(90 days)
Not Found
No
The summary describes a standard automated clinical chemistry analyzer and associated reagent slides. There is no mention of AI or ML in the intended use, device description, or performance studies. The studies described are typical for validating the analytical performance of an in vitro diagnostic device.
No.
This device is an in vitro diagnostic device used to measure various analytes in biological fluids, which aids in diagnosis and monitoring, but it does not directly provide therapy or treatment.
Yes
The product description explicitly states, "For in vitro diagnostic use only," and describes its use in "diagnosis and treatment of renal diseases," "diagnosis and treatment of liver, hematological and metabolic disorders," and "measurement of a variety of analytes of clinical interest."
No
The device description clearly states it is a "fully automated, computer controlled, clinical chemistry and immunodiagnostic analyzer" and operates in conjunction with physical reagents, calibrators, and controls. This indicates it is a hardware system with integrated software, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The intended use statements for all listed products (VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, and the VITROS XT 7600 Integrated System) explicitly state "For in vitro diagnostic use only."
Furthermore, the device description clearly states that the VITROS XT 7600 Integrated System is "intended for the in vitro determination of a variety of general chemistries, therapeutic drugs, drugs of abuse, proteins, infectious diseases, as well as cardiac, metabolic, thyroid, anemia, and oncology markers in biological fluids such as serum, plasma, urine and cerebral spinal fluid." This aligns with the definition of an in vitro diagnostic device, which is used to examine specimens taken from the human body to provide information for the diagnosis, prevention, or treatment of disease.
N/A
Intended Use / Indications for Use
-
VITROS Chemistry Products CRBM Slides: Rx Only. For in vitro diagnostic use only. VITROS Chemistry Products CRBM Slides quantitatively measure carbamazepine (CRBM) concentration in serum and plasma using VITROS 250/350/950/5.1 FS and 4600 Chemistry Systems and the VITROS 5600/ XT 7600 Integrated System. Measurements obtained are used in monitoring levels of carbamazepine to help ensure appropriate therapy.
-
VITROS Chemistry Products CREA Slides: Rx Only. For in vitro diagnostic use only. VITROS Chemistry Product CREA Slides quantitatively measure creatinine (CREA) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600/ XT 7600 Integrated System. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
-
VITROS Chemistry Products TBIL Slides: Rx Only. For in vitro diagnostic use only. VITROS Chemistry Products TBIL Slides quantitatively measure total bilirubin (TBIL) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600/ XT 7600 Integrated System. Measurements of the levels of bilirubin are used in the diagnosis and treatment of liver, hematological and metabolic disorders, including hepatitis and gall bladder block.
-
VITROS XT 7600 Integrated System: Rx Only. For in vitro diagnostic use only. The VITROS XT 7600 Integrated System is intended for use in the measurement of a variety of analytes of clinical interest.
Product codes (comma separated list FDA assigned to the subject device)
JFY, KLT, CIG, JJE
Device Description
The VITROS XT 7600 Integrated System is a fully automated, computer controlled, clinical chemistry and immunodiagnostic analyzer intended for the in vitro determination of a variety of general chemistries, therapeutic drugs, drugs of abuse, proteins, infectious diseases, as well as cardiac, metabolic, thyroid, anemia, and oncology markers in biological fluids such as serum, plasma, urine and cerebral spinal fluid. The System operates in conjunction with reagents, calibrators and controls designed for use with the System in the MicroSlide, MicroTip or MicroWell format.
The VITROS Chemistry MicroSlide range of products (in this case VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, and VITROS Chemistry Products TBIL Slides), are combined with the VITROS XT 7600 Integrated System to perform the VITROS CRBM, CREA, and TBIL assays.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Method comparison studies were conducted by testing a minimum of 116 human serum samples with analyte concentrations across the analytical ranges of carbamazepine, creatinine and total bilirubin assays on the VITROS XT 7600 Integrated System and the VITROS 5600 Integrated System (predicate device). In addition, 125 human urine samples were tested for creatinine on the candidate and predicate test systems.
Precision studies were conducted by testing a minimum of two Quality control fluids and three human based precision fluids using the Carbamazepine (CRBM), Creatinine (CREA), and Total Bilirubin (TBIL) assays. Samples were analyzed using one VITROS XT 7600 Integrated System over 20 days, with 2 runs per day and 2 replicates per specimen (n=80).
