(224 days)
Not Found
Unknown
The summary mentions "imaging and evaluation software for analyzing the sediment pictures" and "image assessment," which are common applications for AI/ML in microscopy. However, it does not explicitly state that AI or ML is used, nor does it provide details about training or test sets that would definitively indicate AI/ML usage. The performance metrics are standard for analytical devices and don't specifically point to AI/ML.
No.
This device is an in vitro diagnostic (IVD) device used for analyzing urine samples in a laboratory setting, not for treating patients.
Yes
The device quantitatively and qualitatively determines various components in urine (erythrocytes, leukocytes, epithelial cells, bacteria, casts, crystals, yeasts, mucus, sperm), which are indicative of a patient's health status and used to inform diagnosis.
No
The device description explicitly lists multiple hardware components, including a rack transport system, liquid handling system, centrifuge, microscope, and camera system, in addition to the software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is intended for "in vitro quantitative determination of erythrocytes and leukocytes, the semi-quantitative determination of squamous epithelial cells, bacteria, and hyaline casts and the qualitative determination of non-squamous epithelial cells, crystals, yeasts, mucus and sperm in urine." This clearly indicates that the device is used to examine specimens (urine) taken from the human body to provide information for diagnostic purposes.
- Device Description: The description details a system that analyzes urine samples using microscopy and imaging to identify and quantify various components. This aligns with the nature of in vitro diagnostic devices.
- Clinical Laboratory Use: The intended user is "trained operators in clinical laboratories," which is a typical setting for IVD use.
- Performance Studies: The document includes detailed descriptions of performance studies, including method comparison against a reference method (manual microscopy), precision, detection limit, linearity, dilution, and interference studies. These types of studies are standard for demonstrating the performance and validity of IVD devices.
- Predicate Device: The mention of a predicate device (K022774; IRIS IQ 200) further supports its classification as an IVD, as predicate devices are used in the regulatory submission process for new IVDs.
All of these factors strongly indicate that the cobas u 701 microscopy analyzer is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The cobas u 701 microscopy analyzer is a fully automated urine microscopy system intended for the in vitro quantitative determination of erythrocytes and leukocytes, the semi-quantitative determination of squamous epithelial cells, bacteria, and hyaline casts and the qualitative determination of non-squamous epithelial cells, crystals, yeasts, mucus and sperm in urine.
This system is intended to be used by trained operators in clinical laboratories. All instrument analyte image decisions may be reviewed and reclassified by a trained operator.
Product codes
LKM
Device Description
The cobas u 701 microscopy analyzer is a fully automated urine analysis system optimized for the high-volume professional laboratory market, with a maximum theoretical throughput of up to 116 samples per hour. Its components include a rack transport system, liquid handling system, cuvette cassette compartment, centrifuge, built-in reverse microscope with movable objective lens, high resolution camera system, touch screen, and an inbuilt computer with imaging and evaluation software. Key functions include sample loading, transport, identification, homogenization, pipetting into cuvettes, centrifugation, image acquisition, image assessment, automatic disposal of used cuvettes, result readout, result and image memory, and optional manual classification/reclassification of particles. It runs on Microsoft Windows 10 and uses a Postgres/SQL database. The cobas u cuvette is a disposable used for sample processing, sold separately.
Mentions image processing
All images are evaluated by an image processing software which is able to detect and further classify the following urine particles
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Brightfield Microscopy (Inferred from "Built-in reverse microscope")
Anatomical Site
Urine
Indicated Patient Age Range
1 month - 98 years (for method comparison study samples)
Intended User / Care Setting
trained operators in clinical laboratories.
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
A total of 1310 samples were used across three studies.
Method Comparison Study: 689 clinical samples were analyzed against manual microscopy using KOVA slides as a comparator.
Reference Range Study: 621 "urine healthy" residual samples were measured to establish reference values for RBC and WBC.
Interferences: The same 1310 samples were used for evaluation of interferences.
The studies were executed at two European sites (Site 1, Site 2) and one site in the US (Site 3).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Evaluation:
- Precision: Repeatability and Intermediate Precision studies were performed according to CLSI EP5-A3.
