UA-Cellular for IQ is an assayed cellular urine control for evaluating the accuracy and precision of automated procedures that measure urinary sediment parameters.

Device Description

UA-Cellular for IQ is a urinalysis control which contains stabilized human red and white blood cells and other inert particles in a preservative medium. UA-Cellular for IQ is a urine control for the IRIS iQ® 200 analyzer. The product is packaged in plastic bottles containing 120ml. The closures are polypropylene screw caps with polyethylene liners. There are two different levels: level 1 and level 2. The bottles will be packaged in a box with the package insert / assay sheet. The product must be stored at 2 - 10° C.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

Device: UA-Cellular™ for IQ (Urinalysis Control)

A table of acceptance criteria and the reported device performance:

The document does not explicitly list "acceptance criteria" in a quantitative manner (e.g., "stability must be within X% of initial value"). Instead, the acceptance is implicitly tied to demonstrating performance (reproducibility and stability) that is "consistently reproducible, substantially equivalent to the predicate product and stable for the shelf life claimed."

Given the information provided, here's a table based on the claims and tested aspects:

Acceptance Criterion (Implicit)	Reported Device Performance
Reproducibility (Consistent Run-to-Run Performance)	Demonstrated consistent reproducibility.
Closed Vial Stability (Shelf Life)	Claimed: 60 days Demonstrated: Stable for a 60-day closed vial period. Results confirm lot-to-lot consistency.
Open Vial Stability	Claimed: 30 days Demonstrated: Stable for a 30-day open vial period.
Substantial Equivalence to Predicate Product (Cell-Chex Auto)	"All testing showed that UA-Cellular for IQ is ... substantially equivalent to the predicate product." While specific metrics for equivalence are not detailed, the implication is that its performance characteristics (reproducibility, stability) are comparable enough to warrant substantial equivalence according to FDA.
Evaluation of accuracy and precision of automated procedures	Intended for this purpose, and studies presumably confirmed its suitability, though specific data on this evaluation is not provided in a summarized form.

Sample size used for the test set and the data provenance:
- Sample Size for Test Set: The document mentions "Three types of studies were conducted," but does not specify the sample size (e.g., number of vials, number of runs, number of instruments) used for the Run-to-Run Reproducibility, Open Vial Stability, or Closed Vial Stability tests.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given the submitter's address (Omaha, NE, USA) and the context of a 510(k) submission, it is highly probable the studies were conducted in the United States and were prospective in nature, designed specifically to support the 510(k) application.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This device is a quality control material for automated urinalysis. The concept of "ground truth" established by experts (like radiologists for imaging) does not directly apply here. The "ground truth" for a control material is its formulated value and its performance over time against known stable parameters, measured by the automated system it's designed to control. The accuracy and precision of the automated procedures themselves are what the control then assesses. The document does not mention the use of experts to establish a "ground truth" for the control material itself. Its performance is measured empirically.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers interpret data, and discrepancies are resolved by an adjudicator. This document describes performance studies for a laboratory control material, not clinical interpretation by multiple readers.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a laboratory control material, not an AI-powered diagnostic device or a system designed to assist human readers. Therefore, an MRMC study and the concept of human reader improvement with AI assistance are irrelevant to this submission.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a physical control material, not an algorithm. Its performance is inherent to its formulation and stability characteristics when run on an automated instrument, which is by definition "standalone" in this context as it functions independently of human interpretation of its internal characteristics. Its purpose is to control the performance of an automated instrument.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For this type of device (a quality control material), the "ground truth" is typically established by:
- Formulation specifications: The known concentration and composition of stabilized cells and other particles introduced during manufacturing.
- Reference Method/Assay: The material's performance is likely measured against a highly accurate and precise reference method or instrument to establish its initial target values and assess its stability over time.
- Predicate Device Performance: Establishing "substantial equivalence" implies that the new device's performance aligns with the established performance characteristics of the predicate device (Cell-Chex Auto).
The document doesn't explicitly detail the specific reference methods or how the "ground truth" values for the control material's components were initially determined, but it would be based on validated analytical techniques.
The sample size for the training set:

