(30 days)
Not Found
No
The document describes a urine control product used for calibrating and evaluating the performance of automated and manual urine analyzers. There is no mention of AI or ML being used within the control product itself or in the analysis of the control results. The performance studies focus on precision and stability, not on algorithmic performance metrics typically associated with AI/ML.
No.
This device is an in-vitro diagnostic control used for evaluating the accuracy and precision of automated procedures that measure urinary sediment and chemistry parameters. It is intended for laboratory use to quality control other devices, not for direct therapeutic intervention on a patient.
No
The device is described as an "assayed chemistry and cellular urine control for evaluating the accuracy and precision of automated procedures." It is an in-vitro diagnostic control product, used to verify the performance of other diagnostic instruments, rather than diagnosing a condition itself.
No
The device description clearly states it is an "in-vitro diasis control" containing physical components like "stabilized mammalian red blood cells and white blood cells, stabilized bacteria, and simulative medium," packaged in a bottle. This indicates a physical, reagent-based device, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is a "control for evaluating the accuracy and precision of automated procedures that measure urinary sediment and chemistry parameters". This indicates it is used in vitro (outside the body) to assess the performance of other diagnostic devices.
- Device Description: The device description states "UA-Cellular® Complete is a three-level, in-vitro diasis control". While "diasis" appears to be a typo and likely intended to be "diagnostic", the phrase "in-vitro control" clearly identifies it as an IVD.
- Function: The device contains stabilized biological components and chemicals designed to mimic urine samples with known values for various parameters. This is the core function of an IVD control – to provide a known standard for testing diagnostic instruments and methods.
- Performance Studies: The document details various performance studies (precision, stability) conducted to demonstrate the device's suitability for its intended use in a laboratory setting. These types of studies are standard for IVD devices.
Therefore, based on the provided information, UA-Cellular® Complete is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
UA-Cellular® Complete is an assayed chemistry and cellular urine control for evaluating the accuracy and precision of automated procedures that measure urinary sediment and chemistry parameters on the following instruments and testing methods: Sysmex® UF-1000i™ Automated Urine Particle Analyzer: Siemens® Clinitek Atlas Automated Urine Chemistry Analyzer utilizing the Clinitek Atlas 10 Reagent Pak; the Arkray AUTION HYBRID™ AU-4050 fullyautomated integrated urine analyzer: utilizing the Aution sticks 10EA Reagent strips: Siemens Clinitek Status® line of automated chemistry strip reader analyzers; Manual Reading of Urine Refractive Index; Manual Reading of the Siemens Multistix® 10SG Reagent Strips, and the Siemens Clinitest® hCG Pregnancy test.
The list of assayed parameters includes:
Sysmex® UF-1000i™: RBC(/uL), WBC(/uL), Epithelial (/uL), Cast (/uL), Bacteria (/uL), Crystals
Arkray AU-4050: RBC(/uL), WBC(/uL), Epithelial (/uL), Cast (/uL), Bacteria (/uL), Crystals
Arkray AU-4050 with Aution sticks 10EA Reagent strips : Glucose (mg/dL), Bilirubin (As Measured), Ketones (mg/dL), Specific Gravity (As Measured), pH (As Measured), pH (As Measured), Protein (mg/dL), Urobilinogen (EU/dL), Nitrite (As Measured), Leukocytes (As Measured), Color (As Measured), Turbidity (As Measured)
Siemens ® Clinitek Atlas with Atlas 10 Reagent Pak: Glucose (mg/dL), Bilirubin (As Measured), Ketones (mg/dL), Specific Gravity (As Measured), Blood (As Measured), pH (As Measured), Protein (mg/dL), Urobilinogen (EU/dL), Nitrite (As Measured), Leukocytes (As Measured), Color (As Measured), Clarity (As Measured)
Siemens Clinitek Status System line with Multistix 10SG Reagent Strips: Glucose (mg/d); Bilirubin (As Measured), Ketones (mg/dL), Specific Gravity (As Measured), Blood (As Mesured), pH (As Measured), Protein (me/dL), Urobilinogen (EU/dL), Nitrite (As Measured), Leukocytes (As Measured)
Siemens Multistix 10SG Reagent Strips: Glucose (mg/dL), Bilirubin (As Measured), Specific Gravity (As Measured), Blood (As Measured), pH (As Measured), Protein (mg/dL), Urobilinogen (EU/dL), Nitrite (As Measured), Leukocytes (As measured)
Siemens Clinitest hCG Pregnancy Test Cassette: Pregnancy hCG (As Measured)
Manual Confirmatory Testing: Refractive Index (nD)
Product codes
JJW
Device Description
UA-Cellular® Complete is a three-level, in-vitro diasis control that contains the following: stabilized mammalian red blood cells and white blood cells, stabilized bacteria, and simulative medium. Analyte levels are adjusted with appropriate chenicals. The product is packaged in a 4 oz. amber plastic bottle with a foil-lined flip-top cap. The product must be stored at 2-10°C.
