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The On-Call® Plus Blood Glucose Monitoring System is an electrochemical enzymatic assay for the quantitative detection of glucose in capillary whole blood from the fingertip, forearm, and/or palm by people with diabetes at home and by healthcare professionals as an aid in the monitoring the effectiveness of diabetes control programs.

The On-Call® Plus Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus, nor intended for use on neonates.

The On-Call® Plus Blood Glucose control solution is for use with the On-Call® Plus Blood Glucose meter and strips as a quality control check to verify the accuracy of blood glucose test results.

The On-Call® Plus Blood Glucose Monitoring System is a quantitative assay for the detection of glucose in capillary whole blood sampled from the fingertip, palm, and/or forearm. The glucose, measurement is achieved by using the amperometric detection method.

The test strip has a reagent system including glucose oxidase and a mediator that reacts with glucose in the whole blood sample to produce an electrical current is measured by the meter, and after calculation by the meter, the blood glucose concentration reading is displayed on the meter display, calibrated to a plasma reference.

The provided text describes the "On-Call® Plus Blood Glucose Monitoring System" and its substantial equivalence to a predicate device, the "One Touch Ultra Blood Glucose Monitoring System". The information primarily focuses on non-clinical and clinical performance to establish this equivalence.

Here's an analysis of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The text explicitly mentions compliance with EN ISO 15197:2003 "In vitro diagnostic test systems - Requirements for in vitro whole blood glucose monitoring systems intended for use by patients for self testing in management of diabetes mellitus" as the primary standard for accuracy requirements. While the document states the device meets these accuracy requirements, it does not provide a direct table detailing the specific accuracy acceptance criteria from ISO 15197:2003 (e.g. percentage of readings within ±15% or ±20% of reference measurements) nor does it report specific performance metrics against these criteria.

However, it does list several performance characteristics that were evaluated:

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

The text states: "Clinical studies were conducted with lay persons and trained laboratory technicians using the On-Call® Plus Blood Glucose Monitoring System."

• Sample Size: The exact sample size for the clinical test set is not provided in the given text.
• Data Provenance: The text does not explicitly state the country of origin. It can be inferred that the studies were likely conducted in the US, given the submission is to the FDA and references US regulatory documents. The studies are prospective clinical studies involving both lay persons and trained technicians.

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

• Ground Truth Establishment: The ground truth for the clinical studies was established by comparison to the YSI Model 2300 STAT PLUS (K913806). The YSI is a commonly accepted laboratory reference method for glucose measurement.
• Number of Experts/Qualifications: The text mentions "trained laboratory technicians" used the predicate device, but it does not specify the number or specific qualifications (e.g., years of experience) of these technicians. The YSI machine itself serves as the reference, not human interpreters in this context.

4. Adjudication Method for the Test Set

Not applicable in the conventional sense for a blood glucose monitoring system. The accuracy is determined by direct comparison of the device's readings against a laboratory reference standard (YSI Model 2300 STAT PLUS), rather than human adjudication of interpretations.

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

• Was one done? No, a MRMC comparative effectiveness study was not done in the context of human readers improving with or without AI assistance. This device is a blood glucose meter, and the comparison is between the device's reading and a laboratory reference, not between human interpretations.
• Effect Size of Human Readers with/without AI: Not applicable, as there is no AI component for interpretation by human readers. The clinical study did compare readings obtained by "lay persons" (users at home) to "trained technicians" using the same device, but this isn't a human-reader-with-AI vs. human-reader-without-AI scenario. The conclusion was that lay persons obtained "comparable" readings.

6. Standalone (Algorithm Only) Performance

• Was one done? Yes, the entire evaluation of the "On-Call® Plus Blood Glucose Monitoring System" is a standalone performance evaluation of the device as an algorithm/system. The device itself (meter and test strip) is the "algorithm" that measures glucose. Its performance is directly compared to the YSI reference. The clinical study specifically assesses the device's ability to provide accurate readings on its own when used by both lay persons and professionals.