Linearity studies were performed using a series of eleven proportionally related admixtures of low and high test fluids, with each sample tested in triplicate (a minimum of two replicates was acceptable for analysis) for VITROS CRBM Slides, VITROS CREA Slides, and VITROS TBIL Slides on the VITROS XT 7600 Integrated System.
Detection capability studies were performed. Limit of blank (LoB) studies were performed by testing 4 blank samples. Samples were tested in replicates of 6 over 3 days, using 3 lots of reagents, 4 samples every day, for a total of 216 observations (72 results per reagent lot). Limit of detection (LoD) studies were performed by testing 4 pools of human samples with analyte concentrations close to the expected detection limit for each analyte. Samples were tested in replicates of 6 over 3 days, using 3 lots of reagents, with the 4 human sample pools every day. for a total of 216 observations (72 results per reagent lot). Limit of Quantitation studies were performed using 4 pools of low level samples with analyte concentrations close to the expected LoQ of the corresponding assay. Samples were tested in replicates of 4 over 3 days, using 3 lots of reagents, 4 samples every day, for a total of 144 observations (48 results per reagent lot).
Interference Testing was performed using VITROS CRBM, VITROS CREA and VITROS TBIL assays on one VITROS XT 7600 Integrated System and one VITROS 5600 Integrated System. Testing included known chemical interferents, common chemical substances, and several claimed non-interferents. The results demonstrated acceptable bias for currently claimed interferents. One new interfering substance, Tolazamide on CREA(s) MicroSlides, was identified.
Key results tables are provided for Method Comparison, Precision, and Detection Limits.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Slope, Intercept, Test range, Claimed Measuring Range, SD, %CV, LoB, LoD, LoQ.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K160495, K063591, K840880, K081543
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1225 Creatinine test system.
(a)
Identification. A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
October 30, 2018
Ortho-Clinical Diagnostics, Inc. Marlene Hanna Director, Regulatory Affairs 100 Indigo Creek Drive Rochester, NY 14626
Re: K182063
Trade/Device Name: VITROS Chemistry Products CRBM Slides VITROS Chemistry Products CREA Slides VITROS Chemistry Products TBIL Slides VITROS XT 7600 Integrated System Regulation Number: 21 CFR 862.1225 Regulation Name: Creatinine test system Regulatory Class: Class II Product Code: JFY, KLT, CIG, JJE Dated: July 30, 2018 Received: August 1, 2018
Dear Marlene Hanna:
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.
1
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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) 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 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Kellie B. Kelm -S
for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182063
Device Name VITROS Chemistry Products CRBM Slides VITROS Chemistry Products CREA Slides VITROS Chemistry Products TBIL Slides VITROS XT 7600 Integrated System
Indications for Use (Describe)
-
VITROS Chemistry Products CRBM Slides: Rx Only. For in vitro diagnostic use only. VITROS Chemistry Products CRBM Slides quantitatively measure carbamazepine (CRBM) concentration in serum and plasma using VITROS 250/350/950/5.1 FS and 4600 Chemistry Systems and the VITROS 5600/ XT 7600 Integrated System. Measurements obtained are used in monitoring levels of carbamazepine to help ensure appropriate therapy.
-
VITROS Chemistry Products CREA Slides: Rx Only. For in vitro diagnostic use only. VITROS Chemistry Product CREA Slides quantitatively measure creatinine (CREA) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600/ XT 7600 Integrated System. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
-
VITROS Chemistry Products TBIL Slides: Rx Only. For in vitro diagnostic use only. VITROS Chemistry Products TBIL Slides quantitatively measure total bilirubin (TBIL) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600/ XT 7600 Integrated System. Measurements of the levels of bilirubin are used in the diagnosis and treatment of liver, hematological and metabolic disorders, including hepatitis and gall bladder block.
-
VITROS XT 7600 Integrated System: Rx Only. For in vitro diagnostic use only. The VITROS XT 7600 Integrated System is intended for use in the measurement of a variety of analytes of clinical interest.
