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.

The list of assayed parameters includes:

Sysmex UF-1000i:RBC(/μL), WBC//μL), Epithelial (/uL), Cast, Bacteria (/uL), Crystals, Conductivity (mS/cm)

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)

Device Description

UA-Cellular Complete is an in vitro diagnostic control prepared from 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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the UA-Cellular® Complete device:

The provided text describes UA-Cellular® Complete, a quality control material, and its performance studies. It is important to note that this device is a control material for other diagnostic devices, not a diagnostic device itself that processes patient data. Therefore, the "acceptance criteria" and "study" described are focused on substantiating the control material's stability, accuracy (value assignment), and precision when used with the specified automated urine analyzers. The typical metrics for AI systems (like sensitivity, specificity, AUC) are not applicable here.

Here's the breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this control material are implicitly derived from its intended use to evaluate the accuracy and precision of automated procedures. The "reported device performance" refers to the successful demonstration of these criteria.

Study Type	Acceptance Criteria	Reported Device Performance
Value Assignment	Assay data collected met the ±3 Standard Deviation requirements.	Data collected across three external sites and internally at Streck, using three separately manufactured lots. Each site provided a 10-run reproducibility study (n=40 per level). Four instruments and four operators were utilized. All data met the ±3 Standard Deviation requirements.
Open-Vial Stability	All values collected were within the assigned assay range.	Real-time data collected internally at Streck across three separately manufactured lots. One operator and one instrument for each type of analyzer were used. Values collected over the last 30 days of product dating were compared to Day 0 assayed values and were all within the assigned assay range.
Closed-Vial Stability	Data collected was within the documented assay ranges.	Verified using three separately manufactured lots, collected internally at Streck by one operator, using one instrument for each analyzer type. All data collected was within the documented assay ranges.
Precision Performance	All data for this study fell within the assigned assay values for the product.	Data collected at three external sites and internally at Streck across three separately manufactured lots. Each site provided a 10-run reproducibility study (n=40 per level). Four instruments and four operators were utilized. All data fell within the assigned assay values.

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

The concept of a "test set" as typically understood for an AI algorithm (a distinct dataset for final performance evaluation) doesn't directly apply here, as this is a control material. Instead, the studies involved collecting data on the performance of the control material.

Value Assignment and Precision Performance:
- Sample Size: Each of the three external sites and the internal Streck site performed a "10-run reproducibility study for the tri-level control on each lot (n=40 per level)". Given three lots and four sites, this would be: 3 lots * 4 sites * 40 runs/level = 480 data points per level for value assignment and precision. Since it's a tri-level control, the total number of individual runs would be 3 (levels) * 480 = 1440 runs.
- Data Provenance: Data was collected "across three external sites and data collected internally at Streck." The text does not specify the country of origin for the external sites, nor does it explicitly state if the data was retrospective or prospective, though "real-time" is mentioned for stability testing, suggesting prospective collection.
Open-Vial Stability and Closed-Vial Stability:
- Sample Size: Not explicitly stated as "n=X" in the same way as value assignment. However, data was collected "real time across three separately manufactured lots." and over "the last 30-days of product dating" for open-vial stability. For closed-vial, it was verified "utilizing three-separately manufactured lots." The sample size here refers to the number of measurements taken over time for each lot, but precise numbers are not given.
- Data Provenance: "All data was collected internally at Streck." This suggests the US. The "real-time" aspect indicates prospective data collection.

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

Ground truth concept for a control material: For a control material, the "ground truth" is not established by expert consensus on clinical findings, but rather by the assigned value range for each parameter, which is determined through a rigorous value assignment study.
Number of 'experts' / operators: The Value Assignment and Precision Performance studies each utilized "Four operators." While their specific qualifications (e.g., medical technologist, lab technician) are not stated, they are implied to be qualified laboratory personnel capable of operating the analyzers and performing reproducibility studies.

4. Adjudication Method for the Test Set

The concept of an "adjudication method" (like 2+1 or 3+1) is typically used when multiple human readers interpret an image or clinical finding to establish a consensus ground truth, especially for diagnostic AI applications. This is not applicable here as:

The device is a control material.
The "ground truth" (assigned values) are established through a statistical process (meeting ±3 Standard Deviation requirements) using instrumental measurements, not human interpretation requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This type of study assesses how AI assistance impacts human reader performance, which is not applicable to a quality control material.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

The device itself is a control material that works with automated analyzers. Its "performance" is inherently its interaction with the automated systems.

The studies described (Value Assignment, Stability, Precision) are effectively evaluating the standalone performance of the control material when run by the automated analyzers (without manual data adjustment or human decision-making influencing the measurement itself, beyond typical operational procedures). The "operators" are running the instruments, not interpreting the control material results to make a diagnosis or similar complex decision.

