(128 days)
K061559-ACON Urinalysis Reagent Strips
No
The device description explicitly states that results are obtained by direct comparison to color blocks and that no calculations or laboratory instruments are needed. There is no mention of any computational analysis or learning algorithms.
No.
This device is an in-vitro diagnostic device used for the qualitative and semi-quantitative detection of ketones in urine. It is not used for treating or providing therapy.
Yes
The stated "Intended Use / Indications for Use" directly mentions that "The identification of ketones is used in the diagnosis of acidosis... or ketosis".
No
The device description explicitly states it consists of a "Plastic Strip to which a regent pad is affixed" and is a "disposable" physical strip that reacts with urine. This indicates a hardware component, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the device is for the "qualitative and semi-quantitative detection of Ketone (Acetoacetic acid) in urine." This is a test performed on a biological sample (urine) outside of the body to provide information about a person's health status.
- Purpose: The identification of ketones is used in the "diagnosis of acidosis or ketosis" and for "monitoring patients on ketogenic diets." These are diagnostic and monitoring purposes related to health conditions.
- Device Description: The device is a "reagent strip" that "reacts with the urine and provides a visible color reaction." This describes a test that analyzes a biological sample using chemical reagents.
These characteristics align directly with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
The Healthy MeTM 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 MeTM 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.
Product codes (comma separated list FDA assigned to the subject device)
JIN
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Urine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over the Counter use by lay people with Diabetes and/or people on low carb diets at home
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Method comparison study:
Approximately over 400 participants volunteered in the study.
Study 1: Results of ACON Ketone by Layperson vs Bayer Ketostix by Technician at 3 Sites with the solution concentrations same as color blocks.
- Same block agreement: 99.4%
- Agreement within +/- one block: 100.0%
Study 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%
- +/-1 block agreement: 100%
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Same block agreement, Agreement within +/- one block.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K801270 - Bayer Ketostix reagent strips, Urine Dipstick or tablet analysis, non- automated
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K061559-ACON Urinalysis Reagent Strips
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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
1
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)
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.
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)
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.
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.
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."
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:
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.
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.
-
- 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 nitroprusside | |
| Buffer | Same | |
| Intended Specimen | Urine | Same |
| Material Provided | Plastic strip affixed with a reagent pad. | Same |
| Ketone | ||
| Methodology | 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 Use | ||
| population | For Over the Counter use by lay people | Professionals and for Over the Counter use by lay people |
| Time Required to | ||
| Read 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 | |||||||
|---|---|---|---|---|---|---|---|---|
| Color | ||||||||
| blocks | Neg | 5 | 15 | 40 | 80 | 160 | ||
| Result of | ||||||||
| Acon | ||||||||
| Ketone | ||||||||
| strip by | ||||||||
| layperson | 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 block | ||||||||
| agreement | 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 | 5 | ||||||
| mg/dL | ||||||||
| (+/-) | 15 | |||||||
| mg/dL | ||||||||
| (+) | 40 | |||||||
| mg/dL | ||||||||
| (++) | 80 | |||||||
| mg/dL | ||||||||
| (+++) | 160 | |||||||
| mg/dL | ||||||||
| (+++) | Total | |||||||
| Results (mg/dL) | ||||||||
| of ACON | ||||||||
| Ketone Reagent | ||||||||
| Strip by | ||||||||
| Layperson | 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 block | ||||||||
| agreement | 100% | |||||||
| ±1 block | ||||||||
| agreement | 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.