The Mission Liquid Urine Control, Mission Liquid Diptube Urine Control and Mission Dry Strip Urine Control are assayed urine controls intended for use in validating the precision of visual and analyzer reading of urinalysis for one or more of the following analytes: Ascorbic acid, Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocytes. It is intended for professional in vitro diagnostic use only.

Device Description

The Mission Liquid Urine Control and Mission Liquid Diptube Urine Control are prepared from simulated human urine with purified chemicals, constituents of animal origin, preservatives and stabilizers. The controls are available in two levels, ready to use liquid format packaged in dropper bottles under the brand name Mission Liquid Urine Control and in diptube containers under the brand name Mission Liquid Diptube Urine Control. The results of the Mission Liquid Urine Control and Mission Liquid Diptube Urine Control are compared to the lot-specific expected values listed in the package insert to ensure the consistent performance of Mission Urinalysis Reagent Strips and Mission Urine Analyzers.

The Mission Dry Strip Urine Control are firm plastic strips onto which reagent areas are affixed. The negative level strips have five reagent areas containing one or more synthetic ingredients. When placed in a measured quantity of distilled or deionized water, the ingredients dissolve out of the reagent areas to produce a Level 1 Control Solution. The Level 2 strips have six reagent areas affixed. The ingredients on the positive level strips dissolve out to produce a Level 2 Control Solution. The results of the Mission Dry Strip Urine Control are compared to the lot-specific expected values listed in the package insert to ensure the consistent performance of Mission Urinalysis Reagent Strips and Mission Urine Analyzers

AI/ML Overview

The provided 510(k) summary (K103387) describes the "Mission Liquid Urine Control, Mission Liquid Diptube Urine Control, and Mission Dry Strip Urine Control" devices. However, it does not explicitly state specific, quantifiable acceptance criteria or provide a detailed study that proves the device meets such criteria.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices. The "Discussion of Non-Clinical Tests Performed" section broadly lists types of evaluations conducted (matrix effects, control value assignment, temperature flexibility, humidity effect, lighting effect, number of dip times, incubation time, and shelf life and stability), but it does not present the results of these tests in a way that allows for the extraction of acceptance criteria or performance metrics directly from this document.

The "Conclusion" states: "The laboratory testing demonstrates that the Mission Liquid Urine Control, Mission Liquid Diptube Urine Control and Mission Dry Strip Urine Control are safe, accurate and easy-to-use. It also demonstrates that the Mission Liquid Urine Control, Mission Liquid Diptube Urine Control and Mission Dry Strip Urine Control are substantially equivalent to the Bio-Rad Laboratories Liquicheck Urinalysis Control and Siemens Healthcare Diagnostics Inc. Chek-Stix Positive and Negative Control Strips for Urine Chemistry, currently sold on the U.S. market."

Based on the provided text, the specific information requested cannot be fully extracted in the format desired for acceptance criteria and a performance study. Here's a breakdown of what can be inferred or directly stated from the document, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Cannot be fully provided as specific, quantifiable acceptance criteria and performance data are not detailed in the provided 510(k) summary. The document focuses on demonstrating substantial equivalence through a comparison of technological characteristics and general statements about testing.

Acceptance Criteria (Inferred from Predicate Equivalence)	Reported Device Performance (Inferred from "Substantial Equivalence")
Intended Use: For use as an assayed quality control urine to monitor the precision of urinalysis test procedures for listed analytes.	Met, as the intended use is "Same" as predicate devices.
Form: Liquid (for Liquid/Diptube), Dry strip (for Dry Strip).	Met, as the form is "Same" as predicate devices.
Levels: 2	Met, as the number of levels is "Same" as predicate devices.
Storage Temperature: 2-8°C (Liquid/Diptube), 2-30°C (Dry Strip).	Met, though with slight differences in range for Dry Strip compared to predicate (2-30°C vs. 15-30°C), considered substantially equivalent.
Shelf Life: 24 months (Liquid/Diptube & Dry Strip).	Met, though with slight differences compared to predicates (24 months vs. 30 months for Liquid, 24 months vs. 18 months for Dry Strip), considered substantially equivalent.
Open Stability: Varies by device type and temperature.	Met, though with differences in duration and temperature compared to predicates, considered substantially equivalent.
Analytes Covered: Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, Leukocytes, Ascorbic Acid.	Met, as listed analytes are "Same" as predicate for Dry Strip, and largely similar for Liquid (predicate has more).
Maximum Tests per Unit: 20 (diptube), 12 (dry strip).	Met, as listed. For Dry Strip, "Same" as predicate.
Preservatives: 0.02% Proclin	Met, as listed.
Temperature Flexibility: Demonstrated through testing.	Not specified quantitatively.
Humidity Effect: Demonstrated through testing.	Not specified quantitatively.
Lighting Effect: Demonstrated through testing.	Not specified quantitatively.
Number of Dip Times (diptube and dry strip only): Demonstrated through testing.	Not specified quantitatively.
Incubation Time (dry strip only): Demonstrated through testing (30 minutes).	Met, as listed. "Same" as predicate.
Shelf Life and Stability: Demonstrated through testing.	Not specified quantitatively beyond stated shelf life values.
Matrix Effects: Demonstrated through testing.	Not specified quantitatively.
Control Value Assignment: Demonstrated through testing.	Not specified quantitatively.