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
Not Found
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)
-
Multi-Site Precision Study:
- Cellular Instrument Study: Collected for the Arkray AU4050. Study was conducted per EP05-A3 across 3 instruments at three different sites. A single operator was used at each site ran each lot and level of control for 5 days, 2 runs per day, and 3 replicates per run.
- Chemistry Instrument Study: Conducted utilizing Siemens CLINITEK Atlas, Siemens Status System Line, Arkray AUTION HYBRID AU-4050, Manual Reading of Siemens Multistix 10SG Reagent Strips, Manual Reading of Siemens Clinitest hCG Pregnancy Test Cassette, Manual Confirmatory Testing (Refractive Index). Three instruments/sites were used. If more than one instrument at a site, each was physically separate operator was used. Each site was instructed to run at minimum one 10-run. Data compared to the range/concentration determined for each level.
-
Single-Site Precision Study:
- Cellular instrument Study: Combined with Closed-Vial Stability study for UF-1000 and Arkray AU4050. Conducted per CLSI EP05-A3, Chapter 3. Three separately manufactured lots of control used on both instruments. Data collected internally at Streck. 20x2x2 model followed: two vials of control for each testing interval, each vial run in duplicate. Repeated for each lot and level. Data analyzed per CLSI EP05-A3 guidelines.
- Chemistry Instruments/Manual Methods Study: Three separately manufactured lots of control used. Data collected internally at Streck. 20x2x2 model followed: two vials of control for each testing interval, each vial run in duplicate. Completed for each lot and level. Data collected for Siemens CLINITEK Atlas, Siemens Status System Line, Arkray AUTION HYBRID AU-4050, Manual Reading of Siemens Multistix 10SG Reagent Strips, Manual Reading of Siemens Clinitest hCG Pregnancy Test Cassette, Manual Confirmatory Testing (Refractive Index).
-
Open-Vial Stability Study:
- Cellular Instrument Study: Conducted with three separately manufactured lots of control on UF-1000 and Arkray systems. One vial of control per level from each lot analyzed over 30 days plus one additional time point beyond. Data collected internally with one operator. Four replicates taken during each testing event.
- Chemistry Instrument Study: Conducted with three separately manufactured lots of control for each representative instrument/method. One vial of control per level from each lot analyzed over 30 days plus an additional time point. Day 0 is baseline. Last test point collected after stated stability claim. Four replicates taken during each testing event.
-
Closed-Vial Stability:
- Cellular instrument study: Conducted with three separately manufactured lots of control on UF-1000 and Arkray systems. Two vials of control per level from each lot analyzed in duplicate over 100 days plus one additional time point beyond 100 days. Four data points collected at each testing event. Data collected internally with one operator.
- Chemistry Instrument Study: Conducted with three separately manufactured for each representative instrument/method. One vial of control per level from each lot analyzed over 100 days plus an additional time point beyond. Day 0 is baseline. Last test point collected after stated stability claim. Four replicates taken during each testing event. Instruments utilized include Siemens CLINITEK Atlas, Siemens Status System Line, Arkray AUTION HYBRID AU-4050, Manual Reading of Siemens Multistix 10SG Reagent Strips, Manual Reading of Siemens Clinitest hCG Pregnancy Test Cassette, Manual Confirmatory Testing (Refractive Index).
Results:
- Data for the cellular study was determined to be acceptable if the mean of each run was within the acceptable range of control.
