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.

Device Description

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.

AI/ML Overview

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

Acceptance Criteria Category	Specific Criteria (if stated or inferred)	Reported Device Performance
Method Comparison Agreement	Accuracy against Predicate Device (Technician read) using Solution Concentrations:- 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

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.
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."
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.
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.
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.
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.
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.
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.

Summary

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Image /page/0/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the most prominent.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 6, 2017

ACON LABORATORIES, INC. QIYI XIE, SR. STAFF CLINICAL/REGULATORY 10125 MESA RIM ROAD SAN DIEGO, CA 92121

Re: K170587

Trade/Device Name: On Call Ketone Reagent Strips for Urinalysis Healthy Me Ketone Reagent Strips for Urinalysis Regulation Number: 21 CFR 862.1435 Regulation Name: Ketones (nonquantitative) test system Regulatory Class: Class I, meets the limitations of exemption per CFR 862.9(c)(9) Product Code: JIN Dated: May 12, 2017 Received: May 15, 2017

Dear Qiyi Xie:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse

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events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and Part 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Kellie B. Kelm -S

for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K170587

Device Name

Healthy MeTM Ketone Reagent Strips for Urinalysis

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Indications for Use

510(k) Number (if known) K170587

Device Name On Call Ketone Reagent Strips for Urinalysis

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤ

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The Assigned 510(k) number is: K170587

Submitter's Identification:

ACON Laboratories, Inc. 10125 Mesa Rim Road San Diego, California 92121

Tel.: 858-875-8011 Fax: 858-875-8099

Date Prepared: May, 12th 2017

Contact Person:

Qiyi Xie MD, MPH Sr. Staff Clinical & Regulatory Affairs

Proprietary Name of the Device:

On Call® Ketone Reagent Strips for Urinalysis Healthy Me™ Ketone Reagent Strips for Urinalysis

Common Name:

Urinalysis Reagent Strips

Regulation Section and Classification:

Regulatory Section: 21 CFR § 862.1435

Class I meets limitations of exemption per 21 CFR 862.9 (c) (9) Classification:

Product Code:

JIN Ketones (urinary, non-quant.) test system

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Panel:

75 Clinical Chemistry

Predicate Device:

Predicate 510(k) number & device name:

K801270 - Bayer Ketostix reagent strips, Urine Dipstick or tablet analysis, non- automated

Device Description:

Intended Use:

1. Intended use:

The On Call® & Healthy Me™ Ketone Reagent Strips for Urinalysis are intended for the qualitative and semi-quantitative detection of Ketoacetic 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® & 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.

2. Special condition for use statement(s):

This submission is for an over-the-counter version of a previously cleared professional device for urine ketones (K061559-ACON Urinalysis Reagent Strips). Lay users can perform the test using the midstream technique or the dip and read technique.

1. Special instrument Requirements: Not Applicable

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Tests Principles:

This test is based on ketones reacting with nitroprusside and acetoacetic acid to produce a color change ranging from light pink for negative results to a darker pink or purple color for positive results. Ketones are normally not present in urine. Detectable ketone levels may occur in urine during physiological stress conditions such as fasting, pregnancy and frequent strenuous exercise. In starvation diets, or in other abnormal carbohydrate metabolism situations, ketones appear in the urine in excessively high concentration before serum ketones are elevated.

Substantial Equivalence:

The On Call® & Healthy Me™Ketone Reagent Strips for Urinalysis are substantially equivalent to the Bayer Ketostix reagent strips.

