(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 an in vitro diagnostic (IVD) product used to measure magnesium levels, which provides diagnostic information rather than directly treating a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the VITROS Chemistry Products Mg Slides "quantitatively measure magnesium (Mg) concentration in serum, plasma, and urine," and the "VITROS Calibrator Kit 1 is intended for use in calibration of the VITROS Chemistry Systems for the quantitative measurement of BUN/ UREA, Ca, CREA, GLU, LAC, Li, Mg, PHOS, SALI, THEO, and URIC." These are measurements used for diagnostic purposes.
No
The device description explicitly states it is comprised of "The VITROS Chemistry Products range of chemistry products" (slides and calibrator kit) and "The VITROS Chemistry System - instrumentation," indicating it includes hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For in vitro diagnostic use only." This is the most direct indicator.
- Nature of the Test: The device measures magnesium concentration in biological samples (serum, plasma, and urine). This is a common type of in vitro diagnostic test performed on body fluids outside of the body.
- Components: The description mentions "VITROS Chemistry Products Mg Slides" and "VITROS Calibrator Kit 1," which are reagents and calibrators used in laboratory testing. These are typical components of IVD systems.
- System Description: The "Device Description" explains that the system uses these products to perform "discrete chemistry tests on body fluid specimens," which is the definition of in vitro diagnostic testing.
- Predicate Devices: The listed predicate devices (K861386 VITROS Chemistry Products Mg Slide and K001885 VITROS Chemistry Products Calibrator Kit 1) are also IVD products, indicating that this device falls within the same regulatory category.
Therefore, based on the provided information, this device is definitively an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
VITROS Chemistry Products Mg Slides
For in vitro diagnostic use only.
VITROS Mg Slides quantitatively measure magnesium (Mg) concentration in serum, plasma, and urine.
VITROS Calibrator Kit 1
For in vitro diagnostic use only.
VITROS Calibrator Kit 1 is intended for use in calibration of the
VITROS Chemistry Systems for the quantitative measurement of
BUN/ UREA, Ca, CREA, GLU, LAC, Li, Mg, PHOS, SALI, THEO, and URIC.
Product codes (comma separated list FDA assigned to the subject device)
JIX; JGJ
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: 1. The VITROS Chemistry Products range of chemistry products (in this case VITROS Chemistry Products Mg Slides, VITROS Chemistry Products Calibrator Kit 1, which are combined by the VITROS Chemistry System to perform the VITROS Mg test. 2. 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 Magnesium 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
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
DEC 1 0 2002
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: KC23876
-
Ortho-Clinical Diagnostics, Inc. 1. Submitter 100 Indigo Creek Drive name, Rochester, New York 14626-5101 address, contact (585) 453-4041
Contact Person: Marlene A. Hanna -
Date Special 510(k) prepared: November 20, 2002 2. Preparatio n date
-
Trade or Proprietary Name: 3. Device VITROS Chemistry Products Mg Slides name VITROS Chemistry Products Calibrator Kit 1 Common Name Classification Name: Magnesium test system ( 21 CFR 862.1495).
-
The VITROS Chemistry Products Mg Slides (modified) and VITROS 4. Predicate device Chemistry Products Calibrator Kit 1 are substantially equivalent to the VITROS Chemistry Products Mg Slides (current slide) and VITROS Chemistry Products Calibrator Kit 1.
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: 1. The VITROS Chemistry Products range of chemistry products (in this case VITROS Chemistry Products Mg Slides, VITROS Chemistry Products Calibrator Kit 1, which are combined by the VITROS Chemistry System to perform the VITROS Mg test. 2. 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. 6. Device VITROS Mg Slides intended For in vitro diagnostic use only. VITROS Mg Slides quantitatively measure Magnesium (MG) concentration use in serum, plasma, and urine. VITROS Calibrator Kit 1 For in vitro diagnostic use only. VITROS Calibrator Kit 1 is intended for use in calibration of the VITROS Chemistry Systems for the quantitative measurement of BUN/UREA. Ca. CREA, GLU, LAC, Li, Mg, PHOS, SALI, THEO, and URIC. Continued on next page
2
- The VITROS Chemistry Products Mg Slide (modified) and VITROS 7. Comparison Chemistry Products Calibrator Kit 1 are substantially equivalent to VITROS to Chemistry Products Mg Slide and VITROS Chemistry Products Calibrator Kit predicate 1 that were cleared by the FDA for in vitro diagnostic use. device Mg Slide: (K861386, Cleared August 26, 1986) Calibrator Kit 1: (K001885 Cleared July 20, 2000)
Table 1 lists the characteristics of the tests performed using the VITROS Mg Slide (modified) and the VITROS Mg Slide (current).