- Data for the chemistry study was considered acceptable if it was in agreement with the assigned range/concentration.
- All data collected fell within the acceptance criteria established for each instrument.
- Resultant data set established that UA-Cellular Complete is safe and effective for its intended use and that the product is stable for the entire product fulfills its intended use as instructed in the Instructions for Use.
- Study results show UA-Cellular Complete to be consistently equivalent to the predicate products, and stable for the entire product dating. UA-Cellular Complete is a safe and effective product, which fulfills its intended use when used as instructed in the Instructions for Use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
UA-Cellular Complete (K131444)
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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
February 9, 2017
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
STRECK DEBORAH KIPP REGULATORY AFFAIRS MANAGER 7002 S. 109TH STREET LA VISTA NE 68128
Re: K170091
Trade/Device Name: UA-Cellular® Complete Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: I, Reserved Product Code: JJW Dated: January 9, 2017 Received: January 10, 2017
Dear Deborah Kipp:
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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse 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.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 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/Resourcesfor You/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 yours.
Katherine Serrano -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
2
Indications for Use
510(k) Number (if known)
K170091
Device Name UA-Cellular^® Complete
Indications for Use (Describe)
UA-Cellular® Complete is an assayed chemistry and cellular urine control for evaluating the accuracy and precision of automated procedures that measure urinary sediment and chemistry parameters on the following instruments and testing methods: Sysmex® UF-1000i™ Automated Urine Particle Analyzer: Siemens® Clinitek Atlas Automated Urine Chemistry Analyzer utilizing the Clinitek Atlas 10 Reagent Pak; the Arkray AUTION HYBRID™ AU-4050 fullyautomated integrated urine analyzer: utilizing the Aution sticks 10EA Reagent strips: Siemens Clinitek Status® line of automated chemistry strip reader analyzers; Manual Reading of Urine Refractive Index; Manual Reading of the Siemens Multistix® 10SG Reagent Strips, and the Siemens Clinitest® hCG Pregnancy test.
The list of assayed parameters includes:
Sysmex^® UF-1000i™: RBC(/uL), WBC(/uL), Epithelial (/uL), Cast (/uL), Bacteria (/uL), Crystals
Arkray AU-4050: RBC(/uL), WBC(/uL), Epithelial (/uL), Cast (/uL), Bacteria (/uL), Crystals
Arkray AU-4050 with Aution sticks 10EA Reagent strips : Glucose (mg/dL), Bilirubin (As Measured), Ketones (mg/dL), Specific Gravity (As Measured), pH (As Measured), pH (As Measured), Protein (mg/dL), Urobilinogen (EU/dL), Nitrite (As Measured), Leukocytes (As Measured), Color (As Measured), Turbidity (As Measured)
Siemens ® Clinitek Atlas with Atlas 10 Reagent Pak: Glucose (mg/dL), Bilirubin (As Measured), Ketones (mg/dL), Specific Gravity (As Measured), Blood (As Measured), pH (As Measured), Protein (mg/dL), Urobilinogen (EU/dL), Nitrite (As Measured), Leukocytes (As Measured), Color (As Measured), Clarity (As Measured)
Siemens Clinitek Status System line with Multistix 10SG Reagent Strips: Glucose (mg/d); Bilirubin (As Measured), Ketones (mg/dL), Specific Gravity (As Measured), Blood (As Mesured), pH (As Measured), Protein (me/dL), Urobilinogen (EU/dL), Nitrite (As Measured), Leukocytes (As Measured)
Siemens Multistix 10SG Reagent Strips: Glucose (mg/dL), Bilirubin (As Measured), Specific Gravity (As Measured), Blood (As Measured), pH (As Measured), Protein (mg/dL), Urobilinogen (EU/dL), Nitrite (As Measured), Leukocytes (As measured)
Siemens Clinitest hCG Pregnancy Test Cassette: Pregnancy hCG (As Measured)
Manual Confirmatory Testing: Refractive Index (nD)
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.