- Repeatability: Assessed using control samples and human specimens at two sites. All predefined acceptance criteria were met.
- Intermediate Precision: Assessed long-term precision using control material (RBC, WBC) at two sites. All predefined acceptance criteria were met.
- Reproducibility: Quantitative parameters (WBC, RBC) were evaluated across three study sites using one cobas u 701 microscopy analyzer at each site.
- Recovery: Measurements for semi-quantitative parameters (BAC, HYA, SEC) were performed in triplicate at two sites, with manual KOVA counting method as comparison. All predefined acceptance criteria were met, showing exact agreement and agreement within 2 adjacent concentration ranges.
- Analytical Sensitivity:
- Limit of Blank (LoB): Determined as the 95th percentile of blank samples, meeting all predefined acceptance criteria.
- Limit of Detection (LoD): Determined as the lowest amount of analyte detectable with 95% probability, meeting all predefined acceptance criteria.
- Limit of Quantitation (LoQ): Defined as the lowest analyte concentration reproducibly measurable, meeting all predefined acceptance criteria.
- Linearity/Assay Reportable Range: For RBC and WBC, linearity was determined using CLSI EP6-A.
- Dilution: Performance with diluted samples was assessed. It is noted that dilution of urine is not advisable but results will be obtained with saline as diluent.
- Interferences: Assessed potential interferences from natural urine samples containing high concentrations of mucus strands, artifacts, clumps, cell fragments, dysmorphic cells, shining particles, crowded/viscous/turbid samples, amorphous crystals, and trichomonas.
- Assay Cut-Off Determination: Range limits set using empirical/theoretical information, clinical practice knowledge, and external study data.
External (Clinical) Testing:
- Total 1310 samples (689 for method comparison, 621 for reference range) from three sites (2 EU, 1 US).
- Method Comparison versus Reference Method (Manual Microscopy using KOVA slides):
- Sample Size: 689 samples across all sites. Age range: 1 month - 98 years.
- Quantitative Parameters (RBC, WBC): Passing-Bablok Regression Analysis showed strong correlation.
- RBC: Slope 1.00, Intercept -0.67, r=0.99, R2=0.97. Negative agreement 99%, Positive agreement 92%.
- WBC: Slope 0.98, Intercept -0.99, r=0.98, R2=0.97. Negative agreement 98%, Positive agreement 98%.
- Semi-quantitative Parameters (BAC, SEC, HYA): Cohen's Kappa, PPA, and NPA calculated.
- BAC: Cohen's Kappa 0.88, PPA 93% (LCL), NPA 95% (LCL).
- SEC: Cohen's Kappa 0.86, PPA 96% (LCL), NPA 97% (LCL).
- HYA: Cohen's Kappa 0.83, PPA 89% (LCL), NPA 97% (LCL).
- Qualitative Parameters (CRY, MUC, NEC, PAT, SPRM, YEA): Cohen's Kappa, NPA, PPA calculated.
- CRY: Cohen's Kappa 0.95, NPA 97% (LCL), PPA 98% (LCL).
- MUC: Cohen's Kappa 0.93, NPA 99% (LCL), PPA 94% (LCL).
- NEC: Cohen's Kappa 0.84, NPA 90% (LCL), PPA 94% (LCL).
- PAT: Cohen's Kappa 0.82, NPA 93% (LCL), PPA 89% (LCL).
- SPRM: Cohen's Kappa 0.89, NPA 95% (LCL), PPA 94% (LCL).
- YEA: Cohen's Kappa 0.88, NPA 97% (LCL), PPA 91% (LCL).
