K Number
K191316
Device Name
VITROS XT Chemistry Products ALB-TP Slides
Date Cleared
2019-06-07

(23 days)

Product Code
Regulation Number
862.1035
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Rx Only For in vitro diagnostic use only The ALB test within the VITROS XT Chemistry Products ALB-TP Slides quantitatively measures albumin (ALB) concentration in serum and plasma using the VITROS XT 7600 Integrated System. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.
Device Description
The new device, the VITROS XT Chemistry Products ALB-TP Slides is a single device that contains both an albumin test and a total protein test side by side separated by a plastic barrier sealed within a single slide frame. In this format, individual reactions occur and test results are generated for each analyte independently of the other analyte. The ALB test is a multilayered, analytical element coated on a polyester support. For the albumin measurement, a drop of patient sample is deposited on the slide and is evenly distributed by the spreading layer to the underlying layers. When the fluid penetrates the reagent layer, the bromcresol green (BCG) dye diffuses to the spreading layer and binds to albumin in the sample. This binding results in a shift in wavelength of the reflectance maximum of the free dye. The color complex that forms is measured by reflectance spectrophotometry. The amount of albumin-bound dye is proportional to the concentration of albumin in the sample.
More Information

Not Found

No
The device description and performance studies focus on traditional chemical reaction and spectrophotometry methods, with no mention of AI or ML.

No
The device is described as being "For in vitro diagnostic use only" to quantitatively measure albumin concentration in serum and plasma, which is used in the diagnosis and treatment of diseases but does not actively treat them.

Yes

The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use only" and "Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys."

No

The device description clearly states it is a "multilayered, analytical element coated on a polyester support" and describes a chemical reaction involving a dye and reflectance spectrophotometry, indicating it is a physical in vitro diagnostic device, not software only.

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Explicit Statement: The document explicitly states "For in vitro diagnostic use only" in the "Intended Use / Indications for Use" section.
  • Intended Use: The intended use is to "quantitatively measure albumin (ALB) concentration in serum and plasma," which are biological samples taken from the body.
  • Purpose: The measurements are used "in the diagnosis and treatment of numerous diseases," which is a key characteristic of IVD devices.
  • Mechanism: The device uses a chemical reaction (binding of bromcresol green dye to albumin) to analyze the sample outside of the body.

All of these points align with the definition of an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

For in vitro diagnostic use only

The ALB test within the VITROS XT Chemistry Products ALB-TP Slides quantitatively measures albumin (ALB) concentration in serum and plasma using the VITROS XT 7600 Integrated System. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

Product codes (comma separated list FDA assigned to the subject device)

CIX

Device Description

The new device, the VITROS XT Chemistry Products ALB-TP Slides is a single device that contains both an albumin test and a total protein test side by side separated by a plastic barrier sealed within a single slide frame. In this format, individual reactions occur and test results are generated for each analyte independently of the other analyte.

The ALB test is a multilayered, analytical element coated on a polyester support.

For the albumin measurement, a drop of patient sample is deposited on the slide and is evenly distributed by the spreading layer to the underlying layers. When the fluid penetrates the reagent layer, the bromcresol green (BCG) dye diffuses to the spreading layer and binds to albumin in the sample. This binding results in a shift in wavelength of the reflectance maximum of the free dye. The color complex that forms is measured by reflectance spectrophotometry. The amount of albumin-bound dye is proportional to the concentration of albumin in the sample.