3
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4
510(k) Summary
| 510(k) Submitter: | Streck
7002 South 109th Street
La Vista, NE 68128 |
|-------------------------|---------------------------------------------------------|
| Official Correspondent: | Deborah Kipp, Regulatory Affairs Manager |
| Address: | 7002 South 109th Street; La Vista, NE 68128 |
| Phone: | 402-537-5215 |
| Fax: | 402-537-5317 |
| Date Prepared: | December 31, 2016 |
| Names | |
| Trade Name: | UA-Cellular Complete |
| Common Name: | Quality Control Material (Assayed and Unassayed) |
| Classification Name: | Urinalysis Control |
| Product Code: | JJW (862.1660) |
| Panel: | Clinical Chemistry |
Predicate Device:
UA-Cellular Complete (K131444)
Intended Use:
UA-Cellular® Complete is an assayed chemistry and cellular urine control for evaluating the accuracy and precision of automated procedures that measure urinary sediment and chemistry parameters on the following instruments and testing methods: Sysmex "UF-1000" Automated Urine Particle Analyzer; Siemens® Clinitek Atlas Automated Urine Chemistry Analyzer utilizing the Clinitek Atlas 10 Reagent Pak; the Arkray AUTIQN HYBRID" AU-4050 fully-automated integrated urine analyzer; utilizing the Aution sticks 10EA Reagent strips; Siemens Clinitek Status" line of automated chemistry strip reader analyzers; Manual Reading of Urine Refractive Index; Manual Reading of the Siemens Multistix® 10SG Reagent Strips, and the Siemens Clinitest® hCG Pregnancy test.
The list of assayed parameters includes:
Sysmex® UF-1000i": RBC(/μL), WBC(/μL), Epithelial (/μL), Cast (μL), Bacteria (/μL), Crystals
Arkray AU-4050: RBC(/μL), WBC(/μL), Epithelial (/μL), Cast (/μL), Bacteria (/μL), Crystals
Arkray AU-4050 with Aution sticks 10EA Reagent strips : Glucose (ng/dL), Bilirubin (As Measured), Ketones (mg/dL), Specific Gravity (As Measured), Blood (As Measured), Protein (mg/dL), Urobilinogen (EU/dL), Nitrite (As Measured), Leukocytes (As Measured), Color (As Measured), Turbidity (As Measured)
Siemens® Clinitek Atlas with Atlas 10 Reagent Pak: Glucose (mg/dL), Bilirubin (As Measured), Ketones (mg/dL), Specific Gravity (As Measured), Blood (As Measured), pH (As Measured), Protein (mg/dL), Nitrite (As Measured), Leukocytes (As Measured), Color (As Measured), Clarity (As Measured)
Siemens Clinitek Status System line with Multisix 10SG Reagent Strips: Glucose (mg/dL); Bilirubin (As Measured), Ketones (mg/dL), Specific Gravity (As Measured), Blood (As Measured), Protein (mg/dL), Urobilinogen (EU/dL), Nititle (As Measured), Leukocytes (As Measured)
Siemens Multistix 10SG Reagent Strips: Glucose (mg/d), Bilirubin (As Measured), Ketones (mg/dL), Specific Gravity (As Measured), Blood (As Measured), pH (As Measured), Protein (mg/dL), Nitrite (As Measured), Leukocytes (As measured)
Siemens Clinitest hCG Pregnancy Test Cassette: Pregnancy hCG (As Measured)
Manual Confirmatory Testing: Refractive Index (nD)
5
Description:
UA-Cellular® Complete is a three-level, in-vitro diasis control that contains the following: stabilized mammalian red blood cells and white blood cells, stabilized bacteria, and simulative medium. Analyte levels are adjusted with appropriate chenicals. The product is packaged in a 4 oz. amber plastic bottle with a foil-lined flip-top cap. The product must be stored at 2-10°C.