7. Type of Ground Truth Used

For the UA-Cellular® Complete control material, the "ground truth" for its performance is defined by:

Assigned Assay Range/Values: This is essentially a statistically determined target range or value for each parameter, established through robust multi-site, multi-lot studies (Value Assignment study) meeting specific statistical criteria (e.g., ±3 Standard Deviation requirements). This is a form of quantifiable reference value based on instrument measurement and statistical analysis.

8. Sample Size for the Training Set

The concept of a "training set" is not applicable here. This device is a physical control material, not an AI algorithm that is trained on data. The studies described are for validation and characterization of the control material's properties (stability, assigned values, precision) with specific predicate devices, not for training an algorithm.

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

As there is no "training set" for this control material, this question is not applicable.

Summary

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K13/444

JAN 2 9 2014

510(k) Summary

510(k) Submitter:

Streck 7002 South 109th Street Omaha, NE 68128

Official Correspondent: Address: Phone: Fax: Date Prepared:

Deborah Kipp, Requlatory Affairs Manager 7002 South 109th Street; Omaha, NE 68128 402-537-5215 402-537-5317 Revised: January 28, 2014

Names
Trade Name: Common Name: Classification Name: Product Code: Panel:

UA-Cellular® Complete Quality Control Material (Assayed and Unassayed) Urinalysis Control JJW (862.1660) Clinical Chemistry

Predicate Device:

Primary Predicate- MAS UA Control (K023928)

Secondary Predicate- Sysmex UF II CONTROL™-K080887 Note: This product was cleared with the 510(k) for the Sysmex UF-1000i instrument (K080887)

Intended Use:

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 Sysmex® UF-1000i™ Automated Urine Particle Analyzer and the Siemens® Clinitek Atlas Automated Urine Chemistry Analyzer utilizing the Clinitek Atlas 10 Reagent Pak.

The list of assayed parameters includes:

Sysmex UF-1000i:RBC(/μL), WBC//μL), Epithelial (/uL), Cast, Bacteria (/uL), Crystals, Conductivity (mS/cm)

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Description:

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Comparison to Predicate Device

	ControlUAMAS(K023928)-PrimaryPredicate	UFII Control (K080887)* -Secondary Predicate	UA-Cellular Complete
IntendedUse	MAS UA Control isintended for use in theclinical laboratory as acontrol for qualitative andsemi-quantitativeprocedures used in routineurinalysis testing. Assayvalues are provided for thespecific systems listed.The user can compareobservations with expectedranges as a means ofassuring consistentperformance of reagent andequipment. The product issuitable for use as a controlmaterial for physiochemical,chemical, and microscopicmethods of routineurinalysis. UA Control maybe used in conjunction withcommercially availableurine microscopic analysis	UF II CONTROL containscontrol particles for use inquality control mode of theSysmex Fully Automated UrineParticle Analyzer (UF-1000iand UF-500i) and FullyAutomated Integrated UrineAnalyzer (UX-2000)*Note-UFII Control Informationwas submitted with the 510(k)for the UF-1000i instrument.	UA-Cellular Complete is an assayed chemistry and cellularurine control for evaluating the accuracy and precision ofautomated procedures that measure urinary sediment andchemistry parameters on the Sysmex® UF-1000i™Automated Urine Particle Analyzer and the Siemens®Clinitek Atlas Automated Urine Chemistry Analyzer utilizingthe Clinitek Atlas 10 Reagent Pak.The list of assayed parameters includes:Sysmex UF-1000i:RBC(/μL), WBC(/μL), Epithelial (/µL),Cast, Bacteria (/µL), Crystals, Conductivity (mS/cm)Siemens Clinitek Atlas with Atlas 10 Reagent Pak: Glucose(mg/dL), Bilirubin (As Measured), Ketones (mg/dL), SpecificGravity (As Measured), Blood (As Measured), pH (AsMeasured), Protein (mg/dL), Urobilinogen (EU/dL), Nitrite(As Measured), Leukocytes (As Measured), Color (AsMeasured), Clarity (As Measured)Note: Alternate units are provided on the product assaysheet.

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	MAS(K023928)-PrimaryUAPredicate	UFII Control (K080887)* -Secondary Predicate		UA-Cellular Complete
AssayedParameters	Glucose(mg/dL);Bilirubin(AsMeasured), Ketones (AsMeasured), Specific Gravity(As Measured), Blood (AsMeasured), pH (AsMeasured), Protein (AsMeasured), UrobilinogenEU/dL), Nitrite (AsMeasured), Leukocyte (AsMeasured), Creatinine(mg/dL), Color (AsMeasured), Appearance (AsMeasured), Crystals (AsMeasured)	RBC (/μL), WBC (/μL),Epithelial Cells(/µL), Cast(/µL), Bacteria (/μL),Conductivity (mS/cm)		Sysmex UF-1000i:RBC(/μL), WBC(/µL), Epithelial (/µL),Cast, Bacteria (/µL), Crystals, Conductivity (mS/cm)Siemens Clinitek Atlas with Atlas 10 Reagent Pak: Glucose(mg/dL), Bilirubin (As Measured), Ketones (mg/dL), SpecificGravity (As Measured), Blood (As Measured), pH (AsMeasured), Protein (mg/dL), Urobilinogen (EU/dL), Nitrite(As Measured), Leukocytes (As Measured), Color (AsMeasured), Clarity (As Measured)
Open-VialStability				30 days
Closed-VialStability			6 weeks at 18-25°C3 months at 2-8°C	60 days
Reagents			2 years	Stabilized mammalian red blood cells and white blood cells,stabilized bacteria, and simulate urine sediments in apreservative medium. Analyte levels are adjusted withappropriate chemicals.
			UA Control is a liquid stablecontrol material preparedfrom human urine. Analytelevels are adjusted withvarious pure chemicals andhuman source materials.UA Control also containspreservatives andstabilizers.	Latex Control Particles
StorageConditions			2-8°C	2-10°C

