(19 days)
No
The summary describes a standard in vitro diagnostic chemistry system and does not mention any AI or ML components.
No
The device is described as being "For in vitro diagnostic use only" and its function is to quantitatively measure albumin in serum and plasma, which is a diagnostic purpose, not a therapeutic one.
Yes
The 'Intended Use / Indications for Use' section explicitly states, "For in vitro diagnostic use only," referring to the VITROS Chemistry Products ALB Slides and VITROS Calibrator Kit 4 used for quantitative measurement of albumin in serum and plasma. The 'Device Description' further elaborates that the system uses these slides to "perform discrete chemistry tests on body fluid specimens" for "single quantitative measurement," which are characteristic functions of a diagnostic device.
No
The device description explicitly states it is comprised of "VITROS Chemistry Products range of chemistry products" (slides and calibrator kit) and "VITROS Chemistry System instrumentation," which are hardware components.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement in Intended Use: The "Intended Use / Indications for Use" section clearly states: "For in vitro diagnostic use only." This is a direct declaration of its intended purpose.
- Measurement of Analytes in Body Fluids: The device measures albumin (ALB) concentration in serum and plasma, which are body fluids. This is a core function of IVD devices.
- Use in a Laboratory Setting: The description mentions the "VITROS Chemistry System instrumentation," which is typically found in a laboratory or clinical setting where diagnostic tests are performed.
- Calibration with a Calibrator Kit: The use of a calibrator kit (VITROS Calibrator Kit 4) is standard practice for quantitative IVD tests to ensure accurate measurements.
The information provided strongly indicates that this device is designed and intended for use in performing diagnostic tests on samples taken from the human body, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
VITROS Chemistry Products ALB Slides For in vitro diagnostic use only. VITROS ALB Slides quantitatively measure albumin (AL concentration in serum and plasma.
VITROS Calibrator Kit 4 For in vitro diagnostic use only. VITROS Calibrator Kit 4 is intended for use in calibration of the VITROS Chemistry Systems for the quantitative measurement of ALB, BuBc, Fe, TBIL, TIBC, and TP.
Product codes (comma separated list FDA assigned to the subject device)
CIX, JIX
Device Description
The VITROS Chemistry System uses Vitros Slides to perform discrete chemistry tests on body fluid specimens. All reactions necessary for a single quantitative measurement take place within the multi-layered analytical element of a Vitros Slide.
The system is comprised of two main elements:
- The VITROS Chemistry Products range of chemistry products (in this case VITROS Chemistry Products ALB Slides, VITROS Chemistry Products Calibrator Kit 4, which are combined by the VITROS Chemistry System to perform the VITROS ALB test.
- The VITROS Chemistry System instrumentation, which provides automated use of the chemistry slides. Multiple VITROS Chemistry Systems were cleared for market by separate 510(k) pre-market notifications (K890928, K890929, K922072, K946090 and K922072).
The VITROS Chemistry System and Calibrators are dedicated specifically for use only with the VITROS Chemistry Products range of products.
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)
Equivalence was demonstrated using manufactured slides along with patient and quality control samples with measured albumin values spanning the assay range.
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.
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.
K890928, K890929, K922072, K946090, K922072
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
Summary Information
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: KOQ 3875
-
- Submitter Ortho-Clinical Diagnostics, Inc. name, 100 Indigo Creek Drive address, Rochester, New York 14626-5101 contact (585) 453-4041
Contact Person: Marlene A. Hanna
- Submitter Ortho-Clinical Diagnostics, Inc. name, 100 Indigo Creek Drive address, Rochester, New York 14626-5101 contact (585) 453-4041
-
Date Special 510(k) prepared: November 20, 2002 2. Preparation date
-
- Device Trade or Proprietary Name: name VITROS Chemistry Products ALB Slides VITROS Chemistry Products Calibrator Kit 4 Common Name Classification Name: Albumin test system ( 21 CFR 862.1035).
-
- Predicate The VITROS Chemistry Products ALB Slides (modified) and VITROS device Chemistry Products Calibrator Kit 4 are substantially equivalent to the VITROS Chemistry Products ALB Slides (current slide) and VITROS Chemistry Products Calibrator Kit 4.
Continued on next page
1
510(k) Summary, Continued
The VITROS Chemistry System uses Vitros Slides to perform discrete 5. Device chemistry tests on body fluid specimens. All reactions necessary for a single description quantitative measurement take place within the multi-layered analytical element of a Vitros Slide.
The system is comprised of two main elements:
-
- The VITROS Chemistry Products range of chemistry products (in this case VITROS Chemistry Products ALB Slides, VITROS Chemistry Products Calibrator Kit 4, which are combined by the VITROS Chemistry System to perform the VITROS ALB test.
The VITROS Chemistry System and Calibrators are dedicated specifically for use only with the VITROS Chemistry Products range of products.
-
- Device VITROS ALB Slides intended For in vitro diagnostic use only. use VITROS ALB Slides quantitatively measure albumin (ALB) concentration in serum and plasma.