Comparison to Predicate Device:
| Intended Use
Statement | UA-Cellular Complete (K131444)
Predicate Device | UA-Cellular Complete- Candidate Device | Same or Differences |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|---------------------|
| UA-Cellular Complete is an assayed
chemistry and cellular urine control for
evaluating the accuracy and precision
of automated procedures that measure
urinary sediment and chemistry
parameters on the Sysmex® UF-
1000i™ Automated Urine Particle
Analyzer and the Siemens® Clinitek
Atlas Automated Urine Chemistry
Analyzer utilizing the Clinitek Atlas 10
Reagent Pak. | UA-Cellular® Complete is an assayed chemistry and cellular urine control for evaluating the
accuracy and precision of automated procedures that measure urinary sediment and
chemistry parameters on the following instruments and testing methods: Sysmex® UF-1000i™
Automated Urine Particle Analyzer; Siemens® Clinitek Atlas Automated Urine Chemistry
Analyzer utilizing the Clinitek Atlas 10 Reagent Pak; the Arkray AUTION HYBRID™ AU-4050
fully-automated integrated urine analyzer; utilizing the Aution sticks 10EA Reagent strips;
Siemens Clinitek Status® line of automated chemistry strip reader analyzers; Manual Reading
of Urine Refractive Index; Manual Reading of the Siemens Multistix® 10SG Reagent Strips,
and the Siemens Clinitest® hCG Pregnancy test. | Addition of Arkray
AU-4050 | |
| The list of assayed parameters
includes: | The list of assayed parameters includes: | | |
| Sysmex UF-1000i: RBC(/μL),
WBC(/μL), Epithelial (/µL), Cast,
Bacteria (/μL), Crystals, Conductivity
(mS/cm) | Sysmex® UF-1000i:RBC(/μL), WBC(/μL), Epithelial (/μL), Cast (/μL), Bacteria (/μL), Crystals | Addition of Arkray AU-
4050 with Aution sticks
10EA Reagent Strips | |
| | Arkray AU-4050: RBC(/μL), WBC(/μL), Epithelial (/μL), Cast (/μL), Bacteria (/μL), Crystals | | |
| | Arkray AU-4050 with Aution sticks 10EA Reagent strips : Glucose (mg/dL), Bilirubin (As
Measured), Ketones (mg/dL), Specific Gravity (As Measured), Blood (As Measured), pH (As
Measured), Protein (mg/dL), Urobilinogen (EU/dL), Nitrite (As Measured), Leukocytes (As
Measured), Color (As Measured), Turbidity (As Measured) | Addition of Siemens
Clinitek Status System
line with Multistix 10SG
Reagent Strips | |
| Siemens Clinitek Atlas with Atlas 10
Reagent Pak: Glucose (mg/dL),
Bilirubin (As Measured), Ketones
(mg/dL), Specific Gravity (As
Measured), Blood (As Measured), pH
(As Measured), Protein (mg/dL),
Urobilinogen (EU/dL), Nitrite (As
Measured), Leukocytes (As
Measured), Color (As Measured),
Clarity (As Measured) | Siemens® Clinitek Atlas with Atlas 10 Reagent Pak: Glucose (mg/dL), Bilirubin (As Measured),
Ketones (mg/dL), Specific Gravity (As Measured), Blood (As Measured), pH (As Measured),
Protein (mg/dL), Urobilinogen (EU/dL), Nitrite (As Measured), Leukocytes (As Measured),
Color (As Measured), Clarity (As Measured) | Addition of Siemens
Multistix 10SG Reagent
Strips | |
| | Siemens Clinitek Status System line with Multistix 10SG Reagent Strips: Glucose (mg/dL);
Bilirubin (As Measured), Ketones (mg/dL), Specific Gravity (As Measured), Blood (As
Measured), pH (As Measured), Protein (mg/dL), Urobilinogen (EU/dL), Nitrite (As Measured),
Leukocytes (As Measured) | Addition of Siemens
Clinitest hCG Pregnancy
Test Cassette | |
| | Siemens Multistix 10SG Reagent Strips: Glucose (mg/dL), Bilirubin (As Measured), Ketones
(mg/dL), Specific Gravity (As Measured), Blood (As Measured), pH (As Measured), Protein
(mg/dL), Urobilinogen (EU/dL), Nitrite (As Measured), Leukocytes (As measured) | Addition of Manual
Confirmatory Testing-
Refractive Index | |
| | Siemens Clinitest hCG Pregnancy Test Cassette: Pregnancy hCG (As Measured) | Note: Conductivity will
now be included only for
use by Service personnel
only. | |
| | Manual Confirmatory Testing: Refractive Index (nD) | | |
6
| Open Vial
| Stability | 30 days | 30 days | Same |
|---|---|---|---|
| Closed Vial | |||
| Stability | 60 days | 100 days | Increase in Closed-Vial |
| Stability to 100 days | |||
| Reagents | Stabilized mammalian red blood cells | ||
| and white blood cells, stabilized | |||