Characteristic of the On Call® Ketone Reagent Strips for Urinalysis are compared with
the Bayer Ketostix reagent strips in the following table:

Area of Comparison	On Call® & Healthy Me™ Ketone Reagent Strips	Bayer Ketostix reagent strips K801270
Reagent for Ketone(Acetoacetic acid)	Sodium nitroprussideBuffer	Same
Intended Specimen	Urine	Same
Material Provided	Plastic strip affixed with a reagent pad.	Same
KetoneMethodology	Based on ketones reacting with nitroprusside and acetoacetic acid to produce a color change ranging from light pink for negative results to a darker pink or purple color for positive results.	Same
Intended Use	For the qualitative and semi-quantitative detection of ketone in urine.	Same
Intended Usepopulation	For Over the Counter use by lay people	Professionals and for Over the Counter use by lay people
Time Required toRead Strips	15 to 120 seconds	15 seconds
Storage	2 to 30°C (36-86 °F)Do Not Store in refrigerator or freezer. Do Not Store in Direct Sunlight	15 to 30°C (59-86 °F) Do Not Store in refrigerator or freezer. Do Not Store in Direct Sunlight

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Standard/Guidance Document Referenced (if applicable):

CLSI GP16 A3

Performance Characteristics (if/when applicable):

I) Analytical performance: The performance of Ketone reagent strips has been evaluated and present in 510k- K061559-ACON Urinalysis Reagent Strips.
II) Discussion of Clinical Tests Performed:
- i) Method comparison with predicate device:

Approximately over 400 participants volunteered in the study participants were recruited.

Results:

Results of ACON Ketone by Layperson vs Bayer Ketostix by Technician at 3 Sites with the solution concentrations same as color blocks

		Results Bayer Ketostix by Technician at 3 Sites					Total
	Colorblocks	Neg	5	15	40	80	160
Result ofAconKetonestrip bylayperson	Neg	60	0	0	0	0	0	60
	5	0	57	0	0	0	0	57
	15	0	0	55	0	0	0	55
	40	0	0	1	52	0	0	53
	80	0	0	0	0	60	0	60
	160	0	0	0	0	1	61	62
	Total	60	57	56	52	61	61	347
Same blockagreement		60/60	57/57	55/56	52/52	60/61	61/61	99.4%
Agreement within+/- one block		60/60	57/57	56/56	52/52	61/61	61/61	100.0%

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		Result (mg/dL) of Bayer Ketostix by Technician
	Color block	Neg	5mg/dL(+/-)	15mg/dL(+)	40mg/dL(++)	80mg/dL(+++)	160mg/dL(+++)	Total
Results (mg/dL)of ACONKetone ReagentStrip byLayperson	Neg	42	0	0	0	0	0	42
	5 mg/dL(+/-)	0	21	0	0	0	0	21
	15 mg/dL(+)	0	0	6	0	0	0	6
	40 mg/dL(++)	0	0	0	2	0	0	2
	80 mg/dL(+++)	0	0	0	0	0	0	0
	160 mg/dL(++++)	0	0	0	0	0	0	0
	Total	42	21	6	2	0	0	71
Same blockagreement		100%
±1 blockagreement		100%

Participants' Midstream Urine with ACON Ketone Reagent Strips by Layperson vs Urine Collected in Cup with Bayer Ketostix by Technician at 2 sites

III) Clinical Studies:

i) Clinical sensitivity: Not Applicable
ii) Clinical specificity: Not Applicable

IV) Expected values/Reference range:

Normally, no ketones are present in urine. Detectable levels of ketone may occur in urine during physiological stress conditions such as fasting, pregnancy, and frequent strenuous exercise. In starvation diets, or in other abnormal carbohydrate situations, ketones appear in the urine in excessively large amounts before serum ketones are elevated.

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Conclusion:

The Method comparison study with predicate indicates that the intended user (layperson) can follow the product instruction, perform the test and obtained comparable results vs. the predicate device. Layperson also can obtain the comparable results vs the results obtained by technician. 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.

Regulation Number and Section

§ 862.1435 Ketones (nonquantitative) test system.

(a)
Identification. A ketones (nonquantitative) test system is a device intended to identify ketones in urine and other body fluids. Identification of ketones is used in the diagnosis and treatment 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 and patients with diabetes.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.