7. Type of Ground Truth Used

The type of ground truth used for the clinical performance evaluation was a laboratory reference method: the YSI Model 2300 STAT PLUS (K913806).

8. Sample Size for the Training Set

The text does not specify the sample size for any training set. Given the time period (2009) and the nature of the device (blood glucose meter), it is highly likely that empirical calibration and validation methods were used rather than a large-scale "training set" in the modern machine learning sense. The "laboratory testing" mentioned (linearity, precision, etc.) would have involved various samples to characterize the device's inherent performance.

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

As discussed above, the concept of a separate "training set" with ground truth in the AI/ML sense is not explicitly presented or likely for this device. The development and calibration of such a device generally involve using reference methods (like YSI) to establish the accuracy of the electrochemical enzymatic assay at various glucose concentrations, across different hematocrit levels, temperatures, etc. This would have involved numerous laboratory samples where the true glucose concentration was known through the reference method. However, the specific details or distinction between "training" and "testing" samples in this context are not provided in the document.

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The ACON Urinalysis Reagent Strips (Urine) are for qualitative and semi-quantitative detection of one or more of the following analytes in urine: Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, Leukocytes and Ascorbic Acid.

The ACON Urinalysis Reagent Strips (Urine) are for single use in professional nearpatient (point-of-care) and centralized laboratory locations. The strips are intended for use in screening at-risk patients to assist diagnosis in the following areas:

• Kidney function .
• Urinary track infections .
• Carbohydrate metabolism (e.g. diabetes mellitus) .
• Liver function .
• Acid-base balance .
• Urine concentration ●

The results can be used along with other diagnostic information to rule out certain disease states and to determine if microscopic analysis is needed. The test is to be read visually. It is intended for professional use only.

The ACON Urinalysis Reagent Strips are urine test strips of which Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocyte reagent pads are affixed onto the plastic strips. The reagent pads react with the urine and provide a visible color reaction. Results are obtained by direct comparison of the test strip with the color blocks printed on the bottle label. The product is packaged with a drying agent in a plastic bottle. The entire reagent strip is disposable when the disposal directions are followed exactly. Laboratory instrumentation is not required. These tests are intended for professional use with human urine.

The provided text describes the ACON Urinalysis Reagent Strips, their intended use, and a comparison to predicate devices, but it does not contain specific acceptance criteria, detailed study results, or information about sample sizes for training/test sets, ground truth establishment, expert qualifications, or MRMC studies.

Therefore, for aspects related to specific numerical acceptance criteria, detailed performance data, sample sizes, expert involvement, and comparative effectiveness studies, the information is not available in the provided document.

Here's an analysis of what information is available:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided document. The document states that "performance characteristics... were verified by sensitivity study, reproducibility study, interference studies, temperature flex study, and stability studies," but it does not specify the quantitative acceptance criteria for these studies or present the detailed reported performance values against such criteria.

The submission focuses on establishing substantial equivalence based on intended use, target population, specimen type, materials, storage, test time, and methodologies used, which are listed as "Same" as the predicate devices.

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

Not available in the provided document. The document mentions "clinical studies were conducted at Beta sites" but does not specify the sample size for these studies or the country of origin. It also does not explicitly state whether the data was retrospective or prospective.

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

Not available in the provided document. The document states the "test is to be read visually" and "intended for professional use only," implying human interpretation. However, it does not detail how ground truth was established for the clinical studies, nor if experts were involved, their number, or their qualifications.

4. Adjudication Method for the Test Set

Not available in the provided document. There is no mention of any adjudication method (e.g., 2+1, 3+1) used for the test set.

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

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or described. The document discusses "clinical accuracy of results" and "comparable testing data" between the ACON strips and predicate devices, which suggests an equivalence study rather than a comparative effectiveness study involving human readers with and without AI assistance (which is not relevant for this type of manual test).

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

Partially applicable, but not in the context of an algorithm. The device is a manual urinalysis reagent strip intended for visual reading by a professional. Therefore, the concept of an "algorithm only" or "standalone" performance study in the context of AI is not applicable. The device is the standalone test, and its performance is inherently tied to human interpretation of the visual reaction. The document does state that the test is "to be read visually" and "intended for professional use only."