| bacteria, and simulate urine sediments | |||
| in a preservative medium. Analyte | |||
| levels are adjusted with appropriate | |||
| chemicals. | Stabilized mammalian red blood cells and white blood cells, stabilized bacteria, and simulated | ||
| urine sediments in a preservative medium. Analyte levels are adjusted with appropriate | |||
| chemicals. | Same | ||
| Storage | |||
| Conditions | 2 - 10°C | 2 - 10°C | Same |
Discussion of Tests and Test Results:
To substantiate the product performance cares in the collected product performance data for the following studies: Multi-Ste Precision Study, Single-Site Precision Study, and Closed-Vial Stability, Throughout all tests, the product was stored in accordance with the IFU at the recommended temperature of 2 - 10°C. Specific details of each test are included below:
Multi-Site Precision Study
Two precision studies were executed for UA-Cellular complete. One for the cellular parameters and one for the qualitative and semi-quantitative instruments and methods that report values for the chemistry parameters.
Cellular Instrument Study
This nulti-site precision study was collected for the Arkry AU4050. This study was conducted per EP05-A3 across 3 instruments at three different sites. A single perator was used at each site ran each lot and level of control for 5 days, 2 runs per day, and 3 replicates per run.
Chemistry Instrument Study
This multi-site precision study was conducted utilizing the following chemistry instruments/manual methods:
- Siemens CLINITEK Atlas Utilizing the CLINITEK Atlas 10 Reagent Pak ●
- Siemens Status System Line Utilizing the CLINITEK Multistix 10SG Reagent Strips ●
- Arkray AUTION HYBRID AU-4050 Utilizing the AUTION Sticks 10EA Reagent Strips ●
- Manual Reading of the Siemens Multistix 10SG Reagent Strips
- Manual Reading of the Siemens Clinitest hCG Pregnancy Test Cassette ●
- Manual Confirmatory Testing (Refractive Index) ●
Three instrumentsisties were used. If there were than one instrument at a site, each was physically separate operator was used.
Each site was instructed to run at minimum one 10-run The data received was compared to the rangeloncentration determined for each level.
7
Single-Site Precision Study
Single site precision studies were conducted for the cellular and chemistry instruments/methods.
Cellular instrument Study
This study was combined with the Closed-Vial Stability study for both the UF-1000 and Arkray AU4050 instruments. The study was conducted per the guidelines contained in CLSI EP05-A3, Chapter 3, Single-Site Precision Evaluation Study.
This study was conducted with three separately manufactured lots of control on both the UF-1000i and Arkray AU4050. Data was collected internally at Streck. The 20x2x2 model was followed for this study. Two vials of control were used for each testing interval. Each vial of control was run in duplicate. The study was repeated for each lot and level of control. Data was analyzed per CLSI EP05-A3 quidelines.
Chemistry Instruments/Manual Methods Study
A single-site study was also conducted for all of the instruments and manual methods for the chemistry measurands. Three separately manufactured lots of control were used for this study. Data was collected internally at Streck. The 20x2x2 model was followed for this study. Two vials of control were used for each testing interval. Each vial of control was run in duplicate. The study was completed for each lot and level of control.
Data was collected for the following instruments:
- Siemens CLINITEK Atlas Utilizing the CLINITEK Atlas 10 Reagent Pak ●
- Siemens Status System Line Utilizing the CLINITEK Multistix 10SG Reagent Strips ●
- Arkray AUTION HYBRID AU-4050 Utilizing the AUTION Sticks 10EA Reagent Strips .
- Manual Reading of the Siemens Multistix 10SG Reagent Strips ●
- . Manual Reading of the Siemens Clinitest hCG Pregnancy Test Cassette
- . Manual Confirmatory Testing (Refractive Index)
Open-Vial Stability Study
An open-vial stability study was conducted for both the cellular and chemistry instrument methods. All studies were conducted real-time for the 30-day open-vial stability claim.
