J&S Medical Associates Sentry dipstick urine controls are intended to be used by laboratory technicians in order to verify the performance of various urine dipsticks as a part of the laboratory's quality control practices.

Device Description

The three Sentry controls are prepared with human and animal proteins and with various chemical additives. These chemicals interact with the dipstick reactant pads to produce specific color changes that mimic actual normal and/or abnormal urine samples.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the J&S Medical Sentry Urine Dipstick Control:

The provided document is a 510(k) Summary for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed de novo clinical trial for efficacy. Therefore, much of the requested information (like specific acceptance criteria for a diagnostic performance metric, MRMC studies, or training set details) is not present. The "study" described is primarily a stability evaluation.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly related to the stability of the controls – that they continue to react "within specifications" and produce "positive" or expected results with dipsticks over time, mimicking actual urine samples. The reported device performance is that it met these stability specifications.

Acceptance Criteria (Implicit)	Reported Device Performance
Maintain performance within specifications for 65 days at 4°C, ambient, 25°C, and 37°C when tested with Quidel and Bayer dipsticks.	All controls performed "within specifications" after 65 days incubation at 37°C.
Maintain hCG positive response for 120 days at 4°C, 25°C, and 37°C when tested with Quidel QuickVue One-Step hCG Combo.	A positive response for hCG was detected after 120 days.
Maintain performance within specifications for 65 days at ambient temperature (open vial) when tested with Quidel and Bayer dipsticks.	Controls reacted "within specifications" at day 65.
Shelf life of two years.	Indicated a shelf life of two years for all three controls based on the 65-day 37°C stability data.
Open vial shelf life of at least two months.	Indicated open vial shelf life of at least two months based on 65-day ambient stability data.

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

Test Set Description: Samples of the three Sentry controls (Level 1, Level 2, and Level 3).
Sample Size for Stability Testing: Not explicitly stated as a number of distinct "samples" or replicates beyond "Samples of the three controls." The focus is on the long-term observation of these control solutions.
Data Provenance: The study was conducted by J&S Medical Associates. The country of origin of the data is not specified but is presumably the USA, where the company is based. The study is prospective in nature, as it involves incubating the controls and testing them at future intervals.

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

This type of information is not applicable to this submission. The "ground truth" for a urine dipstick control is its known chemical composition and intended reactivity profile. The evaluation involves comparing the control's observed reactions to these known profiles, not to an expert's diagnosis. The testing involved visual comparison to color charts and instrument readings, which are objective measurements.

4. Adjudication Method for the Test Set

Not applicable. The "ground truth" (expected results for the controls) is inherent in their formulation. The stability assessment involves direct measurement and comparison to predefined specifications (visual color chart matching or instrument readings), not expert adjudication of subjective findings.

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 device is a quality control material, not an AI-powered diagnostic tool, and therefore, an MRMC study or AI-related effectiveness analysis is entirely outside the scope of this submission. The device is intended to verify the performance of existing urine dipsticks, which include both visual and instrument-read types.

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

Not applicable. As a urine dipstick control, this device is not an algorithm. Its performance is assessed by its chemical reactivity, not by an algorithm's output.

7. The Type of Ground Truth Used

The ground truth used is the known chemical composition and expected reactivity profile of the control solutions. These controls are manufactured to elicit specific reactions on urine dipsticks. Their performance is verified by ensuring they consistently produce these expected results over time under various conditions.

8. The Sample Size for the Training Set

Not applicable. This device is a chemical control, not a machine learning algorithm, and thus does not have a "training set" in the computational sense. The "training" in manufacturing would relate to process control and formulation development, not data-driven model training.

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

Not applicable. See point 8.