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Discussion of Tests and Test Results:

To substantiate the product performance claims for UA-Cellular Complete on the Sysmex® UF-1000™ Automated Urine Particle Analyzer and Siemens® Clinitek Atlas Automated Urine Chemistry Analyzer utilizing the Clinitek Atlas 10 Reagent Pak, Streck collected product performance data for the following studies: Value Assignment, Open-Vial Stability, Closed-Vial Stability, and Precision Performance. Specific details reqarding each study are included below:

Value Assignment

Value Assignment for the UA-Cellular® Complete parameters was based on data collected across three external sites and data collected internally at Streck. Data was collected across three separately manufactured lots. Each site involved in testing provided a 10-run reproducibility study for the tri-level control on each lot (n=40 per level). Four instruments of the Siemens® Clinitek Atlas and Sysmex® UF-1000i™ were utilized to collect data. Four operators were used in the value assignment study. Assav data collected met the ±3 Standard Deviation requirements.

Open -Vial Stability

Open-vial stability testing was based on data collected real time across three separately manufactured lots. All data was collected internally at Streck utilizing one operator. A single instrument of the Siemens® Clinitek Atlas and Sysmex® UF-1000i™ were utilized to collect data. Data collection beqan on day 30 after the product release date. Values collected over the last 30-days of product dating were compared to the assayed values assigned on Day 0 before product release. All values collected were within the assigned assay range.

Closed-Vial Stability

The 60-day Closed-Vial Stability claim was verified utilizing three-separately manufactured lots of control. All data was collected internally at Streck utilizing one operator. A sinde instrument of the Siemens® Clinitek Atlas and Sysmex® UF-1000i™ were utilized to collect data. Data collected was within the documented assay ranges.

Precision Performance

Precision performance testing for UA-Cellular Complete was based on the data collected at three external sites and data collected internally at Streck. Data was collected across three separately manufactured lots. Each site provided a 10-run reproducibility study for the tri-level control (n=40 per level). Four instruments of the Siemens® Clinitek Atlas and Sysmex® UF-1000i™ were utilized to collect data, Four operators were used in the Precision Performance study. All data for this study fell within the assigned assay values for the product.

These tests established that UA-Cellular Complete is safe and effective for its intended use and that the product is stable for the entire product dating. The 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 reproducible, substantially 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.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is a stylized symbol that resembles a person with outstretched arms, with three wavy lines emanating from the figure.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 29, 2014

STRECK DEBORAH KIPP QUALITY ASSURANCE COORDINATOR 7002 SOUTH 109TH ST. OMAHA NE 68128

Re: K131444

Trade/Device Name: UA-Cellular Complete Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material Regulatory Class: I, reserved Product Code: JJW Dated: December 18, 2013 Received: December 19, 2013

Dear Ms. 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.

ff 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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Page 2-Ms. Kipp

If you desire specific advice for your device on our labeling regulations (2) CFR Parts 801 and 809), picase contact 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/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/Safetv/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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Courtney Jalias -S

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K131444

Device Name UA-Cellular® Complete

Indications for Use (Describe)

UA-Cellular Complete is an assayed chemistry and cellular urine control for accuracy and precision of automated procedures that measure urinary sediments on the Sysmex® UF-1000™ Automated Urine Particle Analyzer and the Siemens® Clinitek Atlas Automated Urine Chemistry Analyzer utilizing the Clinick Atlas 10 Reagent Pak.

The list of assayed parameters includes:

Sysmex UF-1000:RBC(/pL), WBC(/pL), Epithelial (/uL), Cast, Bacteria (/uL), Crystals, Conductivity (mS/cm)

Siemens Clinitek Atlas with Atlas 10 Reagent Pak: Glucose (mg/dL), Bilirubin (As Measured), Kecones (ng/dL), Specific Gravity (As Measured), Blood (As Measured), Protein (mg/dL), Urobilinogen (EU/dL), Nitrie (As Measured), Leukocytes (As Measured), Color (As Measured), Clarity (As Measured)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

FORM FDA 3881 (1/14)

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

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.