(254 days)
Not Found
No
The device is a control material for calibrating and verifying the performance of automated urine analyzers. The description focuses on the composition and stability of the control material, not on any analytical or interpretive functions that would typically involve AI/ML. The performance studies described are standard validation procedures for control materials.
No
This device is an in vitro diagnostic control used to evaluate the accuracy and precision of automated procedures that measure urine parameters. It is not used to treat, cure, mitigate, or prevent disease.
No
This device is an in vitro diagnostic control used to evaluate the accuracy and precision of automated procedures that measure urinary sediment and chemistry parameters. It is not used to diagnose a patient.
No
The device description clearly states it 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." This describes a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "evaluating the accuracy and precision of automated procedures that measure urinary sediment and chemistry parameters." This is a classic function of an in vitro diagnostic control.
- Device Description: The description states it is an "in vitro diagnostic control."
- Function: The device is used to assess the performance of other in vitro diagnostic devices (the Sysmex UF-1000i and Siemens Clinitek Atlas). This is a key characteristic of an IVD control.
- Performance Studies: The document describes performance studies like Value Assignment, Open-Vial Stability, Closed-Vial Stability, and Precision Performance, which are typical studies conducted for IVD devices, particularly controls.
- Predicate Devices: The mention of predicate devices (MAS UA Control and Sysmex UF II CONTROL) which are also IVD controls further supports its classification as an IVD.
Therefore, based on the provided information, the UA-Cellular® Complete device is an In Vitro Diagnostic.
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 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)
Product codes
JJW
Device Description
UA-Callized bacera, an in viro digantit pe blowing stablized mammilian ed blockel will e blood elle and white blood elle, stablized baceria, annulated une sedine
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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
Value Assignment, Open-Vial Stability, Closed-Vial Stability, and Precision Performance.
Value Assignment: Data collected across three external sites and internally at Streck, across three manufactured lots. Each site provided a 10-run reproducibility study for tri-level control on each lot (n=40 per level). Four Siemens Clinitek Atlas and Sysmex UF-1000i instruments were used with four operators. Assay data met +/- 3 Standard Deviation requirements.
Open-Vial Stability: Data collected real time across three manufactured lots, internally at Streck, using one operator and one instrument of each type. Data collection began on day 30, with values compared to Day 0 assayed values. All values were within assigned assay range.
Closed-Vial Stability: Verified using three manufactured lots, internally at Streck, using one operator and one instrument of each type. Data was within documented assay ranges.
Precision Performance: Data collected at three external sites and internally at Streck, across three manufactured lots. Each site provided a 10-run reproducibility study for tri-level control (n=40 per level). Four Siemens Clinitek Atlas and Sysmex UF-1000i instruments were used with four operators. All data fell within assigned assay values.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
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)
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)
।
1
Description:
Description:
UA-Callized bacera, an in viro digantit pe blowing stablized mammilian ed blockel will e blood elle and white blood elle,
stablized baceria, annulated une sedine
Comparison to Predicate Device
| | Control
UA
MAS
(K023928)-Primary
Predicate | UFII Control (K080887)* -
Secondary Predicate | UA-Cellular Complete | |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Intended
Use | MAS UA Control is
intended for use in the
clinical laboratory as a
control for qualitative and
semi-quantitative
procedures used in routine
urinalysis testing. Assay
values are provided for the
specific systems listed.
The user can compare
observations with expected
ranges as a means of
assuring consistent
performance of reagent and
equipment. The product is
suitable for use as a control
material for physiochemical,
chemical, and microscopic
methods of routine
urinalysis. UA Control may
be used in conjunction with
commercially available
urine microscopic analysis | UF II CONTROL contains
control particles for use in
quality control mode of the
Sysmex Fully Automated Urine
Particle Analyzer (UF-1000i
and UF-500i) and Fully
Automated Integrated Urine
Analyzer (UX-2000)
*Note-UFII Control Information
was submitted with the 510(k)
for the UF-1000i instrument. | 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 (/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), 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)
Note: Alternate units are provided on the product assay
sheet. | |
| 4
2
| | MAS
(K023928)-Primary
UA
Predicate | Control | UFII Control (K080887)* -
Secondary Predicate | | UA-Cellular Complete | |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|--------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Assayed
Parameters | Glucose(mg/dL);
Bilirubin(As
Measured), Ketones (As
Measured), Specific Gravity
(As Measured), Blood (As
Measured), pH (As
Measured), Protein (As
Measured), Urobilinogen
EU/dL), Nitrite (As
Measured), Leukocyte (As
Measured), Creatinine
(mg/dL), Color (As
Measured), Appearance (As
Measured), Crystals (As
Measured) | | 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), 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) | |
| Open-Vial
Stability | | | | | 30 days | |
| Closed-Vial
Stability | | | | 6 weeks at 18-25°C
3 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 a
preservative medium. Analyte levels are adjusted with
appropriate chemicals. | |
| | | | | UA Control is a liquid stable
control material prepared
from human urine. Analyte
levels are adjusted with
various pure chemicals and
human source materials.
UA Control also contains
preservatives and
stabilizers. | Latex Control Particles | |
| Storage
Conditions | | | | 2-8°C | 2-10°C | |
.
ાર
3
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.
4
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.
5
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
6
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.