- Reference Range Study: Established reference values for RBC and WBC using 621 "urine healthy" residual samples across the three sites.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Quantitative Parameters (RBC, WBC) Agreement Rates:
RBC: Neg 99%, Pos 92%
WBC: Neg 98%, Pos 98%
Semi-Quantitative Parameters Agreement Rates (All sites, Cohen's Kappa, PPA (LCL), NPA (LCL)):
BAC: Cohen's Kappa 0.88, PPA 93%, NPA 95%
SEC: Cohen's Kappa 0.86, PPA 96%, NPA 97%
HYA: Cohen's Kappa 0.83, PPA 89%, NPA 97%
Qualitative Parameters Agreement Rates (Cohen's Kappa, PPA (LCL), NPA (LCL)):
CRY: Cohen's Kappa 0.95, NPA 97%, PPA 98%
MUC: Cohen's Kappa 0.93, NPA 99%, PPA 94%
NEC: Cohen's Kappa 0.84, NPA 90%, PPA 94%
PAT: Cohen's Kappa 0.82, NPA 93%, PPA 89%
SPRM: Cohen's Kappa 0.89, NPA 95%, PPA 94%
YEA: Cohen's Kappa 0.88, NPA 97%, PPA 91%
Predicate Device(s)
IRIS IQ 200 (K022774)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.5200 Automated cell counter.
(a)
Identification. An automated cell counter is a fully-automated or semi-automated device used to count red blood cells, white blood cells, or blood platelets using a sample of the patient's peripheral blood (blood circulating in one of the body's extremities, such as the arm). These devices may also measure hemoglobin or hematocrit and may also calculate or measure one or more of the red cell indices (the erythrocyte mean corpuscular volume, the mean corpuscular hemoglobin, or the mean corpuscular hemoglobin concentration). These devices may use either an electronic particle counting method or an optical counting method.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 6, 2020
Roche Diagnostics Teresa Carrow Regulatory Affairs Principal 9115 Hague Road Indianapolis, Indiana 46256
Re: K200811
Trade/Device Name: cobas u 701 microscopy analyzer Regulation Number: 21 CFR 864.5200 Regulation Name: Automated Cell Counter Regulatory Class: Class II Product Code: LKM Dated: March 26, 2020 Received: March 27, 2020
Dear Teresa Carrow:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Lea Carrington Division Director Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200811
Device Name cobas u 701 microscopy analyzer
Indications for Use (Describe)
The cobas u 701 microscopy analyzer is a fully automated urine microscopy system intended for the in vitro quantitative determination of erythrocytes and leukocytes, the semi-quantitative determination of squamous epithelial cells, bacteria, and hyaline casts and the qualitative determination of non-squamous epithelial cells, crystals, yeasts, mucus and sperm in urine.
This system is intended to be used by trained operators in clinical laboratories. All instrument analyte image decisions may be reviewed and reclassified by a trained operator.
| 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) |
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cobas u 701 microscopy analyzer 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
In accordance with 21 CFR 807.87, Roche Diagnostics hereby submits official notification as required by Section 510(k) of the Federal Food, Drug and Cosmetics Act of our intention to market the device described in this Premarket Notification 510(k).
The purpose of this Traditional 510(k) Premarket Notification is to obtain FDA review and clearance for the cobas u 701 microscopy analyzer.
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| Submitter Name | Roche Diagnostics |
|---|---|
| Address | 9115 Hague Road |
| P.O. Box 50416 | |
| Indianapolis, IN 46250-0457 | |
| Contact | Teresa Carrow |
| Phone: (317) 521-2963 | |
| FAX: (317) 521-2324 | |
| Email: teresa.carrow@roche.com |
Kelli Turner
Phone: (317) 521-4515
FAX: (317) 521-2324
Email: kelli.turner@roche.com |
| Date Prepared | September 2, 2020 |
| Proprietary Name | cobas u 701 microscopy analyzer
cobas u cuvette |
| Common Name | Automated urine microscopy system
cuvette for urine microscopy |
| Classification Name | Automated urine microscopy system
cuvette |
| Product Codes,
Regulation Numbers | See Table 1 |
| Predicate Devices | IRIS IQ 200 (K022774) |
| Establishment Registration | For the cobas u 701 microscopy analyzer the establishment registration number for
Roche Diagnostics GmbH Mannheim, Germany: 9610126
Roche Diagnostics GmBH Penzberg, Germany: 9610529
Roche Diagnostics Indianapolis, IN United States: 1823260. |
Table 1: Product Code and Regulation Number
The Urine Particle Counter is a Class II device under 21 CFR 864.5200.