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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3
5 510(k) Summary Information
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K182063
Submitter's Information
Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101 Phone: (585) 453-4041 Fax: (585) 453-3368
Contact Person:
Marlene Hanna, RAC Director, Regulatory Affairs
Date of Preparation: July 30, 2018
Device Proprietary Name(s):
VITROS Chemistry Products CRBM Slides VITROS Chemistry Products CREA Slides VITROS Chemistry Products TBIL Slides VITROS XT 7600 Integrated System
Common Names:
Carbamazepine assay Creatinine assay Total bilirubin assay Clinical chemistry analyzer
Classification Names
| VITROS | Product Code | Class | Regulation Section | Panel |
|---|---|---|---|---|
| CRBM | KLT | Class II | 21 CFR 862.3645 Neuroleptic drugs radioreceptor assay test system. | Clinical Toxicology |
| CREA | JFY | Class II | 21 CFR 862.1225 creatinine test system | Clinical Chemistry |
| TBIL | CIG | Class II | 21 CFR 862.1110 Bilirubin (total or direct) test system. | Clinical Chemistry |
| XT 7600 | JJE | Class I | 21 CFR 862.2160 Discrete photometric chemistry analyzer for clinical use | Clinical Chemistry |
4
Predicate Device(s)
| No. | New Devices | Predicate Devices | Predicate Device
FDA 510(k)
Number |
|-----|------------------------------------------|------------------------------------------|------------------------------------------|
| 1 | VITROS Chemistry
Products CRBM Slides | VITROS Chemistry
Products CRBM Slides | K160495 |
| 2 | VITROS Chemistry
Products CREA Slides | VITROS Chemistry
Products CREA Slides | K063591 |
| 3 | VITROS Chemistry
Products TBIL Slides | VITROS Chemistry
Products TBIL Slides | K840880 |
| 4 | VITROS XT 7600
Integrated System | VITROS 5600
Integrated System | K081543 |
Intended Use Statement(s)
1. VITROS Chemistry Products CRBM Slides
Rx Only. For in vitro diagnostic use only. VITROS Chemistry Products CRBM Slides quantitatively measure carbamazepine (CRBM) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600/ XT 7600 Integrated System. Measurements obtained are used in monitoring levels of carbamazepine to help ensure appropriate therapy.
2. VITROS Chemistry Products CREA Slides
Rx Only. For in vitro diagnostic use only. VITROS Chemistry Product CREA Slides quantitatively measure creatinine (CREA) concentration in serum, plasma, and urine using VITROS 250/350/950/5.1 FS and 4600 Chemistry Systems and the VITROS 5600/ XT 7600 Integrated System. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
3. VITROS Chemistry Products TBIL Slides
Rx Only. For in vitro diagnostic use only. VITROS Chemistry Products TBIL Slides quantitatively measure total bilirubin (TBIL) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600/ XT 7600 Integrated System. Measurements of the levels of bilirubin are used in the diagnosis and treatment of liver, hemolytic hematological and metabolic disorders, including hepatitis and gall bladder block.
4. VITROS XT 7600 Integrated System
Rx Only. For in vitro diagnostic use only. The VITROS XT 7600 Integrated System is intended for use in the measurement of a variety of analytes of clinical interest.
5
Device Description
The VITROS XT 7600 Integrated System is a fully automated, computer controlled, clinical chemistry and immunodiagnostic analyzer intended for the in vitro determination of a variety of general chemistries, therapeutic drugs, drugs of abuse, proteins, infectious diseases, as well as cardiac, metabolic, thyroid, anemia, and oncology markers in biological fluids such as serum, plasma, urine and cerebral spinal fluid. The System operates in conjunction with reagents, calibrators and controls designed for use with the System in the MicroSlide, MicroTip or MicroWell format.
The VITROS Chemistry MicroSlide range of products (in this case VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, and VITROS Chemistry Products TBIL Slides), are combined with the VITROS XT 7600 Integrated System to perform the VITROS CRBM, CREA, and TBIL assays.