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

Sample Size: Not specified in the provided document. The text only refers to "Laboratory Testing" and "studies" without detailing the number of units or measurements included in these evaluations.
Data Provenance: Not specified. The document does not mention the country of origin of the data or whether the studies were retrospective or prospective.

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

Not applicable based on the provided document. The device is a quality control material intended for validating the precision of urinalysis instruments and visual reading. The "ground truth" for such controls typically involves precisely manufactured solutions with known concentrations of analytes, not expert interpretation of results. The document states "control value assignment" was evaluated through laboratory testing, implying these values are determined analytically rather than by expert consensus.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the "ground truth" for this type of device is likely based on precise chemical formulation and analytical validation, not expert adjudication of subjective assessments.

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 for urinalysis, not an AI-powered diagnostic tool. No MRMC study or AI assistance is mentioned or relevant to this device type.

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

Not applicable. This device is a quality control material, not an algorithm, and does not involve AI or human-in-the-loop performance in the context of its function.

7. The Type of Ground Truth Used

The ground truth for this type of device (urinalysis control) would be based on known, precisely manufactured concentrations of analytes within the control solutions. The document mentions "control value assignment" was evaluated, which supports this. It is a "manufacturer-assigned value" (also often referred to as an "assayed control").

8. The Sample Size for the Training Set

Not applicable. This device is a quality control material, not an AI model or algorithm that requires a "training set."

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

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

Summary

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FEB - 2 2011

ട. 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 K103387

Submitter's Identification:

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

Tel.: 858-875-8019 Fax: 858-875-8099

Date Prepared: November 2010

Contact Person:

Richard Lenart Regulatory Affairs Manager

Proprietary Name of the Devices:

Mission® Liquid Urine Control, Mission® Liquid Diptube Urine Control, Mission® Dry Strip Urine Control

Common Name:

Urinalysis Controls

Regulation Section and Classification:

Quality control material (assayed and unassayed) 21 CFR § 862.1660

Class I (general controls)

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Product Code:

JJW Urinalysis controls (assayed and unassayed)

Medical Specialty:

Clinical Chemistry

Predicate Device:

Bio-Rad Liquicheck™ Urinalysis Control Bio-Rad Laboratories, Hercules, CA 94547 USA 510(k) Number: K070848

Chek-Stix® Positive and Negative Control Strips for Urine Chemistry Siemens Healthcare Diagnostics Inc., Tarrytown NY 10591 USA 510(k) Number: K931467 (Original submitter: Heraeus Kulzer Inc.)

Description:

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Intended Use:

Technological Characteristics:

Feature	Specifications
	Mission Liquid Urine Control;Mission Liquid Diptube Urine Control	Mission Dry Strip Urine Control
Format	Liquid, ready to use	Dry, reconstituted with DI water
Levels	2	2
StorageTemperature	35-46°F (2-8°C)	35-86°F (2-30°C)
Shelf Life	24 months 2-8°C	24 months at 2-30°C
Open Stability	24 months at 2-8°C30 days at 15-30°C	3 months at 2-30°C;8 hours after reconstituted
Maximum No.Tests per Unit	20 tests (diptube only)	12 tests per reconstituted control
Preservatives	0.02% Proclin	0.02% Proclin
Analytes	Glucose, Bilirubin, Ketone(Acetoacetic acid), SpecificGravity, Blood, pH, Protein,Urobilinogen, Nitrite,Leukocytes and Ascorbic Acid	Glucose, Bilirubin, Ketone(Acetoacetic acid), SpecificGravity, Blood, pH, Protein,Urobilinogen, Nitrite, Leukocytesand Ascorbic Acid

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Comparison to Predicate Devices:

The Mission Liquid Urine Control and Mission Liquid Diptube Urine Control are substantially equivalent to the Bio-Rad Laboratories Liquicheck Urinalysis Control.