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: Serum samples (127) were evaluated on the VITROS XT Chemistry Products ALB-TP Slides using the VITROS XT 7600 Integrated System and on VITROS Chemistry Products ALB Slides using the VITROS 5600 Integrated System. Correlation coefficient was 0.999.
Matrix comparison: Serum and plasma samples (Na-heparin, Li-heparin, and PST) were evaluated. All collection devices were compared to the red top plastic serum tube. Demonstrated equivalence.
Precision: Evaluated with patient pools and quality control materials following CLSI Protocol EP05-A3. Included 80 observations (2 replicates per run, 2 runs per day over 20 days) using three lots of VITROS XT ALB-TP Slides. Coefficients of variation ranged from 0.7% to 1.4% for Within Lab precision.
Detection Limits: Evaluated according to CLSI EP17-A2. LOB was 0.24 g/dL, LOD was 0.27 g/dL, LOQ was 0.60 g/dL. Claimed LOQ is 1.0 g/dL.
Linearity: Performed according to CLSI EP06-A. A series of seventeen proportionally related admixtures of low and high test fluids were tested in quadruplicate. Linear range was 0.5 - 7.1 g/dL, supporting the claimed measuring range of 1.0 - 6.0 g/dL. Least squares regression: y = 1.01x - 0.19 with R = 1.00.
Specificity: Screened for interfering substances following CLSI document EP07-A3. Dextran 40 and Hemoglobin were found to interfere at certain concentrations. Forty-seven test substances were found not to interfere.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

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.

K023875

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

§ 862.1035 Albumin test system.

(a)
Identification. An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.(b)
Classification. Class II.

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and 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.

June 7, 2019

Ortho-Clinical Diagnostics, Inc. Darlene Phillips Manager, Regulatory Affairs 100 Indigo Creek Drive Rochester, NY 14626

Re: K191316

Trade/Device Name: VITROS XT Chemistry Products ALB-TP Slides Regulation Number: 21 CFR 862.1035 Regulation Name: Albumin test system Regulatory Class: Class II Product Code: CIX Dated: May 14, 2019 Received: May 15, 2019

Dear Darlene Phillips:

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 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, Ph.D. Acting Director Division of Chemistry and Toxicology 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) K191316

Device Name VITROS XT Chemistry Products ALB-TP Slides

Indications for Use (Describe) Rx Only

For in vitro diagnostic use only

The ALB test within the VITROS XT Chemistry Products ALB-TP Slides quantitatively measures albumin (ALB) concentration in serum and plasma using the VITROS XT 7600 Integrated System. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

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

510(k) Summary

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: K191316

Submitter's Information

Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101 Phone: (585) 453-4253 Fax: (585) 453-3113

Contact Person:

Darlene J Phillips, RAC Manager, Regulatory Affairs

Date of Preparation: May 14, 2019 Revised:

Device Proprietary Name(s):

VITROS XT Chemistry Products ALB-TP Slides

Common Names:

Albumin assay

Classification Names

| Test | Product
Code | Class | Regulation Section | Panel |
|------|-----------------|----------|-------------------------------------|-------------------------------|
| ALB | CIX | Class II | 21 CFR 862.1035 Albumin test system | Clinical
Chemistry
(75) |

Predicate Device(s)

Predicate DevicesFDA 510(k) Number
VITROS Chemistry Products ALB SlidesK023875

4

Intended Use Statement(s) VITROS XT Chemistry Products ALB-TP Slides

Rx Only For in vitro diagnostic use only

The ALB test within the VITROS XT Chemistry Products ALB-TP Slides quantitatively measures albumin (ALB) concentration in serum and plasma using the VITROS XT 7600 Integrated System. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

Device Description

The new device, the VITROS XT Chemistry Products ALB-TP Slides is a single device that contains both an albumin test and a total protein test side by side separated by a plastic barrier sealed within a single slide frame. In this format, individual reactions occur and test results are generated for each analyte independently of the other analyte.

The ALB test is a multilayered, analytical element coated on a polyester support.

For the albumin measurement, a drop of patient sample is deposited on the slide and is evenly distributed by the spreading layer to the underlying layers. When the fluid penetrates the reagent layer, the bromcresol green (BCG) dye diffuses to the spreading layer and binds to albumin in the sample. This binding results in a shift in wavelength of the reflectance maximum of the free dye. The color complex that forms is measured by reflectance spectrophotometry. The amount of albumin-bound dye is proportional to the concentration of albumin in the sample.

