turbidity, and color-tone	Same
Test Strip Reaction Time	Approx. 60 seconds	Same as AX-4030

Category	SYSMEX UF-1000i (Predicate Device - Flow Cytometry Module)	AUTION HYBRID AU-4050 (Proposed Device - Flow Cytometry Module)
Intended Use	Automated urine particle analyzer	Same
Sample Type	Human Urine	Same
Measurement Method	Sysmex flow cytometry using a red semiconductor laser	Same
Measurement Items	RBC, WBC, Epithelial Cells, Cast, and Bacteria (flags for Pathologic Cast, Crystal, Sperm, Small Round Cell, Yeast like cell, and Mucus)	Same

Category	Sysmex UF-II Control (Predicate Device - Control Solution)	AUTION Control Solution (Proposed Device)
Intended Use	Quality control for urine particle analyzers	Same
Form	Liquid, ready to use	Same
Levels	2	Same
Storage Stability	2°C-10°C until expiration date	Same
Open Vial Stability	30 days at 2°C-10°C	Same
Matrix	Liquid matrix solution	Same
Analytes	Red Blood Cells, White Blood Cells, Epithelial Cells, Casts, and Bacteria	Same

Note: Changes in operational characteristics like "Processing Speed," "Sample Volume," "Display," "Built-in Printer," "Dimensions," and "Weight" are noted but are not considered performance criteria in the context of substantial equivalence for accuracy or clinical efficacy. The critical aspect for this type of submission is that these changes do not raise new questions of safety or effectiveness.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document states: "Clinical and bench testing was used to verify the performance characteristics of this device." However, it does not provide details on:

The specific sample sizes used for any test sets.
The provenance of the data (e.g., country of origin, retrospective or prospective nature of the studies).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the 510(k) summary. For in-vitro diagnostic devices like this, expert review for ground truth might involve clinical pathologists or laboratory professionals, but the document does not elaborate.

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

This information is not provided in the 510(k) summary.

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

The device is an automated urine analyzer, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers with/without AI assistance is not applicable and was not performed or referenced. The device performs the analysis automatically.

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

Yes, the device is inherently a standalone (algorithm only) device as it is a fully automated integrated urine analyzer system performing in vitro measurements. Its performance would be evaluated based on the accuracy and precision of its automated measurements against a reference method or predicate device, independent of direct real-time human interpretation assistance during the analysis. The "comparison to predicate devices" and "clinical and bench testing" mentioned constitute this standalone performance evaluation relative to known performance.

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

The document does not explicitly state the specific type of ground truth used. For IVD devices, "clinical and bench testing" typically refers to studies where:

Bench testing might involve spiked samples, controls, or samples with known concentrations/particle counts verified by confirmatory lab methods.
Clinical testing would involve patient samples, likely compared against a reference method (e.g., manual microscopy for urine sediment, or established clinical chemistry methods for parameters like glucose, protein) which would effectively serve as the ground truth. Since the application is for "in vitro diagnostic use in screening patient populations," the ground truth would likely be established by clinical laboratory standards and reference methods.

8. The sample size for the training set

This information is not provided in the 510(k) summary. The document describes a traditional automated analyzer, not a machine learning/AI device that typically employs distinct "training" datasets in the computational sense. Performance verification for this device involved "clinical and bench testing."

9. How the ground truth for the training set was established

As the document does not describe a "training set" in the context of machine learning, this information is not applicable/provided. For traditional IVD analyzers, ground truth for sample data used in method comparison or verification studies (analogous to validation) would be established by reference laboratory methods, sometimes using spiked samples or certified reference materials for precision and accuracy assessments.

Ask a Question

Ask a specific question about this device

K Number

K093098

Device Name

Manufacturer

Date Cleared

2009-12-23

(83 days)

Product Code

KQO,CDM,CEN,JIL,JIN,JIO,JIR,JJB,JMT,JRE,LJX

Regulation Number

862.2900

Type

Special

Panel

SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS

Reference & Predicate Devices

K013783

Intended Use

The AUTION MAX AX-4030 Urinalysis System (AUTION MAX) is an automated urine analyzer intended for the in vitro measurement of the following analytes: glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrite, leukocytes, specific gravity, turbidity, and color. The AUTION MAX is intended for use only with AUTION Sticks 9EB multi-parameter test strips.

Device Description

The AX-4030 device is composed of one main unit. A power cord provides the necessary electricity to run both the device and all of its components. The device is powered by the power cord which, itself, provides 100-200/200-240VAC with a frequency of 50-60Hz. The front of the main unit includes the LCD display screen and operator panel (top-center). In addition, there are several other features located along the bottom of the device including loading and u unloading sides for urine samples. One of the best features that the AX-4030 includes is a builtin printer that is located on top of the device.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the AUTION MAX AX-4030 Urinalysis System, extracted from the provided text.

The provided document is a 510(k) summary for the AUTION MAX AX-4030 Urinalysis System. This type of document focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results and acceptance criteria in the same way a typical medical device study report might. Therefore, some of the requested information (like specific acceptance criteria values, detailed study designs, and expert qualifications/adjudication) is not explicitly present in this regulatory filing.

However, based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Specific numerical acceptance criteria for each analyte are not explicitly detailed in this 510(k) summary. The document states "Non-clinical verification and validation testing was conducted on the AX-4030 device and the results of such testing appear in Section 18 of this submission." This indicates that detailed performance data exists, but it is not included in the publicly available summary provided.

For a device like this, acceptance criteria would typically be defined for parameters such as:

Accuracy/Correlation: Comparison of results to a reference method or predicate device results (e.g., % agreement, correlation coefficient).
Precision/Reproducibility: Repeatability and intermediate precision (e.g., coefficient of variation within acceptable limits).
Limit of Detection (LoD) / Limit of Quantitation (LoQ): The lowest concentration at which an analyte can be reliably detected/quantified.
Interference: Performance in the presence of common interferents in urine.
Carryover: Ensuring no significant contamination between samples.