Comparison to Predicate Devices
The following tables show similarities and differences between the new and predicate devices.
| Similarities | ||
|---|---|---|
| Device | ||
| Characteristic | Candidate | |
| VITROS CRBM Slides | Predicate Device | |
| VITROS CRBM | ||
| Slides | ||
| K160495 | ||
| Intended Use | Rx Only. For in vitro diagnostic | |
| use only. VITROS Chemistry | ||
| Products CRBM Slides | ||
| quantitatively measure | ||
| carbamazepine (CRBM) | ||
| concentration in serum and plasma. | Same | |
| Basic principle | Multiple-point Immunorate | Same |
| Reactive | ||
| Ingredients | ||
| per cm2 | Immobilized mouse monoclonal | |
| anti-carbamazepine antibody | ||
| 0.02 mg; carbamazepine- | ||
| horseradish peroxidase conjugate | ||
| 1.6 ng; and 2-(3,5-dimethoxy-4- | ||
| hydroxyphenyl)-4,5-bis(4- | ||
| dimethylaminophenyl) imidazole | ||
| (leuco dye) 0.02 mg. | Same | |
| Wavelength | 670 nm, 540 nm is also used for wash | |
| detection | Same | |
| Sample type | Serum and plasma | Same |
| Sample volume | 11 μL | Same |
Table 1 VITROS Chemistry Products CRBM Slides
6
| Differences | ||
|---|---|---|
| Device | ||
| Characteristic | Candidate | |
| VITROS CRBM Slides | Predicate Device | |
| VITROS CRBM | ||
| Slides | ||
| K160495 | ||
| Instrumentation | VITROS 250/350/950/5,1 FS and | |
| 4600 Chemistry Systems and the | ||
| VITROS 5600/ XT 7600 Integrated | ||
| System | VITROS | |
| 250/350/950/5,1 FS and | ||
| 4600 Chemistry | ||
| Systems and the | ||
| VITROS 5600 | ||
| Integrated System |
Table 2 VITROS Chemistry Products CREA Slides
| Similarities | ||
|---|---|---|
| Device | ||
| Characteristic | Candidate | |
| VITROS CREA Slides | Predicate Device | |
| VITROS CREA Slides | ||
| K063591 | ||
| Intended Use | Rx Only. For in vitro diagnostic | |
| use only. VITROS Chemistry | ||
| Product CREA Slides | ||
| quantitatively measure creatinine | ||
| (CREA) concentration in serum, | ||
| plasma, and urine. | Same | |
| Basic principle | Two-point rate | Same |
| Reactive | ||
| Ingredients | ||
| per cm2 | Creatinine amidohydrolase | |
| (Flavobacterium sp.) 0.20 U; creatine | ||
| amidinohydrolase (Alcaligenes sp.) 3.6 | ||
| U; sarcosine oxidase (Bacillus sp.) | ||
| 0.55 U; peroxidase (horseradish root) | ||
| 1.6 U and 2- (3,5-dimethoxy-4- | ||
| hydroxyphenyl)-4,5-bis(4- | ||
| dimethylaminophenyl) imidazole | ||
| (leuco dye) 32 μg. | Same | |
| Wavelength | 670 nm | Same |
| Sample type | Serum, plasma, urine | Same |
| Sample volume | 6 μL | Same |
| Differences | ||
|---|---|---|
| Device | ||
| Characteristic | Candidate | Predicate Device |
| VITROS CREA Slides | VITROS CREA Slides | |
| K063591 |
7
| Instrumentation | |
|---|---|
| VITROS 250/350/950/5,1 FS and | |
| 4600 Chemistry Systems and the | |
| VITROS 5600/ XT 7600 Integrated | |
| System | VITROS |
| 250/350/950/5,1 FS and | |
| 4600 Chemistry | |
| Systems and the | |
| VITROS 5600 | |
| Integrated System |
Table 3 VITROS Chemistry Products TBIL Slides
| Similarities | ||
|---|---|---|
| Device | ||
| Characteristic | Candidate | |
| VITROS TBIL Slides | Predicate Device | |
| VITROS TBIL | ||
| Slides | ||
| K840880 | ||
| Intended Use | Rx Only. For in vitro diagnostic use only. VITROS Chemistry Products TBIL Slides quantitatively measure total bilirubin (TBIL) concentration in serum and plasma. | Same |
| Basic principle | Dual wavelength endpoint | Same |
| Reactive | ||
| Ingredients | ||
| per cm2 | Dyphylline 0.5 mg and 4-(N-carboxymethylaminosulfonyl) benzene diazonium hexafluorophosphate 57 µg. | Same |
| Wavelength | measured at 2 wavelengths, 460 and 540nm | Same |