| Device/Analyte | Product Code | Classification | Regulation | Panel |
|---|---|---|---|---|
| Urine Particle Counter | LKM | II | §864.5200 | Hematology |
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DEVICE DESCRIPTION 1.
| Component | Description |
|---|---|
| cobas u 701 microscopy analyzer | Instrument with external color touch panel |
| cobas u cuvette (400 cuvettes) | Cuvette cassette with 400 microscopy cuvettes |
| Racks | Standard rack, different types |
| Optional | |
| Waste box carton | Carton for easy disposal of used test strips |
| Connectivity | |
| Mouse | Alternative for touch screen input |
| Keyboard | Alternative for touch screen input |
| Printer | Commonly available laser printers |
| Host/LIS connectivity | ASTM standard |
| Data transfer | USB-stick |
The cobas u 701 microscopy analyzer consists of the following components:
cobas u 701 microscopy analyzer 1.1.
The cobas u 701 microscopy analyzer is a fully automated urine analysis system. It is optimized for the high-volume professional laboratory market. The cobas u 701 microscopy analyzer performs a maximum theoretical throughput of up to 116 samples per hour.
The cobas u 701 microscopy analyzer consists of several major components:
- Rack transport system o
- Liquid handling system o
- Cuvette cassette compartment o
- Centrifuge o
- Built-in reverse microscope with movable objective lens for focusing procedure o
- High resolution camera system o
- Touch Screen o
- Inbuilt Computer with the imaging and evaluation software for analyzing the sediment o pictures
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Key functions of the cobas u 701 microscopy analyzer include:
| Key Functions |
|---|
| Sample loading and transport |
| Sample identification |
| Sample homogenization |
| Sample pipetting into cuvettes |
| Centrifugation of cuvettes |
| Image acquisition with a camera |
| Image assessment |
| Automatic disposal of used cuvettes |
| Result readout |
| Result and image memory |
| Optional manual classification and / or re-classification of particles (manual entries are flagged) |
| Manual or Automatic validation of the result |
| Optional formats for data output including electronic result communication |
| Additional Functions |
| Data export |
| Remote Service |
| Quality Control (optional with RFID tagged controls) |
| Processing of diluted samples |
| Washing |
| Filling Water tank. Emptying liquid and solid waste |
The operating system will be Microsoft Windows 10. The system will use a Postgres/SQL database.
The cobas u 701 microscopy analyzer is a stand-alone system, and it is designed to be interconnected mechanically and electronically with the cobas u 601 Urine Analyzer in order to create a urine work area (cobas 6500). The cobas u 601 System was previously FDA-cleared under K183432. The connectivity to the cobas u 701 microscopy analyzer to form the cobas 6500 is not the subject of this submission.
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cobas u cuvette (400 cuvettes) 1.2.
The cobas u cuvette is used by the cobas u 701 microscopy analyzer to transport, centrifuge and analyze patient and control samples. They are provided separately from the analyzer, in a box holding 400 disposable cuvettes.
Calibrator 1.3.
No calibration of the device is necessary for its intended use. However, there is a microscope check, which is not a calibration of the device. This microscope check ensures proper functioning of the focusing mechanism of the microscope utilizing a reference cuvette.
The reference cuvette is a cuvette with the same dimensions as the sample cuvette, which contains a transparent material with a standardized number of erythrocyte like particles etched in it. For differentiation from the sample cuvettes, the reference cuyette is green and marked with the letter R on the top. This microscope check confirms that the instrument is able to focus accurately on the position of the particles and to count correctly the number of the cells. This microscope check needs to be performed every 4 weeks. A message from the instrument informs the operator when it is due.
INDICATIONS FOR USE 2.
cobas u 701 microscopy analyzer 2.1.
The cobas u 701 microscopy analyzer is a fully automated urine microscopy system intended for the in vitro quantitative determination of erythrocytes and leukocytes, the semi-quantitative determination of squamous epithelial cells, bacteria, and hyaline casts and the qualitative determination of non-squamous epithelial cells, crystals, yeasts, pathological casts, mucus and sperm in urine.