Comparison to Predicate Devices

The following tables show similarities and differences between the new and predicate devices.

| Summary of the technological characteristics of the device compared to the predicate

device
Device
CharacteristicNew Device
VITROS XT ALB-TP Slide
[K191316]
(New)Predícate Device
VITROS ALB Slide [K023875]
(Current)
Intended UseNo change
For in vitro diagnostic use only.
The ALB test within the VITROS
XT ALB-TP Chemistry Products
Slides measures albumin (ALB)
concentration in serum and
plasma.For in vitro diagnostic use only.
VITROS Chemistry Products ALB
Slides quantitatively measure
albumin (ALB) concentration in
serum and plasma.
Device
DescriptionNo ChangeMultilayered, analytical element
coated on a polyester support
Basic PrincipleNo ChangeColorimetric

5

| Summary of the technological characteristics of the device compared to the predicate

device
Device
CharacteristicNew Device
VITROS XT ALB-TP Slide
[K191316]
(New)Predicate Device
VITROS ALB Slide [K023875]
(Current)
Incubation time
and temperatureNo ChangeApproximately 2.5 minutes
37°C (98.6° F)
Sample typeNo ChangeSerum and plasma
Amount of Slide
Reactive
Ingredients per
cm² (test)The composition of the analytical
element of each test within the
VITROS XT Slide will remain
the same as that used in each
predicate deviceBromcresol green dye 104 µg.
Assay RangeNo Change1.0 - 6.0 g/dL
CalibratorsNo ChangeVITROS Chemistry Products
Calibrator Kit 4
ControlsNo ChangeVITROS Chemistry Products
Performance Verifier I and II
Differences
InstrumentationVITROS XT 7600 Integrated
SystemVITROS 250/350, 5,1 FS and 4600
Chemistry Systems
VITROS 5600 and XT 7600
Integrated Systems
Sample volume4.2 µL5.5 µL

Non-Clinical Testing Analytical Performance

Method Comparison

Method Comparison testing followed CLSI Protocol EP09-A3, Measurement Procedure Comparison and Bias Estimation Using Patient Samples. Serum samples were evaluated on the VITROS XT Chemistry Products ALB-TP Slides using the VITROS XT 7600 Integrated System and on VITROS Chemistry Products ALB Slides using the VITROS 5600 Integrated System. The correlation between the predicate and the ALB test within the VITROS XT ALB-TP Slides on the VITROS XT 7600 Integrated System is summarized below.

Ordinary Deming regression was performed to determine the correlation for the ALB test within the VITROS XT ALB-TP Slides.

Summary of Method Comparison Regression Analysis Data
TestNSlopeInterceptCorr. Coeff.Test RangeMeasuring range
ALB (g/dL)1271.00-0.030.9991.0 - 5.91.0 - 6.0

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Matrix comparison:

To demonstrate equivalence between serum and plasma samples, serum (glass red top, plastic red top and SST) and plasma (Na-heparin, Li-heparin, and PST) specimen collection tubes were evaluated to verify acceptable performance.

All collection devices were compared to the red top plastic serum tube using Weighted Deming regression. The regression assessments use the mean of the red top plastic serum tube (two replicates) versus the replicates of the feature tube (two replicates).

Sample TypeSlopeIntercept
Na Hep vs. Serum Plastic0.960.098
Li Hep vs. Serum Plastic0.960.088
PST vs. Serum Plastic0.950.107
SST vs. Serum Plastic0.990.033
Serum Glass vs. Serum Plastic1.00- 0.007

Precision

Precision was evaluated with patient pools and quality control materials following CLSI Protocol EP05-A3, Evaluation of Precision Performance of Quantitative Methods; Approved Guideline-Third Edition, using the VITROS XT Chemistry Products ALB-TP Slides on the VITROS XT 7600 Integrated System. The test included 80 observations (2 replicates per run, 2 runs per day over 20 days) using three lots of VITROS XT ALB-TP Slides. The ALB test long term precision analysis for a representative lot is summarized below.

The data presented are a representation of test performance and are provided as a guideline. Variables such as sample handling and storage, reagent handling and storage, laboratory environment, and system maintenance can affect reproducibility of test results.