Since these specific values are not in the provided text, a table cannot be fully constructed. The summary states that the results of non-clinical testing "appear in Section 18," indicating that the device met whatever acceptance criteria were established for those tests to support its substantial equivalence claim.

2. Sample Size for the Test Set and Data Provenance

Sample Size for Test Set: Not specified in the provided 510(k) summary. The document mentions "Non-clinical verification and validation testing," but does not detail the sample sizes used for this testing.
Data Provenance: Not specified in terms of country of origin for the test data, nor whether it was retrospective or prospective. It is implied to be internal verification and validation conducted by ARKRAY, Inc., likely involving various urine samples.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

Not applicable/provided. For an automated urinalysis system measuring defined analytes, "ground truth" is typically established by reference methods or validated laboratory techniques, not by human expert interpretation in the same way an imaging study would.

4. Adjudication Method for the Test Set

Not applicable/provided. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which is not the primary mode of operation for this automated system.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is not relevant for an automated urinalysis system like the AX-4030, which performs objective measurements of chemical analytes. This type of study is typically used for imaging diagnostics where human readers interpret images, often with and without AI assistance, to assess diagnostic performance.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, implicitly. The "Non-clinical verification and validation testing" described in the document as appearing in "Section 18" would constitute standalone performance testing of the device (its algorithms and hardware) without human intervention in the analysis process itself. The device is described as an "automated urine analyzer."

7. The Type of Ground Truth Used

The ground truth for an automated urinalysis system is typically established by:

Reference Laboratory Methods: Gold standard chemical assays for each analyte (e.g., enzymatic methods for glucose, turbidimetric methods for protein).
Gravimetric methods for specific gravity, etc.
Microscopic examination for correlation with certain parameters (e.g., blood, leukocytes, though the AX-4030 measures these chemically).
Predicate Device Comparison: Often, a key component of a 510(k) submission is demonstrating performance equivalent to a legally marketed predicate device.

The specific ground truth methods are not detailed in this summary but would be found in Section 18 of the original submission.

8. The Sample Size for the Training Set

Not specified. The 510(k) summary does not provide details about a training set, as this document focuses on the performance validation rather than the development of the algorithm itself. For a device that measures analytes using test strips, the "training" would primarily relate to calibration and ensuring the spectrophotometric readings accurately correlate with analyte concentrations, rather than machine learning training in the contemporary sense.

9. How the Ground Truth for the Training Set Was Established

Not specified. As mentioned above, the concept of a "training set" with established ground truth is less directly applicable in the sense of a machine learning model for image interpretation. For a chemical analyzer, ground truth for calibration and initial validation would involve using precisely prepared calibrators, controls, and known concentration samples analyzed by reference methods.

Ask a Question

Ask a specific question about this device

K Number

K053401

Device Name

Manufacturer

Date Cleared

2006-03-24

(108 days)

Product Code

CIC,CEK,CGA,CGX,CIX,JGZ

Regulation Number

862.1145

Type

Panel

SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID TESTS

Reference & Predicate Devices

N/A

Intended Use

The SPOTCHEM II Chemistry Basic 1 Calcium test is intended to measure the concentration of calcium in serum, plasma and whole blood. Serum calcum measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

The SPOTCHEM II Chemistry Basic 1 Blood Urea Nitrogen (BUN) test is intended to measure the concentration of urea nitrogen in serum, plasma and whole blood. Blood urea nitrogen measurements are used in the diagnosis and treatment of certain renal and metabolic diseases.

The SPOTCHEM II Chemistry Basic 1 Glucose test is intended to measure the glucose concentration in serum, plasma, and whole blood. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

The SPOTCHEM II Chemistry Basic 1 Albumin test is intended to measure the albumin concentration in serum, plasma, and whole blood. Measurements of albumin are used in the diagnosis and treatment of numerous diseases involving the liver or kidneys.

The SPOTCHEM II Chemistry Basic 1 Creatinine test is intended to measure the concentration of creatinine in serum, plasma, and whole blood. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

The SPOTCHEM II Chemistry Basic 2 ALP test is intended to measure ALP activity in serum, plasma, and whole blood. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.

The SPOTCHEM II Chemistry Basic 2 Total Bilirubin test is intended to measure the levels of bilirubin in serum, plasma, and whole blood. Measurements of the levels of bilirubin are used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.

The SPOTCHEM II Chemistry Basic 2 Total Protein test is intended to measure total protein in serum, plasma, and whole blood. Measurements of total protein are used in the diagnosis and treatment of a variety of diseases involving the liver, kidray, or oo ne marrow, as well as other metabolic and nutritional disorders.

The SPOTCHEM II Chemistry Basic 2 AST test is intended to measure AST activity in serum, plasma, and whole blood. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and head formants

The SPOTCHEM II Chemistry Basic 2 ALT test is intended to measure ALT activity in serum, plasma, and whole blood. Alanine amino transferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for the Arkray SPOTCHEM II Chemistry Basic 1 and Arkray SPOTCHEM II Chemistry Basic 2 devices, outlining their indications for use. It does not include details about acceptance criteria, specific study designs, sample sizes, expert qualifications, ground truth establishment, or comparative effectiveness studies.

Ask a Question

Ask a specific question about this device

K Number

K051648

Device Name

Manufacturer

SPOTCHEM II TOTAL BILIRUBIN, TOTAL PROTEIN AND ALBUMIN TESTS

Date Cleared

2006-01-31

(224 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Intended Use

Device Description

AI/ML Overview

Ask a Question

Ask a specific question about this device

K Number

K051432

Device Name

Manufacturer