This system is intended to be used by trained operators in clinical laboratories. All instrument analyte image decisions may be reviewed and reclassified by a trained operator.
cobas u cuvette 2.2.
The cobas u cuvette is a cassette, containing cuvettes for the in vitro quantitative determination of erythrocytes and leukocytes, the semi-quantitative determination of squamous epithelial cells,
8
bacteria, and hyaline casts and the qualitative determination of non-squamous epithelial cells, crystals, yeasts, pathological casts, mucus, and sperm in urine with the cobas u 701 microscopy analyzer. For professional use only.
Note: For convenience, erythrocytes are referred to as RBC and leukocytes are referred to as WBC throughout this submission.
3. TECHNOLOGICAL CHARACTERISTICS
The following table compares the cobas u 701 microscopy analyzer with its predicate device, IRIS IQ 200 (K022774).
| Feature | Predicate Device | Candidate Device |
|---|---|---|
| IRIS IQ 200 (K022774) | cobas u 701 microscopy analyzer | |
| Intended Use | The iQ200 system is an in-vitrodiagnostic device used to automate thecomplete urinalysis profile, includingurine test strip chemistry panel andmicroscopic sediment analysis.Optionally, the iQ200 Analyzer can beused as a stand-alone unit, or theresults from the iQ200 Analyzer canbe combined with other urinechemistry results received from anLIS. It produces quantitative orqualitative counts of all formedsediment elements present in urine,including cells, casts, crystals andorganisms. A competent humanoperator can set criteria for auto-reporting and flagging specimens forreview.All instrument analyte imagedecisions may be reviewed andoverridden by a trained technologist. | The cobas u 701 microscopy analyzeris a fully automated urine microscopysystem intended for the in vitroquantitative determination oferythrocytes and leukocytes, the semi-quantitative determination ofsquamous epithelial cells, bacteria,and hyaline casts and the qualitativedetermination of non-squamousepithelial cells, crystals, yeasts,pathological casts, mucus and spermin urine. This system is intended to beused by trained operators in clinicallaboratories. All instrument analyteimage decisions may be reviewed andreclassified by a trained operator. |
| Submission | K022774 | N/A |
| Date Cleared | 21 October 2002 | N/A |
| Automation | Automated | Same |
| Feature | Predicate Device | |
| IRIS IQ 200 (K022774) | Candidate Device | |
| cobas u 701 microscopy analyzer | ||
| Specimen | Urine in barcode labeled tubes | Same |
| Change of | ||
| machine | ||
| assignment | All instrument analyte image | |
| decisions may be reviewed and | ||
| overridden by a trained technologist. | An appropriately trained laboratory | |
| operator may manually re-classify or | ||
| (sub-) sub-classify particles. | ||
| Principle of | ||
| Operation | The iQ200 System auto-identifies and | |
| processes barcoded tube | ||
| specimens in 10-position racks by | ||
| mixing, sampling, and analyzing | ||
| automatically. The iQ200 system | ||
| incorporates an iQ200 Automated | ||
| Urine Microscopy Analyzer, in which | ||
| a sample is presented as a lamina | ||
| sandwiched between enveloping | ||
| layers of suspending fluid to a | ||
| microscope coupled to a CCD (charge | ||
| coupling device) video camera. | ||
| This lamination positions the | ||
| specimen exactly within the depth of | ||
| focus and field of view of the | ||
| objective lens of the microscope. | ||
| Lamination is the planar equivalent of | ||
| axial hydrodynamic focusing, used to | ||
| position cells in certain types of blood | ||
| cell counters and flow cytometers. It | ||
| has the added advantage of achieving | ||
| orthoscopic particle orientation, | ||
| thereby presenting asymmetric | ||
| particles with their largest profile | ||
| facing the direction of view. | ||
| A CCD digital camera captures five | ||
| hundred frames per sample, as each | ||
| microscopic field of view is | ||
| illuminated by the flash of a strobe | ||
| lamp. The resulting pictures are | ||
| digitized and delivered to the Analysis | ||