Conventional Units (g/dL Albumin)
Mean
ConcentrationRepeatability
SD*%CVWithin Day
SD**%CVWithin Lab
SD***%CVNo. of
Obs.No. of
Days
1.60.021.20.021.20.021.48020
2.70.020.90.020.90.031.28020
3.40.030.80.030.90.041.18020
4.10.041.00.041.00.051.38020
4.40.030.70.030.80.040.98020
5.20.050.90.051.10.061.28020

*Repeatability (formerly called within-run precision) was determined using two replicates per run.

** Within Day precision was determined using two runs per day with two replicates per run

***Within Lab precision was determined using a single lot of slides and a single calibration

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Detection Limits

Detection capability studies for the ALB test within the VITROS XT ALB-TP Slides were evaluated according to CLSI EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures.

LoQ determination was set on pre-defined Total Error (TE) goals based on the Westgard model. The Total Error goal used to accept the LoQ was ≤ 0.2 g/dL.

The results of this analysis are summarized below:

ALB (g/dL)
LOB0.24
LOD0.27
LOQ0.60
Claimed LOQ1.0

Linearity

Linearity studies were performed according to CLSI EP06-A, Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approved Guideline (2003). VITROS XT ALB-TP Slides were tested on the VITROS XT 7600 Integrated System. A series of seventeen proportionally related admixtures of low and high test fluids were tested to verify linearity of the ALB test; each sample was tested in quadruplicate. The linearity study supports the claimed measuring range for the ALB test within the VITROS XT ALB-TP Slides.

AssayMeasuring RangeLinear Range
ALB1.0 - 6.0 g/dL0.5 - 7.1 g/dL

A least squares regression was performed on the data collected, y = 1.01x-0.19 with R = 1.00.

Serum and plasma samples with values greater than the ALB test measuring range may be diluted with 10 parts sample and 1 part diluent. Reagent-grade water and isotonic saline are acceptable diluents for the ALB test within the VITROS XT Chemistry Products ALB-TP Slides.

Expected Values

The expected values of the ALB test within the VITROS XT ALB-TP Slides are not changed from that of the predicate assay. Each laboratory should confirm the validity of these intervals for the population it serves.

ALB Reference Interval "

ALB Test Expected Values
3.5–5.0 g/dL

Each laboratory should confirm the validity of these intervals for the population it serves.

4 Peters T. All about Albumin San Diego: Academic Press; 256; 1996.

Specificity

The ALB test within the VITROS XT Chemistry Products ALB-TP Slide was screened for interfering substances following CLSI document EP07-A3, Interference Testing in Clinical

Ortho-Clinical Diagnostics, Inc.

8

Chemistry. The supplemental tables in CLSI document EP37 were referenced for recommended testing concentrations for analytes and endogenous substances that may interfere in clinical chemistry measurement procedures.

Point estimates of the effects of potential interferents on the ALB test within the VITROS XT ALB-TP Slides were made using the paired difference method. Dose-response analysis was conducted to characterize the degree of interference for each substance that exceeded the acceptance criterion in the initial screening test, and expected bias was reported at the lowest test level which did not meet acceptance criteria for bias as shown in the product claims.

Two (2) substances were found to interfere with the ALB test in VITROS XT Chemistry Products ALB-TP Slides. The substances listed in the table, when tested at the concentrations indicated, caused the bias shown. The bias is an estimate of the maximum bias observed.

It is possible that other interfering substances may be encountered. These results are representative; however, your results may differ somewhat due to test-to-test variation. The degree of interference at concentrations other than those listed might not be predictable.

Known Interferences ALB test
InterferentInterferent
Concentration
(Conv. Units)Albumin
Concentration
(g/dL)Bias*
(g/dL)
Dextran 406 g/dL3.8-0.38
Dextran 404 g/dL4.8-0.58
Hemoglobin300 mg/dL3.80.32
Hemoglobin200 mg/dL4.60.37

采 The bias is an estimate of the maximum bias observed

Forty-seven (47) test substances, when tested at the concentrations indicated, were found not to interfere with the ALB test within VITROS XT ALB-TP Slides, bias