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

Not explicitly stated for clinical studies. While the document describes the chemical reactions for each analyte (e.g., glucose, bilirubin, ketone, etc.), forming the basis of the test, it does not specify how the "ground truth" was established for the clinical studies used to compare the ACON strips to the predicate devices. For urinalysis, ground truth often involves laboratory reference methods, but this is not detailed here.

8. The Sample Size for the Training Set

Not applicable. The ACON Urinalysis Reagent Strips are a chemical test, not an AI/machine learning algorithm. Therefore, there is no "training set" in the computational sense. The product development would involve chemical optimization and validation, not model training.

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

Not applicable. As stated above, this is not an AI/machine learning device, so the concept of a training set and its ground truth establishment is not relevant.

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The ACON® Strep A Twist Rapid Test Device is a rapid chromatographic immunoassay for the qualitative detection of Strep A antigen from throat swab specimens to aid in the diagnosis of Group A Streptococcal infection. This test is indicated for professional and point of care use only.

The ACON® Strep A Twist Rapid Test Device is a qualitative, lateral flow immunochromatographic assay for the detection of Strep A antigen from a throat swab. The test is a heterogeneous, sandwich immunoassay, based on the principle of antigen-antibody immunochemistry, which uses a mixture of polyclonal antibodies to reliably produce a visually discernible colored line in the test region if Strep A antigen is present at a concentration of roughly 2.5 x 102 organisms per swab or greater.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Study Information:

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

   • Sample Size: 758 patient specimens.
   • Data Provenance: Multi-center clinical evaluation. The country of origin is not explicitly stated, but the sponsor is located in San Diego, California, suggesting a US-based study. It is a retrospective study, as specimens were collected from "patients presenting with signs and symptoms of pharyngitis."

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

   • The ground truth (Strep A confirmed culture technique) is a laboratory method, not established by human experts in the way a radiologist reads images. Therefore, the concept of "number of experts" and "qualifications of experts" does not directly apply to the primary ground truth methodology used for the clinical accuracy study.

3. Adjudication method for the test set:

   • Not specified. The study directly compared the ACON® Strep A Twist Rapid Test Device to a "commercially available Strep A test device" (QuickVue In-Line One-Step Strep A) and to "the customary Strep A confirmed culture technique." There is no mention of an adjudication process between different readers or interpretation of the index device.

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, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done. This device is a rapid diagnostic test for direct visualization of colored lines, not an AI-assisted interpretation device. The "multi-center" evaluation refers to where samples were collected, not to multiple human readers interpreting cases.

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

   • Yes, the performance data presented (Sensitivity, Specificity, Agreement) for the ACON® Strep A Twist Rapid Test Device are standalone performance metrics. While a human reads the colored lines, the device itself generates the result indicating presence or absence of Strep A. There isn't an "algorithm" per se in the way AI would be considered, but rather a biochemical reaction. The "standalone" here refers to the device's inherent ability to detect the antigen, which is then interpreted by a user.

6. The type of ground truth used:

   • Primary Ground Truth: Strep A confirmed culture technique. Culture is widely considered the gold standard for diagnosing Group A Streptococcal infection.
   • Secondary Comparison: Another commercially available Strep A test device (Quidel QuickVue In-Line One-Step Strep A) was used for agreement comparison.

7. The sample size for the training set:

   • The provided document does not explicitly mention a separate "training set" for the device's development. This is common for immunochromatographic assays where the device design and antibody selection are based on scientific principles rather than machine learning training data. The "Sensitivity" section mentions evaluating 9 different strains of Strep A to determine minimum detectable levels, which could be considered part of the R&D/optimization phase, but not a formal "training set" in the AI sense.

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

   • As no formal training set is identified in the document (in the context of machine learning), the establishment of ground truth for a training set is not applicable. The development of the device's capabilities would have relied on laboratory testing against known concentrations of Strep A antigens and strains.