| Processor computer. A previously | ||
| stored image of a blank background is | ||
| subtracted from the individual fields | ||
| of view, enhancing the morphology of | ||
| the captured particle. | ||
| Individual particle images are isolated | ||
| within each frame. The Auto- | The analyzer auto-identifies and | |
| processes barcoded tube specimens in | ||
| 5-position racks by mixing, sampling, | ||
| and analyzing automatically. | ||
| cobas u 701 microscopy analyzer | ||
| incorporates a robotic liquid handling | ||
| system that pipettes an aliquot of the | ||
| specimen into a disposable cuvette. | ||
| The filled cuvette is forwarded to the | ||
| built-in centrifuge for centrifugation | ||
| of the non-soluble particles. After the | ||
| centrifugation, all particles are brought | ||
| to one monolayer to ensure they are all | ||
| at the same focal plane. A built in | ||
| camera takes pictures through a built | ||
| in microscope at several positions of | ||
| the sediment. All images are evaluated | ||
| by an image processing software | ||
| which is able to detect and further | ||
| classify the following urine particles | ||
| • Red blood cells | ||
| • White blood cells | ||
| • Squamous epithelial cells | ||
| • Bacteria | ||
| • Hyaline casts | ||
| • Non-squamous epithelial cells | ||
| • Crystals | ||
| • Yeast | ||
| • Pathological casts | ||
| • Mucus | ||
| • Sperm | ||
| An appropriately trained laboratory | ||
| user may manually re-classify or sub- | ||
| classify particles on the basis of the | ||
| acquired pictures | ||
| Feature | Predicate Device | |
| IRIS IQ 200 (K022774) | Candidate Device | |
| cobas u 701 microscopy analyzer | ||
| Particle Recognition (APRTM) software, a highly trained neural network, uses size, shape, contrast and texture features to classify each image into one of 12 categories: RBCs, WBCs, WBC Clumps, Hyaline Casts, Unclassified Casts, Squamous Epithelial Cells, Non-squamous Epithelial Cells, Bacteria, Yeast, Crystals, Mucus and Sperm. Particle concentration is calculated using the number of images and the volume scanned. User-defined release criteria are checked and results are sent to an operator review screen or directly uploaded to the LIS based on these criteria. Specimen results can be edited, archived, retrieved, imported, exported and formatted into custom reports. | Particle concentration is calculated using the average count from the assessed images. | |
| Detected and | ||
| counted | ||
| particles | ||
| present in a | ||
| specimen | Red Blood Cells White Blood Cells White Blood Cell Clumps Non-Squamous Epithelial Cells Squamous Epithelial Cells Hyaline Casts Bacteria Crystals Yeast Artifact Unclassified Casts It is possible to manually sub classify Unclassified Crystals, Unclassified Casts, Yeast and Non-Squamous Epithelial Cells. | |
| It is possible to manually identify the following particles | Red blood cells White blood cells Squamous epithelial cells Bacteria Hyaline casts Non-squamous epithelial cells Crystals Yeast Pathological casts Mucus Sperm Not proposed | |
| It is possible to manually sub classify particles (e.g. RBC morphologies, CRY) | ||
| Sperm | It is possible to manually identify further particles (e.g. trichomonas, red | |
| Feature | Predicate Device | |
| IRIS IQ 200 (K022774) | Candidate Device | |
| cobas u 701 microscopy analyzer | ||
| • Mucus | blood cell clumps, oval fat bodies, | |
| artifacts.) | ||
| • Trichomonas | ||
| • Fat Red Blood Cell Clumps | ||
| • Oval Fat Bodies | ||
| QC | IQ Control material | Recommendation of commercially |
| available control solutions | ||
| Calibration | Monthly focus with iQ Focus and | |
| calibration with IQ® Calibrator | ||
| Material (suspension of fixed human | ||
| red blood cells in a particulate-free | ||
| solution) | No calibration needed due to different | |
| particle detection technology | ||
| Maintenance | Daily and periodic maintenance | Same |
| Specimen | ||
| Volume | Minimum volume 3 mL of un-spun | |
| urine. Aspiration volume approx. 1.3 | ||
| mL. | Minimum volume 2 mL of un-spun | |
| urine. Aspiration volume |