Summary

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JUL 2 5 2002

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 :	K022085
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	Submitter Information
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Submitter's Name:	J&S Medical Associates
Address:	35 Tripp Street, Bldg.1Framingham, MA 01702
Contact Person:	Dr. Paul MacDonnell
Phone:	1-800-229-6000 ext. 157
Fax:	(508) 370-4554
Establishment Registration Number:	1218982

Date Prepared: 06/24/2002

2) Identification of Device

Device Name:	Urine Dipstick Control
Proprietary/ Trade Name:	J&S Medical Sentry Urine Dipstick Control
Common Name:	Urinalysis Controls
Classification Name:	Urinalysis Controls (Assayed and Unassayed)
Device Classification:	1
Regulation Number:	21 CFR 862.1660
Panel:	Clinical Chemistry
Product Code:	JJW

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Identification of the Predicate Device:

Predicate Device Name: The Dropper urine dipstick control Quantimetrix Corporation Manufacturer: 510(k) #: Unknown

4.0 Description of the Device
The three Sentry controls are prepared with human and animal proteins and with various chemical additives. These chemicals interact with the dipstick reactant pads to produce specific color changes that mimic actual normal and/or abnormal urine samples.
4.1 Sentry Level 1 Control is designed to test positive for leukocytes, nitrite. urobilinogen, protein, blood, ketone, bilirubin, and glucose with dipsticks. In addition, this control will have a pH of about 7 with an elevated specific gravity and will test positive for hCG.
4.2 Sentry Level 2 Control is designed to test positive for ascorbic acid, have a pH of about 5, and a moderately elevated specific gravity.
4.3 Sentry Level 3 Control is designed to have a pH of about 7 with a low specific gravity.
5.0 Intended Use

The controls are intended to be used by laboratory technicians in order to verify the performance of urine dipsticks made by various companies.

6.0 Substantial Equivalence
- 6.1 The Sentry Urine Dipstick Controls (Levels 1, 2, and 3) and the Quantimetrix Controls (Level 1 and 2) are supplied as liquids and do not require further treatment before use.
- 6.2 The Sentry and Quantimetrix controls are used to verify the performance of various urine dipsticks.
- 6.3 The Sentry and the Quantimetrix Controls will have value assignments to account for variations in manufacturers' dipstick formulations.

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7.0 Assignment of Expiration date

Samples of the three controls were incubated at 4º C, ambient (for open 7.1 vial room temperature stability), 25° C, and 37° C for 65 days.
The stability of the three controls were assessed as follows: 7.2
- Solutions were tested at frequent intervals using Quidel dipsticks. 7.2.1 The results were recorded visually by comparing reactant pad color intensity to the color chart supplied by Quidel; the results also were measured with the Behring Rapimat II instrument. After 65 days incubation of the controls at 37°, all of the controls performed within specifications, indicating a shelf life of two years for the three controls (Table I).
- 7.2.2 The stability of the controls also was assessed by testing with Baver dipsticks visually and with the Bayer Clinitek 100 instrument. The stability data with the Bayer strips are similar to that with the Quidel strips indicating an expiration date of two vears for the three controls (Table II).
- The stability of hCG in Sentry Level 1 was assessed by testing the 7.2.3 solution at periodic intervals up to 120 at days 4°. 25°, and 37° C. When tested with Quidel QuickVue One-Step hCG Combo lateral flow device a positive response was detected after 120 days. An expiration date of two years can be assigned (Table III).
8.0 Open vial stability of Sentry Controls 1, 2, and 3

Samples of the Sentry Urine Dipstick Control Levels 1, 2, and 3 were stored at ambient temperature (19° C to 22° C). Quidel dipsticks and Bayer dipsticks were used to test the controls at periodic intervals for 65 days. At day 65, the controls reacted within specifications, indicating open vial shelf life of at least two months for the three controls (Tables IV, V)

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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services (USA). The seal features the department's name in a circular arrangement around a stylized caduceus symbol. The caduceus is depicted with three intertwined strands, representing health, services, and human aspects.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 2 5 2002

Ms. Joslyn S. Murphy Ouality Assurance Manager J&S Medical Associates 35 Tripp Street, Bldg. 1 Framingham. MA 01702

Re: K022085

Trade/Device Name: Sentry urine dipstick control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJW Dated: June 24, 2002 Received: June 27, 2002

Dear Ms. Murphy:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and ' additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or. (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

510(K) Number (if known):

Device Name: Sentry urine dipstick control

Indications for Use:

Lein Cooper
(Division Sign-Off)

Division of Clinical Laboratory Devices Kho 510(k) Number_

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Description Use X

(Per 21 CFR 801.109)

Over-The-Counter Use

Regulation Number and Section

§ 862.1660 Quality control material (assayed and unassayed).

(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.