Feature	Mission Liquid Urine Control;Mission Liquid Diptube UrineControl	Bio-Rad LaboratoriesLiquicheck Urinalysis Control
Similarities
Intended Use	For use as an assayed qualitycontrol urine to monitor theprecision of urinalysis testprocedures for the analytes listedin the package insert	Same
Form	Liquid	Same
Levels	2	Same
Storage Temperature	2-8°C	Same
Differences
Matrix	Liquid matrix solution	Human urine
Open Vial	24 months at 2-8°C30 days at 15-30°C	30 months at 2-8°C30 days at room temperature(18-25°C)
Shelf Life	24 months at 2-8°C	30 months at 2-8°C
PackagingConfiguration	Dropper, diptube	Dropper
Analytes	Glucose, Bilirubin, Ketone(Acetoacetic acid), SpecificGravity, Blood, pH, Protein,Urobilinogen, Nitrite,Leukocytes and Ascorbic Acid	Glucose, Bilirubin, Ketone(Acetoacetic acid), SpecificGravity, Blood, pH, Protein,Urobilinogen, Nitrite, Leukocytes,Creatinine, Microalbumin,Microscopics (RBC, WBC,Crystals), Osmolality, Pregnancy(hCG), Protein-to-Creatinine Ratio

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The Mission Dry Strip Urine Control is substantially equivalent to the Siemens Healthcare Diagnostics Inc. Chek-Stix Positive and Negative Control Strips for Urine Chemistry.

Feature	Mission Dry Strip Urine Control	Siemens Healthcare DiagnosticsChek-Stix Positive and NegativeControls Strips for UrineChemistry
Similarities
Intended Use	For use as an assayed qualitycontrol urine to monitor theprecision of urinalysis testprocedures for the analytes listedin the package insert	Same
Form	Dry strip	Same
Levels	2	Same
Maximum Tests perunit	12	Same
Incubation Time	30 minutes	Same
Analytes	Glucose, Bilirubin, Ketone(Acetoacetic acid), SpecificGravity, Blood, pH, Protein,Urobilinogen, Nitrite,Leukocytes and Ascorbic Acid	Same
Differences
Storage Temperature	2-30°C	15-30°C
Open Vial	3 months at 35-86°F (2-30°C)	18 months at 15-30 °C
Shelf Life	24 months at 2-30°C	18 months at 15-30 °C
Stability afterReconstitution	8 hours for all parameters	8 hours for all parameters except 3hours for bilirubin

Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

Guidance document included the FDA "Guidance for Industry and FDA Staff Assayed and Unassayed Quality Control Material, Issued on June 7, 2007"

Laboratory Testing:

The performance characteristics of the Mission Liquid Urine Control, Mission Liquid Diptube Urine Control and Mission Dry Strip Urine Control were evaluated by the following studies: matrix effects, control value assignment, temperature flexibility, humidity effect, lighting effect, number of dip times (diptube and dry strip only), incubation time (dry strip only), and shelf life and stability.

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Discussion of Clinical Tests Performed:

Not Applicable.

Conclusion:

The laboratory testing demonstrates that the Mission Liquid Urine Control, Mission Liquid Diptube Urine Control and Mission Dry Strip Urine Control are safe, accurate and easy-to-use. It also demonstrates that the Mission Liquid Urine Control, Mission Liquid Diptube Urine Control and Mission Dry Strip Urine Control are substantially equivalent to the Bio-Rad Laboratories Liquicheck Urinalysis Control and Siemens Healthcare Diagnostics Inc. Chek-Stix Positive and Negative Control Strips for Urine Chemistry, currently sold on the U.S. market.

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Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

ACON Laboratories, Inc. c/o Richard Lenart Regulatory Affairs Manager 10125 Mesa Rim Road San Diego, CA 92121 USA

FEB 0 2 2011

Re: K103387

Trade Name: Mission Liquid Urine Control. Mission Liquid Diptube Urine Control, Mission Dry Strip Urine Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (Assayed and Unassayed) Regulatory Class: Class I, Reserved Product Codes: JJW Dated: January 13, 2011 Received: January 18, 2011

Dear Mr. Lenart:

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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

and the comments of the comments of the comments of

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Page 2 -

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

CJC.

Courtney Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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4. INDICATIONS FOR USE STATEMENT

K103387 510(k) Number (if known):

Mission® Liquid Urine Control Device Name: Mission® Liquid Diptube Urine Control Mission® Dry Strip Urine Control

Indications for Use:

Over-The-Counter Use Prescription Use X ============================================================================================================================================================================ AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Signature

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

. .

510(k) K103387

Page 1 of 1

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.