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.

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)

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.

AI/ML Overview

The provided text describes the UA-Cellular® Complete device, a quality control material for urinalysis instruments, and studies performed to demonstrate its performance and stability.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a table format for each specific parameter (e.g., RBC count, glucose level). Instead, it describes acceptance as:

Cellular study: "acceptable if the mean of each run was within the acceptable range of control."
Chemistry study: "considered acceptable if it was in agreement with the assigned range/concentration."

The reported device performance is broadly stated as:

"All data collected fell within the acceptance criteria established for each instrument."
"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."

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

The studies primarily focus on precision and stability testing of the quality control material itself, rather than a clinical trial with patient samples as a "test set" in the typical sense for a diagnostic device.

Multi-Site Precision Study (Test Set equivalent for evaluating the QC material's performance):

Cellular Instrument Study (Arkray AU4050): Conducted across 3 instruments at three different sites. A single operator 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: Not explicitly stated as a number of samples but implied by the different instruments/methods used. "Each site was instructed to run at minimum one 10-run."
Data Provenance: Not explicitly stated as country of origin, but described as "Multi-Site," indicating data from multiple locations, likely within the US, given the FDA submission. The studies are prospective as they were conducted to substantiate the product performance.

Single-Site Precision Study:

Cellular Instrument Study (UF-1000 and Arkray AU4050): Conducted with three separately manufactured lots of control. The "20x2x2 model" was followed: Two vials of control were used for each testing interval, and each vial of control was run in duplicate. This means 20 days x 2 vials x 2 replicates = 80 measurements per lot/level. Data was collected internally at Streck.
Chemistry Instruments/Manual Methods Study: Conducted with three separately manufactured lots of control. The "20x2x2 model" was followed as above. Data was collected internally at Streck.
Data Provenance: Internally collected at Streck. Prospective.

Open-Vial Stability Study:

Cellular Instrument Study (UF-1000 and Arkray systems): Conducted with three separately manufactured lots of control. One vial of control per level from each lot was analyzed over 30 days plus one additional time point. Four replicates were taken during each testing event. Data was collected internally with one operator.
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 was analyzed over 30 days plus one additional time point. Four replicates were taken during each testing event.
Data Provenance: Internally collected at Streck. Prospective.

Closed-Vial Stability Study:

Cellular Instrument Study (UF-1000 and Arkray systems): Conducted with three separately manufactured lots of control. Two vials of control per level from each lot were analyzed in duplicate over 100 days plus one additional time point. Four data points were collected at each testing event. Data was 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 was analyzed over 100 days plus an additional time point. Four replicates were taken during each testing event.
Data Provenance: Internally collected at Streck. Prospective.

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

This device is a quality control material, not a diagnostic device that interprets patient data. Therefore, the concept of "ground truth" established by experts (like radiologists for image interpretation) for a "test set" of patient cases is not directly applicable.

Instead, the "ground truth" for this product is the assigned range/concentration of the analytes within the control material, determined by the manufacturer through rigorous characterization and validation processes not explicitly detailed in this summary (though typically involves reference methods and multiple testing events). The studies described here verify that the device performs within those pre-defined ranges.

4. Adjudication Method for the Test Set

Not applicable in the context of this type of device and study. The studies assess the control material's performance against its own established ranges/concentrations, not an interpretation of patient data requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers (e.g., radiologists) interpret cases, and the study aims to show how AI assistance affects their diagnostic performance compared to reading without AI. UA-Cellular® Complete is a quality control material used to assess the performance of laboratory instruments, not for direct human interpretation of patient data or for AI-assisted diagnostic tasks.

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

Yes, the studies described are essentially "standalone" in the sense that they evaluate the performance of the UA-Cellular® Complete material on automated instruments without active human interpretive intervention for each "case." The human role is in performing the tests according to protocols and analyzing the resulting quantitative data.

7. The Type of Ground Truth Used

The ground truth for these studies is the assigned range/concentration for each analyte (e.g., RBC, glucose, pH) within the UA-Cellular® Complete material, established by the manufacturer. The studies then demonstrate that the device, when run on various instruments, consistently produces results that fall within these pre-defined acceptable ranges. This is an intrinsic property of the quality control material itself, rather than an external reference standard like pathology or outcomes data from patients.