Cellular Instrument Study
This study was conducted with three separately manufactured lots of control on the UF-1000 and Arkray systems. One vial of control per level from each lot was analyzed over the 30-day open-vial stability plus one additional time point beyond the 30-day claim. Data was collected internally with one operator. Four replicates were taken during each testing event. Throughout the collection of the open-vial stability data each vial of control was stored in accordance with the IFU. Each vial was stored between 2° to 10°C and removed from the refrigerator for testing. After testing, the vial was returned to the refrigerator until the next testing event
This study was conducted with three separately manufactured lots of control for each representative instrument/method. One vial of control per level from each lot was analyzed over the 30-day open-vial stability plus an additional time point beyond the stated stability claim. Day 0 is the baseline value observed on the first day of the study. The last test point was collected after the stated open-vial stability claim to ensure that the claim was fully encompassed. Four replicates were taken during each testing event.
Data was collected utilizing the following instruments:
- Siemens CLINITEK Atlas Utilizing the CLINITEK Atlas 10 Reagent Pak ●
- Siemens Status System Line Utilizing the CLINITEK Multistix 10SG Reagent Strips ●
- . Arkray AUTION HYBRID AU-4050 Utilizing the AUTION Sticks 10EA Reagent Strips
- Manual Reading of the Siemens Multistix 10SG Reagent Strips ●
- Manual Reading of the Siemens Clinitest hCG Pregnancy Test Cassette ●
- . Manual Confirmatory Testing (Refractive Index)
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Throughout the collection of the open-vial stability data each vial of control was stored in accordance with the IFU. Each vial was stored between 2° to 10° C and removed from the refrigerator for testing, the vial was returned to the refrigerator until the next testing event.
Data for the cellular study was determined to be acceptable if the mean of each run was within the acceptable range of control. Data for the chemistry study was considered acceptable if it was in agreement with the assigned range/concentration. All data collected fell within the acceptance criteria established for each instrument.
Closed-Vial Stability
A closed-vial stability study was conducted for both the cellular and chemistry instrument methods. All studies were conducted real-time for the 100-day closed-vial stability claim.
Cellular instrument study
This study was conducted with three separately manufactured lots of control on the UF-1000 and Arkray systems. Two vials of control per level from each lot was analyzed in duplicate over the 100-day closed-vial stability plus one additional time point bevond 100 days. Four data points were collected at each testing event. Data was collected internally with one operator. Each vial was stored between 2° to 10° C and removed from the refrigerator for testing. After testing, the vial was returned to the refrigerator until the next testing event.
Chemistry Instrument Study
This study was conducted with three separately manufactured for each representative instrument/method. One vial of control per level from each lot was analyzed over the 100-day closed-vial stability plus an additional time point beyond the stated stability claim. Day 0 is the baseline value observed on the first day of the study. The last test point was collected after the stated closed-vial stability claim to ensure that the claim was fully encompassed. Four replicates were taken during each testing event.
The following instruments were utilized for this study:
- . Siemens CLINITEK Atlas Utilizing the CLINITEK Atlas 10 Reagent Pak
- . Siemens Status System Line Utilizing the CLINITEK Multistix 10SG Reagent Strips
- Arkray AUTION HYBRID AU-4050 Utilizing the AUTION Sticks 10EA Reagent Strips
- Manual Reading of the Siemens Multistix 10SG Reagent Strips
- . Manual Reading of the Siemens Clinitest hCG Pregnancy Test Cassette
- Manual Confirmatory Testing (Refractive Index)
Data for the cellular study was determined to be acceptable if the mean of each run was within the acceptable range of control. Data for the chemistry study was considered acceptable if it was in agreement with the assigned range/concentration. All data collected fell within the acceptance criteria established for each instrument.
The resultant data set established that UA-Cellular Complete is safe and effective for its intended use and that the product is stable for the entire product fulfills its intended use as instructed in the Instructions for Use.
Conclusions Drawn From Tests:
Study results show UA-Cellular Complete to be consistently equivalent to the predicate products, and stable for the entire product dating. UA-Cellular Complete is a safe and effective product, which fulfills its intended use when used as instructed in the Instructions for Use.