| Sample type | Serum and plasma | Same |
| Sample volume | 10 µL | Same |
| Device
Characteristic | Candidate
VITROS TBIL Slides | Predicate Device
VITROS TBIL
Slides K840880 |
|--------------------------|--------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| Instrumentation | VITROS 250/350/950/5,1 FS and
4600 Chemistry Systems and the
VITROS 5600/ XT 7600 Integrated
System | VITROS
250/350/950/5,1 FS
and 4600 Chemistry
Systems and the
VITROS 5600
Integrated System |
Table 4 VITROS XT 7600 Integrated System
| Similarities | ||
|---|---|---|
| Device | ||
| Characteristic | Candidate | |
| VITROS XT 7600 System | Predicate Device | |
| VITROS 5600 | ||
| System | ||
| K081543 | ||
| Similarities | ||
| Device | ||
| Characteristic | Candidate | |
| VITROS XT 7600 System | Predicate Device | |
| VITROS 5600 | ||
| System | ||
| K081543 | ||
| System Features | ||
| Intended use | For use in the in vitro quantitative, semi- | |
| quantitative, and qualitative | ||
| measurement of a variety of analytes of | ||
| clinical interest, using VITROS | ||
| Chemistry Products Slides, VITROS | ||
| Chemistry Products MicroTip Reagents | ||
| and VITROS Immunodiagnostic | ||
| Products Reagents. | No change | |
| Fundamental | ||
| scientific | ||
| technology | MicroSlides - Colorimetric, | |
| Potentiometric, enzymatic endpoint and | ||
| Immunorate assays. |
MicroTip and MicroWell reagents
The analyzer uses four main detection
systems:
- Reflection densitometry for
colorimetric and Immunorate
VITROS MicroSlides. - Transmission spectrophotometry
for VITROS MicroTip assays. - Enhanced chemiluminescent
detection for VITROS MicroWell
assays. - Electrometer for VITROS
MicroSlide ion-selective electrode
(ISE) assays. | No change |
| Operating
principle | Sample programming, sampling
processing, result calculation, result
reporting | No change |
| Modes of
operation | Continuous, Random, STAT | No change |
| Throughput | 845 tests per hour | No change |
| User interface | Touch screen (17 inch monitor),
keyboard, ADD | No change |
| Sample and
reagent volume
verification | Verification to ensure sufficient quantity
of sample and reagent to run requested
assays | No change |
| On-Board
Dilution Range | Dilution factor of 1: 400 | No change |
| Predictive alerts
through
eConnectivity | The predictive alerts are logged and are
electronically sent to the equipment
service group real time for monitoring. | No change |
| Similarities | | |
| Device
Characteristic | Candidate
VITROS XT 7600 System | Predicate Device
VITROS 5600
System
K081543 |
| (remote access)
Lab Information
System (LIS) | Enabled | No change |
| VAS Lab
Automation
System (LAS) | Enabled | No change |
| Specimen Sampling and Handling | | |
| Specimen type | Serum, Plasma, Urine, CSF, Whole
Blood | No change |
| Specimen
containers | Cups, Primary Sample Collection Tubes | No change |
| Identification | Manual entry or Bar Code | No change |
| Specimen
handling | Universal Sample Tray | No change |
| Specimen
processing | Auto-dilution, repeat and reflex
capabilities | No change |
| Automation
capabilities:
10.25 mm tube
for pediatric
samples | Supported | No change |
| Sample Quality
Monitoring
(hemolysis,
icterus and
turbidity) | Yes | No change |
| Calibration | | |
| Calibrators | MicroSlide and MicroTip: analyte
specific and multiple analytes
MicroWell: analyte specific | No change |
| Identification | MicroSlide and MicroWell: Bar Code or
manual entry
MicroTip: Manual entry | No change |
| Calibration
Programming
Frequency | Sample tray can contain Calibrators, QC
samples and/or patient samples
According to the assay Instructions for
