(76 days)
None
No
The device description and performance studies focus on chemical and physical properties of urine controls, with no mention of AI or ML for analysis or interpretation.
No.
The device is described as an "assayed urine control" intended to validate the precision of urinalysis readings, not to treat a medical condition.
No
This device is a urine control intended to validate the precision of other urinalysis instruments and visual readings, not to diagnose a condition itself.
No
The device description clearly indicates the device is a physical product (liquid and dry strips) used as controls for urinalysis, not a software application.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "It is intended for professional in vitro diagnostic use only."
- Function: The device is a control used to validate the precision of urinalysis tests, which are performed in vitro (outside the body) on a biological sample (urine).
- Purpose: Its purpose is to ensure the consistent performance of other IVD devices (Mission Urinalysis Reagent Strips and Mission Urine Analyzers).
The description clearly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
JJW
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional in vitro diagnostic use only.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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)
1
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:
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
2
Intended Use:
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.
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 |
| Storage | ||
| Temperature | 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°C | |
| 30 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), Specific | ||
| Gravity, Blood, pH, Protein, | ||
| Urobilinogen, Nitrite, | ||
| Leukocytes and Ascorbic Acid | Glucose, Bilirubin, Ketone | |
| (Acetoacetic acid), Specific | ||
| Gravity, Blood, pH, Protein, | ||
| Urobilinogen, Nitrite, Leukocytes | ||
| and Ascorbic Acid |
3
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 Urine
Control | Bio-Rad Laboratories
Liquicheck Urinalysis Control |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | For use as an assayed quality
control urine to monitor the
precision of urinalysis test
procedures for the analytes listed
in 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°C
30 days at 15-30°C | 30 months at 2-8°C
30 days at room temperature
(18-25°C) |
| Shelf Life | 24 months at 2-8°C | 30 months at 2-8°C |
| Packaging
Configuration | Dropper, diptube | Dropper |
| Analytes | Glucose, Bilirubin, Ketone
(Acetoacetic acid), Specific
Gravity, Blood, pH, Protein,
Urobilinogen, Nitrite,
Leukocytes and Ascorbic Acid | Glucose, Bilirubin, Ketone
(Acetoacetic acid), Specific
Gravity, Blood, pH, Protein,
Urobilinogen, Nitrite, Leukocytes,
Creatinine, Microalbumin,
Microscopics (RBC, WBC,
Crystals), Osmolality, Pregnancy
(hCG), Protein-to-Creatinine Ratio |
4
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 Diagnostics
Chek-Stix Positive and Negative
Controls Strips for Urine
Chemistry |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | For use as an assayed quality
control urine to monitor the
precision of urinalysis test
procedures for the analytes listed
in the package insert | Same |
| Form | Dry strip | Same |
| Levels | 2 | Same |
| Maximum Tests per
unit | 12 | Same |
| Incubation Time | 30 minutes | Same |
| Analytes | Glucose, Bilirubin, Ketone
(Acetoacetic acid), Specific
Gravity, 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 after
Reconstitution | 8 hours for all parameters | 8 hours for all parameters except 3
hours 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.
5
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.
6
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:
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.
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
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