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The ACON® One Step Multi-Drug Multi-Line Screen Test Card and Test Device are rapid chromatographic immunoassays for the qualitative and simultaneous detection of two to six drugs in a variety of combinations in human urine. The designated cut-off concentrations for these drugs are as follows: Amphetamine at 1,000 ng/ml, Cocaine at 300 ng/ml, Methamphetamine at 1,000 ng/ml, Opiates at 2,000 ng/ml, Marijuana at 50 ng/ml and Phencyclidine at 25 ng/ml. They are intended for healthcare professionals including professionals at the point of care sites.

The ACON One Step Multi-Drug Multi-Line Screen Test Card and Test Device are competitive binding, lateral flow immunochromatographic assays for the qualitative and simultaneous detection of Amphetamine, Cocaine, Methamphetamine, Opiates, Marijuana, and Phencyclidine in urine samples. The test is based on the principle of antigen-antibody immunochemistry. It utilizes mouse monoclonal antibodies to selectively detect elevated levels of Amphetamine, Methamphetamine, Cocaine, Opiates, THC and PCP in urine at the cut-off concentrations of 1,000 ng/ml (AMP), 1,000 ng/ml (mAMP), 300 ng/mL (COC), 2,000 ng/ml (OPI), 50 ng/ml (THC) and 25 ng/ml (PCP). These tests can be performed without the use of an instrument.

A positive urine specimen will not generate a colored-line for the specific drug tested in the designated test region. A negative urine specimen or a urine specimen containing of Amphetamine, Cocaine, Methamphetamine, Opiates, Marijuana, and Phencyclidine at the concentrations below the designated cut-off levels will generate a colored-line in the designated test region for the drug. To serve as a procedural control, a colored-line will always appear at the control region, indicating that proper volume of specimen has been added and membrane wicking has occurred.

Here's an analysis of the acceptance criteria and study details for the ACON One Step Multi-Drug Multi-Line Screen Test Card and Test Device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the ACON One Step Multi-Drug Multi-Line Screen Test Card and Test Device appear to be based on achieving high agreement rates (positive, negative, and overall) with both previously FDA-cleared single drug tests and Gas Chromatography/Mass Spectrometry (GC/MS) analysis. While specific numeric acceptance thresholds are not explicitly stated as "acceptance criteria," the consistently high percentage agreements demonstrated in the results (mostly 95% and above, often 99%) with narrow confidence intervals imply that such high agreement was the de facto criterion for acceptance.

Device Performance vs. Predicate Device (ACON Single Tests):

Device Performance vs. GC/MS Analysis:

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

• Sample Size: Over 1,000 clinical urine specimens were employed. Approximately 10% of these samples had drug concentrations in the -25% to +25% cut-off range.
• Data Provenance: The data is described as "clinical urine specimens," implying they were collected from real-world patients. The country of origin is not explicitly stated, but the submission is to the FDA (USA), suggesting the data is relevant to US clinical settings, though not necessarily collected in the US. The study is retrospective, as it uses existing clinical specimens to compare the new device against established methods.

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

The document does not explicitly state the number or qualifications of experts used to establish the ground truth.

• For the comparison with predicate devices, the "ground truth" seems to be the result from the previously FDA-cleared ACON single drug tests. These are also immunochromatographic tests.
• For the comparison with GC/MS analysis, the GC/MS result is considered the gold standard "ground truth." GC/MS analysis is a laboratory-based method. The qualifications of the personnel performing or interpreting the GC/MS results are not specified, although it is a recognized analytical standard in toxicology.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1). The comparison is direct: the new device's result is compared to the predicate device's result and to the GC/MS result. Discrepancies are noted in the agreement percentages, but a formal adjudication process for discordant results is not detailed.

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

• No MRMC Study: This is not an AI-assisted diagnostic device. It is a rapid diagnostic test (immunochromatographic assay) designed for qualitative, visual interpretation. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study as typically understood for AI in medical imaging, and the concept of human readers improving with AI assistance, is not applicable here.