Use | No change |
| Calibration
Completion
Time
Monitoring | Tracking time until calibration
completion is displayed to the operator. | No change |
| Similarities | | |
| Device
Characteristic | Candidate
VITROS XT 7600 System | Predicate Device
VITROS 5600
System
K081543 |
| Controls | MicroSlide and MicroTip: analyte specific and multiple analyte
performance verifiers
MicroWell: analyte specific and multiple analyte selling controls and
range verifiers | No change |
| Review Mode | Review Data by Assay and by Event
(scroll through multiple assays' QC
results which were run at the same time) | No change |
| Identification | Manual entry or Bar Code | No change |
| Frequency | According to the assay Instructions for
Use. User configurable QC expiration
interval. | No change |
| QC
Programming | Programmed by assay | No change |
8
9
10
| Differences | ||
|---|---|---|
| Device | ||
| Characteristic | Candidate | |
| VITROS XT 7600 System | Predicate Device | |
| VITROS 5600 | ||
| System | ||
| K081543 | ||
| The following | ||
| subsystems of | ||
| the VITROS | ||
| 5600 Integrated | ||
| System will be | ||
| modified | REFL – Reflectometer | |
| SLIN – Slide Incubator | ||
| SLSU – Slide Supply | ||
| SAIN – Sample Integrity | ||
| SRME – Sample and Reagent Metering | ||
| SWCT – System Control and Sample | ||
| Processing Software | ||
| SWIN – Software Infrastructure | ||
| SWUI – Graphical User Interface | ||
| Software | ||
| ADDI – Assay Data Disk. | All modifications | |
| pertain solely to the | ||
| MicroSlide | ||
| processing center. | ||
| There are no changes | ||
| being made to the | ||
| MicroTip and | ||
| MicroWell | ||
| processing centers. |
Method Comparison
Method Comparison testing was designed and conducted in accordance with CLSI EP09-A3, "Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline – Third Edition" (2013).
Method comparison studies were conducted by testing a minimum of 116 human serum samples with analyte concentrations across the analytical ranges of carbamazepine, creatinine and total bilirubin assays on the VITROS XT 7600 Integrated System and the VITROS 5600 Integrated System (predicate device). In addition, 125 human urine samples were tested for creatinine on the
11
candidate and predicate test systems. The results of the regression analyses for each of the assays are summarized below:
| VITROS
assay | N | Regression
Analysis | Slope | Intercept | Test range | Claimed
Measuring
Range |
|--------------------------|-----|------------------------|-------|-----------|------------|-------------------------------|
| CRBM
Serum
(ug/mL) | 118 | Deming | 1.00 | 0.12 | 3.1-17.8 | 3.0-20.0 |
| CREA
Serum
(mg/dL) | 116 | Passing
Bablock | 0.99 | 0.00 | 0.25-13.4 | 0.15-14.0 |
| CREA
Urine
(mg/dL) | 122 | Passing
Bablock | 0.99 | -0.45 | 3.7-331.0 | 3.2-346.5 |
| TBIL
Serum
(mg/dL) | 125 | Passing
Bablok | 0.99 | 0.01 | 0.14-23.65 | 0.10-27.00 |
In addition to the above mentioned method comparison studies, testing was performed to determine the precision, linearity, LoB, LoD, LoQ, and Interfering substances of the representative VITROS assays on the VITROS XT 7600 System.
Precision
Precision studies were conducted following EP05-A3. Evaluation of Quantitative Measurement Procedures, Approved Guidelines – Third Edition (2014). The study was performed by testing a minimum of two Quality control fluids and three human based precision fluids using the Carbamazepine (CRBM), Creatinine (CREA), and Total Bilirubin (TBIL) assays.
Samples were analyzed using one VITROS XT 7600 Integrated System over 20 days, with 2 runs per day and 2 replicates per specimen (n=80).