Not applicable. This is a laboratory control material, not a machine learning model. Therefore, there is no "training set" in the context of AI/algorithms. The manufacturing process is designed and validated, but not "trained" in the AI sense.
How the ground truth for the training set was established:

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

Summary

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K090201

MAR 2 7 2009

510(k) Summary of Safety and Effectiveness

510(k) Submitter:	Streck7002 South 109th StreetOmaha, NE 68128
Official Correspondent:	Carol Thompson, Quality Assurance Manager(402)-537-5213
Date Prepared:	March 25, 2009
Name of Device:Trade Name:Common Name:Classification Name:	UA-Cellular™ for IQUrinalysis ControlHematology quality control mixture (864.8625)
Predicate Device:	Cell-Chex Auto (K053362) Manufactured by Streck

Description:

Intended Use:

UA-Cellular for IQ is an assayed cellular urine control for evaluating the accuracy and precision of automated procedures that measure urinary sediment parameters.

	Cell-Chex Auto (PredicateProduct)	UA-Cellular for IQ
Intended UseStatement	Cell-Chex Auto is an assayed wholeblood control for evaluating theaccuracy and precision ofhematology instruments thatmeasure blood cell counts in patientbody fluid samples.	UA-Cellular for IQ is an assayedcellular urine control for evaluatingthe accuracy and precision ofautomated procedures thatmeasure urinary sedimentparameters.
Open Vial Stability	30 days	Same
Closed VialStability	75 days	60 days
Reagents	Stabilized human red and whitecells	Same stabilized human red andwhite cells combined with non-squamous simulated epithelial andcrystal components
StorageConditions	2 - 10°C	Same

Comparison to Predicate Device:

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Discussion of Tests and Test Results:

Three types of studies were conducted to establish performance of UA-Cellular for IQ. The three tests conducted were Run-to-Run Reproducibility, Open Vial Stability and Closed Vial Stability. All testing showed that UA-Cellular for IQ is consistently reproducible, substantially equivalent to the predicate product and stable for the shelf life claimed.

Conclusions Drawn From Tests:

UA-Cellular for IQ is an assayed cellular urine control for evaluating the accuracy and precision of automated procedures that measure urinary sediment parameters. It meets the claim of a 60 day closed vial, and a 30 day open vial stability and consistent run-to-run performance. Reproducibility studies and Closed Vial stability results confirm lot-to-lot consistency in the manufacture of UA-Cellular for IQ. Customers can be assured of a reliable quality control material that meets their expectations.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or other bird with outstretched wings.

Public Health Service

MAR 2 7 2009

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Streck c/o Kerrie Oetter Quality Assurance Coordinator 7002 South 109th St. Omaha, Nebraska 68128

Re: K090201

Trade/Device Name: UA-Cellular™ for IQ Regulation Number: 21 CFR 864.8625 Regulation Name: Hematology Quality Control Mixture Regulatory Class: II Product Code: JPK Dated: January 26, 2009 Received: January 27, 2009

Dear Ms. Oetter:

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 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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the [kit/tray] have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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 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.

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Page 2- Ms. Oetter

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 Part 801); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on the labeling regulation, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at 240- 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For question regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR), please contact the Division of Surveillance Systems at 240-276-3464. You many obtain other general information on your responsibilities under the Act from the Division of Small Manufactuers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

for Maria M. Chan, Ph.D.
Director

Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety

Center for Devices and Radiological Health

Enclosure

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Indication for Use

510(k) Number (if known):

Device Name: UA-Cellular™ for IQ

Indication For Use:

UA-Cellular for IQ is an assayed cellular urine control for evaluating the accuracy and precision of automated procedures that measure urinary sediment parameters.

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Josephine Bautista

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

510(k) K09020/

Page 1 of 1

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Regulation Number and Section

§ 864.8625 Hematology quality control mixture.

(a)
Identification. A hematology quality control mixture is a device used to ascertain the accuracy and precision of manual, semiautomated, and automated determinations of cell parameters such as white cell count (WBC), red cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).(b)
Classification. Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.