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

• Not applicable as this is a physical immunoassay device, not an algorithm. The interpretation of the test result (presence or absence of a colored line) is inherently human-in-the-loop, though it's a straightforward visual inspection, not a complex diagnostic image interpretation task. The "standalone" performance here refers to the device's ability to produce a result that aligns with the ground truth when interpreted as intended. The performance tables do represent the standalone performance of the device when read by a human.

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

Two types of ground truth were used:

1. Predicate Device Results: The results from previously FDA-cleared ACON single drug test strips.
2. GC/MS Analysis (Gas Chromatography/Mass Spectrometry): This is a highly accurate and widely accepted laboratory analytical method for drug detection and quantification in toxicology, considered the "gold standard" for this application.

8. The Sample Size for the Training Set

• The document does not mention a training set. This is because the device is a chemical/immunological assay, not a machine learning or AI algorithm that requires training data. The development of such devices relies on chemical formulation, antibody specificity, and physical design, not data training in the AI sense.

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

• As there is no training set in the context of an AI/ML algorithm, this question is not applicable. The device's design and performance are established through laboratory R&D and then validated using clinical samples against established methods (predicate device and GC/MS) as described above.

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The ACON hCG Urine/Serum One Step Pregnancy Test is a rapid qualitative chromatographic immunoassay for the detection of human chorionic gonadotropin in urine or serum. The ACON hCG Urine/Serum One Step Pregnancy Test is indicated for use as an aid in the early detection of pregnancy.

The ACON hCG Urine/Serum One Step Pregnancy Test is a rapid chromatographic immunoassay (membrane particle assay).

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Urine Test Set:
  • Sample Size: 155 urine specimens.
  • Data Provenance: Not explicitly stated, but it was a "multi-center clinical evaluation," suggesting prospective collection from various clinical sites. No country of origin is mentioned.
• Serum Test Set:
  • Sample Size: 57 serum specimens.
  • Data Provenance: Not explicitly stated, but part of the same "multi-center clinical evaluation," suggesting prospective collection from various clinical sites. No country of origin is mentioned.
• Sensitivity Test Set:
  • Sample Size: 20 clinical samples (from normal, non-pregnant females), spiked with hCG at various concentrations (0, 15, 20, 50, 100 mIU/ml).
  • Data Provenance: Clinical samples from normal, non-pregnant females. The spiking indicates laboratory-controlled conditions.
• Specificity Test Set:
  • Sample Size: Not explicitly stated for each hormone (LH, FSH, TSH) or for interfering substances. The wording "all specimens tested" suggests multiple samples for each.
  • Data Provenance: Specimens with high physiological concentrations of relevant hormones and specimens spiked with potentially interfering substances.

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

Not applicable. This device is an in-vitro diagnostic test for qualitative detection of hCG. The "ground truth" for the accuracy study was established by comparison to another commercially available membrane particle assay, implying the reference device's results were considered the ground truth. For sensitivity, the ground truth was the known concentration of spiked hCG. For specificity, the ground truth was the known presence or absence of specific interfering substances. No human expert interpretation was involved in establishing the ground truth for this type of test.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the ground truth was established either by comparison to a predicate device's results or by known spiked concentrations/substances. There was no human interpretation requiring adjudication.

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 an in-vitro diagnostic device that provides an objective visual result (colored lines); it is not an AI-powered image analysis or diagnostic aid that assists human readers.

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

Yes, the studies described are standalone performance evaluations of the ACON hCG Urine/Serum One Step Pregnancy Test. The device itself performs the detection; there is no human interpretation of an algorithm's output.

7. The Type of Ground Truth Used

• Accuracy: Another "commercially available membrane particle assay" (likely the predicate device or a similar validated test). The results of this comparator assay served as the ground truth.
• Sensitivity: Known, precisely spiked concentrations of hCG in clinical samples.
• Specificity: Known concentrations of other hormones (LH, FSH, TSH) and common interfering substances.

8. The Sample Size for the Training Set

Not applicable. This is a rapid immunoassay test, not a machine learning or AI-based device that requires a "training set." Its principles of operation rely on biochemical reactions, not data-driven model training.

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

Not applicable, as there is no training set for this type of device.

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