VITROS Calibrator Kit 4 For in vitro diagnostic use only. VITROS Calibrator Kit 4 is intended for use in calibration of the VITROS Chemistry Systems for the quantitative measurement of ALB, BuBc, Fe, TBIL, TIBC, and TP.
- Device VITROS ALB Slides intended For in vitro diagnostic use only. use VITROS ALB Slides quantitatively measure albumin (ALB) concentration in serum and plasma.
Continued on next page
2
510(k) Summary, Continued
The VITROS Chemistry Products ALB Slide (modified) and VITROS 7. Comparison to predicate Chemistry Products Calibrator Kit 4 are substantially equivalent to VITROS Chemistry Products ALB Slide and VITROS Chemistry Products Calibrator device Kit 4 which were cleared by the FDA for in vitro diagnostic use. ALB Slide: (K812030, Cleared August 3, 1981) Calibrator Kit 4: (K922072, July 19, 1992).
Table 1 lists the characteristics of the tests performed using the VITROS ALB Slide (modified) and the VITROS ALB Slide (current).
Table 1 List of Slide Characteristics: Comparison to Predicate Device
| Device
Characteristic | New Device
VITROS ALB Slide | Predicate Device
VITROS ALB Slide |
|----------------------------------------------------------------------|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| | (Modified) | (Current) |
| Sample volume | 5.5 µL | 10 µL |
| Quantity of
Reactive
Ingredients per
slide (test) | Bromcresol green dye: 125.4 µg | Bromcresol green dye: 250 µg |
| Concentrations of
Slide Reactive
Ingredients per
cm-squared | No Change. | Bromcresol green: 139.4 µg /cm² |
| Intended Use | No change. | For in vitro diagnostic use only.
VITROS ALB Slides quantitatively measure
albumin concentration in serum and plasma. |
| Basic principle | No Change. | Dry, multilayered slide utilizing reflectance
spectrophotometry |
| Sample type | No Change. | Serum , plasma |
| Reportable Range
Serum, Plasma | No Change. | 1.0 - 6.00 g/ dL (Conv. Units)
10.0 - 60.0 g/L (SI Units)
152 - 912 µmol/L (Alternate Units) |
| Instrumentation | No Change. | VITROS 250, 500, 750 and 950 Series Analyzers |
| Incubation time
and temperature | No Change. | Approximately ,5 minutes at 37°C |
Continued on next page
3
510(k) Summary, Continued
The information presented in the pre-market notification demonstrates that the 8. Conclusions performance of the VITROS ALB Slides (modified) for use with human serum and plasma is substantially equivalent to the cleared predicate device.
Equivalence was demonstrated using manufactured slides along with patient and quality control samples with measured albumin values spanning the assay range.
The information presented in the premarket notification provides a reasonable assurance that the VITROS ALB Slides (modified) for use with human serum and plasma is safe and effective for the stated intended use.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the caduceus symbol.
Food and Drug Administratio 2098 Gaither Road Rockville MD 20850
DEC 1 0 2002
Ms. Marlene A. Hanna Regulatory Affairs Associate Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101
Re: . K023875
Trade/Device Name: VITROS Chemistry Products ALB Slides/ VITROS Chemistry Products Calibrator Kit 4
Regulation Number: 21 CFR § 862.1035 Regulation Name: Albumin test system Regulatory Class: II Product Code: CIX: JIX Dated: November 20, 2002 Received: November 21, 2002
Dear Ms. 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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
5
Page 2
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
Statement of Intended Use
Page 1 of 1
510(k) Number (if known):
Summary and Explanation of
Test:
Device Name:
Intended Use:
VITROS Chemistry Products ALB Slides VITROS Chemistry Products Calibrator Kit 4
VITROS Chemistry Products ALB Slides For in vitro diagnostic use only. VITROS ALB Slides quantitatively measure albumin (AL concentration in serum and plasma.
VITROS Calibrator Kit 4 For in vitro diagnostic use only. VITROS Calibrator Kit 4 is intended for use in calibration of the VITROS Chemistry Systems for the quantitative measurement of ALB, BuBc, Fe, TBIL, TIBC, and TP.
Of all serum proteins, albumin is present in the highest concentration. It maintains the plasma oncotic pressure and the transport of many substances. Increased serum albumin may indicate dehydration or hyperinfusion with albumin; a decrease is found in rapid hydration, overhydration, severe malnutrition and malabsorbtion, severe diffuse liver necrosis, chronic active hepatitis, and neoplasia. Albumin is commonly reduced in chronic alcoholism, pregnancy, renal protein loss, thyroid dysfunction, peptic ulcer disease, and chronic inflammatory disease. '
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Carol C Benson for B Jean Cooper
(Division Sign-Off)
Division: Common Laboratory Devices
| 510(k) Number: | K023875 |
|---|---|
| ---------------- | --------- |
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| ------------------------------------------ | ---- | ---------------------- |
(Optional Format 1-2-96)