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| Fluid
ID | Mean
(ug/mL) | N | Repeatability
(Within Run) | | Within Day | | Between Day | | Between Cal | | Within Lab
(Total) | |
|-----------------|-----------------|----|-------------------------------|------|---------------|------|---------------|------|---------------|------|-----------------------|------|
| | | | SD
(ug/mL) | %CV | SD
(ug/mL) | %CV | SD
(ug/mL) | %CV | SD
(ug/mL) | %CV | SD
(ug/mL) | %CV |
| CRBM-
PP1 | 3.9 | 80 | 0.13 | 3.30 | 0.13 | 3.30 | 0.08 | 2.08 | 0.03 | 0.77 | 0.16 | 3.98 |
| CRBM-
6155-1 | 4.7 | 80 | 0.14 | 2.97 | 0.14 | 3.02 | 0.00 | 0.00 | 0.07 | 1.40 | 0.16 | 3.32 |
| CRBM-
6156-2 | 10.1 | 80 | 0.24 | 2.38 | 0.25 | 2.46 | 0.00 | 0.00 | 0.13 | 1.25 | 0.28 | 2.76 |
| CRBM-
PP3 | 11.6 | 80 | 0.30 | 2.57 | 0.35 | 2.98 | 0.00 | 0.00 | 0.18 | 1.56 | 0.39 | 3.37 |
| CRBM-
5896-3 | 13.1 | 80 | 0.29 | 2.19 | 0.35 | 2.67 | 0.00 | 0.00 | 0.22 | 1.64 | 0.41 | 3.14 |
| CRBM-
PP5 | 17.6 | 80 | 0.33 | 1.86 | 0.37 | 2.10 | 0.10 | 0.57 | 0.18 | 1.03 | 0.42 | 2.41 |
CRBM Precision Table (Conventional units)
CREA Serum Precision Table (Conventional units)
| | | | Repeatability
(Within Run) | | Within Day | | Between Day | | Between Cal | | Within Lab
(Total) | |
|------------------|-----------------|----|-------------------------------|-------|---------------|-------|---------------|-------|---------------|-------|-----------------------|-------|
| Fluid ID | Mean
(mg/dL) | N | SD
(mg/dL) | %CV | SD
(mg/dL) | %CV | SD
(mg/dL) | %CV | SD
(mg/dL) | %CV | SD
(mg/dL) | %CV |
| CREAS-
5903-1 | 0.82 | 80 | 0.006 | 0.713 | 0.009 | 1.050 | 0.003 | 0.364 | 0.009 | 1.121 | 0.013 | 1.579 |
| CREAS-
PP1 | 0.88 | 80 | 0.006 | 0.642 | 0.007 | 0.743 | 0.008 | 0.954 | 0.012 | 1.400 | 0.016 | 1.850 |
| CREAS-
SRM | 0.99 | 80 | 0.007 | 0.697 | 0.008 | 0.829 | 0.006 | 0.568 | 0.014 | 1.396 | 0.017 | 1.720 |
| CREAS-
5905-2 | 5.39 | 80 | 0.039 | 0.716 | 0.049 | 0.914 | 0.058 | 1.075 | 0.043 | 0.804 | 0.088 | 1.624 |
| CREAS-
PP2 | 9.63 | 80 | 0.057 | 0.594 | 0.070 | 0.729 | 0.049 | 0.513 | 0.104 | 1.079 | 0.135 | 1.400 |
| CREAS-
PP5 | 12.65 | 80 | 0.109 | 0.865 | 0.109 | 0.865 | 0.071 | 0.563 | 0.108 | 0.850 | 0.169 | 1.337 |
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| Fluid ID | Mean
(mg/dL) | N | Repeatability
(Within Run) | | Within Day | | Between Day | | Between Cal | | Within Lab
(Total) | |
|-------------------|-----------------|----|-------------------------------|------|---------------|------|---------------|------|---------------|------|-----------------------|------|
| | | | SD
(mg/dL) | %CV | SD
(mg/dL) | %CV | SD
(mg/dL) | %CV | SD
(mg/dL) | %CV | SD
(mg/dL) | %CV |
| CREAU-
66791-1 | 55.6 | 80 | 0.58 | 1.05 | 0.67 | 1.20 | 0.43 | 0.77 | 0.96 | 1.72 | 1.24 | 2.23 |
| CREAU-PP1 | 78.4 | 80 | 1.10 | 1.40 | 1.13 | 1.44 | 0.35 | 0.45 | 0.68 | 0.86 | 1.36 | 1.73 |
| CREAU-URN | 88.0 | 80 | 0.69 | 0.79 | 0.98 | 1.11 | 0.29 | 0.33 | 0.97 | 1.10 | 1.41 | 1.60 |
| CREAU-
66792-2 | 131.2 | 80 | 1.67 | 1.27 | 1.89 | 1.44 | 0.76 | 0.58 | 1.78 | 1.36 | 2.71 | 2.06 |
| CREAU-PP4 | 251.8 | 80 | 1.99 | 0.79 | 2.12 | 0.84 | 1.01 | 0.40 | 3.11 | 1.24 | 3.90 | 1.55 |
| CREAU-PP5 | 320.9 | 80 | 2.99 | 0.93 | 3.49 | 1.09 | 1.49 | 0.46 | 3.99 | 1.24 | 5.51 | 1.72 |
CREA Urine Precision Table (Conventional units)
TBIL Precision Table (Conventional units)
| | | | Repeatability
(Within Run) | | Within Day | | Between Day | | Between Cal | | Within Lab
(Total) | |