8. The Sample Size for the Training Set

This document describes performance and stability studies for a quality control material. It does not mention a "training set" in the context of machine learning or AI models. The device itself (UA-Cellular® Complete) is a physical control material, not an algorithm that requires training data.

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

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

Summary

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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.

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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

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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

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.

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510(k) Summary

510(k) Submitter:	Streck7002 South 109th StreetLa 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)

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Description:

Comparison to Predicate Device:

Intended UseStatement	UA-Cellular Complete (K131444)Predicate Device	UA-Cellular Complete- Candidate Device
UA-Cellular Complete is an assayedchemistry and cellular urine control forevaluating the accuracy and precisionof automated procedures that measureurinary sediment and chemistryparameters on the Sysmex® UF-1000i™ Automated Urine ParticleAnalyzer and the Siemens® ClinitekAtlas Automated Urine ChemistryAnalyzer utilizing the Clinitek Atlas 10Reagent Pak.	UA-Cellular® Complete is an assayed chemistry and cellular urine control for evaluating theaccuracy and precision of automated procedures that measure urinary sediment andchemistry parameters on the following instruments and testing methods: Sysmex® UF-1000i™Automated Urine Particle Analyzer; Siemens® Clinitek Atlas Automated Urine ChemistryAnalyzer utilizing the Clinitek Atlas 10 Reagent Pak; the Arkray AUTION HYBRID™ AU-4050fully-automated integrated urine analyzer; utilizing the Aution sticks 10EA Reagent strips;Siemens Clinitek Status® line of automated chemistry strip reader analyzers; Manual Readingof Urine Refractive Index; Manual Reading of the Siemens Multistix® 10SG Reagent Strips,and the Siemens Clinitest® hCG Pregnancy test.	Addition of ArkrayAU-4050
The list of assayed parametersincludes:	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 sticks10EA 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 (AsMeasured), Ketones (mg/dL), Specific Gravity (As Measured), Blood (As Measured), pH (AsMeasured), Protein (mg/dL), Urobilinogen (EU/dL), Nitrite (As Measured), Leukocytes (AsMeasured), Color (As Measured), Turbidity (As Measured)	Addition of SiemensClinitek Status Systemline with Multistix 10SGReagent Strips
Siemens Clinitek Atlas with Atlas 10Reagent Pak: Glucose (mg/dL),Bilirubin (As Measured), Ketones(mg/dL), Specific Gravity (AsMeasured), Blood (As Measured), pH(As Measured), Protein (mg/dL),Urobilinogen (EU/dL), Nitrite (AsMeasured), Leukocytes (AsMeasured), 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 SiemensMultistix 10SG ReagentStrips
	Siemens Clinitek Status System line with Multistix 10SG Reagent Strips: Glucose (mg/dL);Bilirubin (As Measured), Ketones (mg/dL), Specific Gravity (As Measured), Blood (AsMeasured), pH (As Measured), Protein (mg/dL), Urobilinogen (EU/dL), Nitrite (As Measured),Leukocytes (As Measured)	Addition of SiemensClinitest hCG PregnancyTest 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 ManualConfirmatory Testing-Refractive Index
	Siemens Clinitest hCG Pregnancy Test Cassette: Pregnancy hCG (As Measured)	Note: Conductivity willnow be included only foruse by Service personnelonly.
	Manual Confirmatory Testing: Refractive Index (nD)

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Open VialStability	30 days	30 days	Same
Closed VialStability	60 days	100 days	Increase in Closed-VialStability to 100 days
Reagents	Stabilized mammalian red blood cellsand white blood cells, stabilizedbacteria, and simulate urine sedimentsin a preservative medium. Analytelevels are adjusted with appropriatechemicals.	Stabilized mammalian red blood cells and white blood cells, stabilized bacteria, and simulatedurine sediments in a preservative medium. Analyte levels are adjusted with appropriatechemicals.	Same
StorageConditions	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.

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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)

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.

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.