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The Healthy Me™ Ketone Reagent Strips for Urinalysis are intended for the qualitative and semi-quantitative detection of Ketone (Acetoacetic acid) in urine. The identification of ketones is used in the diagnosis of acidosis (a condition characterized by abnormally high acidity of body fluids) or ketosis (a condition characterized by increased production of ketone bodies such as acetone) and for monitoring patients on ketogenic diets.

The Healthy Me™ Ketone Reagent strips are intended for Over the Counter use by lay people with Diabetes and/or people on low carb diets at home to check for the ketones in urine. This product is not intended for the management of diabetes.

The On Call Ketone Reagent Strips for Urinalysis are intended for the qualitative and semi-quantitative detection of Ketone (Acetoacetic acid) in urine. The identification of ketones is used in the diagnosis of acidosis (a condition characterized by abnormally high acidity of body fluids) or ketosis (a condition characterized by increased production of ketone bodies such as acetone) and for monitoring patients on ketogenic diets.

The On Call Ketone Reagent strips are intended for Over the Counter use by lay people with Diabetes and/or people on low carb diets at home to check for the ketones in urine. This product is not intended for the management of diabetes.

On Call® & Healthy Me" Ketone Reagent Strips for Urinalysis consists of a Plastic Strip to which a regent pad is affixed. The reagent pad reacts with the urine and provides a visible color reaction. On Call® & Healthy Me™ Ketone Reagent Strips for Urinalysis are packaged along with a drying agent in a Canister bottle. Each strip is stable and ready to use upon removal from the Canister. The entire reagent strip is disposable. Results are obtained by direct comparison to the test strip with a color blocks printed on the bottle label. Accurate timing is essential to provide optimal results. No calculations or laboratory instruments are needed.

Here's an analysis of the provided text regarding the acceptance criteria and study for the On Call/Healthy Me Ketone Reagent Strips for Urinalysis:

Introduction to the Device
The device, On Call® & Healthy Me™ Ketone Reagent Strips for Urinalysis, is intended for the qualitative and semi-quantitative detection of acetoacetic acid (ketones) in urine. It's designed for over-the-counter use by laypersons, including those with diabetes or on low-carb diets, to monitor for ketones at home. The test is based on a color change reaction with nitroprusside and acetoacetic acid, ranging from light pink (negative) to darker pink/purple (positive).

Acceptance Criteria and Device Performance

• Same block agreement: High agreement across all color blocks.
• Agreement within +/- one block: Very high agreement across all color blocks. | 1. Results of ACON Ketone by Layperson vs Bayer Ketostix by Technician at 3 Sites with solution concentrations matching color blocks:
• Same block agreement: 99.4% (ranging from 55/56 for 15 mg/dL to 60/60 for Neg, 5mg/dL, 40mg/dL, and 61/61 for 160mg/dL, and 60/61 for 80mg/dL).
• Agreement within +/- one block: 100.0%. |
  | User Performance Agreement | Accuracy against Predicate Device (Technician read) using Participant Midstream Urine:
• Same block agreement: High agreement across all color blocks where predicate showed results.
• Agreement within +/- one block: Very high agreement across all color blocks where predicate showed results. | 2. Participants' Midstream Urine with ACON Ketone Reagent Strips by Layperson vs Urine Collected in Cup with Bayer Ketostix by Technician at 2 sites:
• Same block agreement: 100% for observable results where data is provided (Neg, 5 mg/dL, 15 mg/dL, 40 mg/dL). Note: No results reported for 80 mg/dL or 160 mg/dL when read by layperson with ACON, while technician with Bayer showed 0 for these too. This suggests either these levels were not present in midstream urine or were not detected by either device/method. |
  | Substantial Equivalence | Demonstrate substantial equivalence to the predicate device (Bayer Ketostix reagent strips K801270) in terms of intended use, principle, reagents, specimen, methodology, and performance. | The conclusion explicitly states: "The above mentioned results demonstrate that the On Call and Healthy Me Ketone reagent strips for urinalysis are substantially equivalent to legally marketed predicate device currently sold on the U.S. market." |
  | Analytical Performance | Reference to prior 510(k) (K061559) for ACON Urinalysis Reagent Strips. | "The performance of Ketone reagent strips has been evaluated and present in 510k- K061559-ACON Urinalysis Reagent Strips." (The specific acceptance criteria from K061559 are not detailed here, but the statement implies they were met). |
  | Clinical Sensitivity/Specificity | Not applicable; assumed to be covered by the method comparison and substantial equivalence to a predicate for which these were established. | Not Applicable. |

Study Details

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

   • Study 1 (Solutions): 347 samples. These were solution concentrations designed to match the color blocks. The provenance is not explicitly stated beyond being conducted at "3 Sites." It's likely a controlled laboratory study rather than patient samples.
   • Study 2 (Midstream Urine): 71 samples. These were "Participants' Midstream Urine." The provenance is not explicitly stated beyond being conducted at "2 sites." It's likely prospective collection for the purpose of the study.

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

   • Ground truth was established by a "Technician" reading the predicate device (Bayer Ketostix).
   • The number of technicians is not specified.
   • Their qualifications are not specified (e.g., years of experience, specific certifications), other than being identified as "Technician."

3. Adjudication method for the test set:

   • The document implies that the technician's reading of the predicate device was taken as the reference standard (ground truth). There is no mention of a
     multi-reader adjudication method (e.g., 2+1, 3+1) for establishing this ground truth.

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:

   • This was not an MRMC study comparing human readers with and without AI assistance. This study compared a layperson reading the investigational device against a technician reading a predicate device.
   • Therefore, no effect size related to AI assistance for human readers is applicable or provided.

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

   • No, this device is a manual reagent strip read by a human (layperson). It does not involve an algorithm or AI.

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

   • The ground truth was established by a "Technician" reading the predicate device (Bayer Ketostix) and comparing the color change to the color blocks. This is a form of reference standard comparison to a legally marketed predicate device, where the predicate read by a trained professional serves as the benchmark. For the first study, it was confirmed against known solution concentrations.

7. The sample size for the training set:

   • The document does not explicitly state a separate "training set" for the current device. The performance evaluation presented is for the validation/test set. It mentions that "The performance of Ketone reagent strips has been evaluated and present in 510k- K061559-ACON Urinalysis Reagent Strips," implying a prior validation for a professional version of the device, which would have had its own training/test data.

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

   • Since a training set for this specific submission is not specified, how its ground truth was established is not detailed in this document. For the predicate device (Bayer Ketostix) and the previously cleared professional device (K061559), the ground truth would have likely been established through reference laboratory methods (e.g., spectrophotometry, enzymatic assays) for quantitative ketone levels, which are then correlated with the semi-quantitative color scale.

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