|-----------------|-----------------|----|-------------------------------|------|---------------|------|---------------|------|---------------|------|-----------------------|------|
| Fluid ID | Mean
(mg/dL) | N | SD
(mg/dL) | %CV | SD
(mg/dL) | %CV | SD
(mg/dL) | %CV | SD
(mg/dL) | %CV | SD
(mg/dL) | %CV |
| TBIL-PP1 | 0.3 | 80 | 0.01 | 4.54 | 0.02 | 5.20 | 0.01 | 4.25 | 0.00 | 0.00 | 0.02 | 6.72 |
| TBIL-5903-
1 | 1.6 | 80 | 0.03 | 1.68 | 0.04 | 2.88 | 0.01 | 0.51 | 0.03 | 1.84 | 0.05 | 3.45 |
| TBIL-PP3 | 6.5 | 80 | 0.03 | 0.52 | 0.06 | 0.87 | 0.06 | 0.88 | 0.04 | 0.64 | 0.09 | 1.40 |
| TBIL-5905-
2 | 15.3 | 80 | 0.10 | 0.67 | 0.16 | 1.05 | 0.10 | 0.68 | 0.15 | 0.99 | 0.24 | 1.60 |
| TBIL-PP5 | 21.6 | 80 | 0.17 | 0.77 | 0.20 | 0.92 | 0.28 | 1.29 | 0.00 | 0.00 | 0.34 | 1.58 |
Linearity
Linearity studies were performed according to CLSI EP06-A, Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approved Guideline (2003). VITROS CRBM Slides, VITROS CREA Slides, and VITROS TBIL Slides were tested on the VITROS XT 7600 Integrated System. A series of eleven proportionally related admixtures of low and high test fluids were tested to verify linearity; each sample was tested in triplicate, a minimum of two replicates was acceptable for analysis.
The linearity studies support the claimed measuring ranges for the VITROS CRBM, VITROS CREA, and VITROS TBIL assays.
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Detection Limits
Detection capability studies for each analyte were evaluated based upon CLSI EP17-A2, Evaluation of Detection Capability for Clinical Laboratory Measurements Procedures: Approved Guidelines – Second Edition (2012).
Limit of blank (LoB) studies were performed by testing 4 blank samples. Samples were tested in replicates of 6 over 3 days, using 3 lots of reagents, 4 samples every day, for a total of 216 observations (72 results per reagent lot). The LoB value for each assay was defined as the highest value achieved using blank samples with the stated probability (i.e. α = 5%). Since the data for all assays were non-gaussian, a non-parametric approach was applied that estimates the LoB using the calculated rank position corresponding to the 95th percentile of the distribution of blank values observed."
Limit of detection (LoD) studies were performed by testing 4 pools of human samples with analyte concentrations close to the expected detection limit for each analyte. Samples were tested in replicates of 6 over 3 days, using 3 lots of reagents, with the 4 human sample pools every day. for a total of 216 observations (72 results per reagent lot). The data were analyzed according to CLSI EP17-A2, using CLSI-approved statistical software Analyse-it version 4.95.4, Method Validation Edition (Analyse-it Software Limited, Leeds UK). The software calculated LoD using a pooled SD from the low level fluid results and the input LoB value for the assay, determined as described above. The LoD value for the assay is the highest resultant value achieved among the combinations of reagent lots and human pools evaluated, with the stated probability (i.e. ß= 5%).
Limit of Quantitation studies were performed using 4 pools of low level samples with analyte concentrations close to the expected LoQ of the corresponding assay. Samples were tested in replicates of 4 over 3 days, using 3 lots of reagents, 4 samples every day, for a total of 144 observations (48 results per reagent lot). Ortho defines LoQ as the lowest concentration with an imprecision of