| Device
Characteristic | New Device
VITROS Mg Slide
(Modified) | Predicate Device
VITROS Mg Slide
(Current) |
|-------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sample volume | 5 µL | 10 µL |
| Quantity of
Reactive
Ingredients per
slide (test) | 1,2-bis(o-aminophenoxy)ethane-N,N,N',N'-
tetraacetic acid (calcium chelator) 272.1 µg
and
1,5-bis(2-hydroxy-3,5-dichlorophenyl)-3-
cyanoformazan (dye) 46.19 µg | 1,2-bis(o-aminophenoxy)ethane-N,N,N',N'-
tetraacetic acid (calcium chelator) 542.3 µg and
1,5-bis(2-hydroxy-3,5-dichlorophenyl)-3-
cyanoformazan (dye) 92.06 µg |
| Concentrations
of Slide
Reactive
Ingredients per
cm-squared | No Change. | 1,2-bis(o-aminophenoxy)ethane-N,N,N',N'-
tetraacetic acid (calcium chelator) 302.3 µg and
1,5-bis(2-hydroxy-3,5-dichlorophenyl)-3-
cyanoformazan (dye) 51.32 µg |
| Intended Use | No change. | For in vitro diagnostic use only.
VITROS Mg Slides quantitatively measure
magnesium (Mg) concentration in serum,
plasma and urine. |
| Basic principle | No Change. | Dry, multilayered slide utilizing reflectance
spectrophotometry |
| Sample type | No Change. | Serum , plasma , urine |
| Reportable
Range | | |
| Serum,Plasma: | No Change. | 0.20 - 10.00 mg/ dL |
| Urine: | No Change. | 1.20 - 60.00 mg/dL (after multiplying by a 6X
dilution factor) |
| Instrumentation | No Change. | VITROS 250, 500, 750 and 950 Series
Analyzers |
| Incubation time
and temperature | No Change. | Approximately 5 minutes at 37°C |
Table 1 List of Slide Characteristics: Comparison to Predicate Device
Continued on next page
3
510(k) Summary, Continued
The information presented in the pre-market notification demonstrates that 8. Conclusions the performance of the VITROS Mg Slides (modified) for use with human serum, plasma, and urine is substantially equivalent to the cleared predicate device.
Equivalence was demonstrated using manufactured slides along with patient and quality control samples with measured Magnesium values spanning the assay range.
The information presented in the premarket notification provides a reasonable assurance that the VITROS Mg Slides (modified) for use with human serum, plasma, and urine 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 & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines.
Food and Drug Administration 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
K023876 Re:
Trade/Device Name: VITROS Chemistry Products Mg Slides/ VITROS Chemistry Products Calibrator Kit 1
Regulation Number: 21 CFR § 862.1150 Regulation Name: Calibrator Regulatory Class: II Product Code: JIX; JGJ 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 (OS) 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. 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): | K023876 |
| Device Name: | VITROS Chemistry Products Mg Slides |
| VITROS Chemistry Products Calibrator Kit 1 | |
| Intended Use: | VITROS Chemistry Products Mg Slides |
| For in vitro diagnostic use only. | |
| VITROS Mg Slides quantitatively measure magnesium (Mg) concentration in serum, plasma, and urine. | |
| VITROS Calibrator Kit 1 | |
| For in vitro diagnostic use only. | |
| VITROS Calibrator Kit 1 is intended for use in calibration of the | |
| VITROS Chemistry Systems for the quantitative measurement of | |
| BUN/ UREA, Ca, CREA, GLU, LAC, Li, Mg, PHOS, SALI, THEO, and URIC. | |
| Summary and Explanation of Test: | Magnesium is predominantly an intracellular cation and is essential in enzyme reactions. Magnesium deficiency may cause weakness, tremors, tetany, and convulsions. Hypomagnesemia is associated with hypocalcemia, alcoholism, some types of malnutrition, chronic hemodialysis, and pregnancy. Increased serum magnesium concentrations occur in patients with renal failure, dehydration, and Addison's disease. 1 |
(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 Jean Cooper | |
|---|---|
| (Division Sign-Off) | |
| Division | Clinical Laboratory Devices |
| 510(k) Number | K023876 |
| Prescription Use | X | OR | Over-The-Counter Use |
|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |