(21 days)
Not Found
No
The description details a standard spectrophotometric chemical assay and does not mention any AI or ML components in the device or its operation.
No.
This device is an in vitro diagnostic (IVD) device used to measure calcium levels in patient samples, which aids in the diagnosis and treatment of various medical conditions, but it does not directly treat or prevent a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use only" and further explains that "Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone disorders, chronic renal disease and tetany". This clearly indicates its role in diagnosing medical conditions.
No
The device description clearly details physical components like "multilayered, analytical element coated on a polyester support," "reagent layer," and "lyophilized standards." It also describes a process involving chemical reactions and spectrophotometric measurement, which requires hardware.
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."
- Measurement of Analytes in Biological Samples: The device measures calcium concentration in serum, plasma, and urine, which are biological samples.
- Diagnostic Purpose: The intended use states that calcium measurements are used in the diagnosis and treatment of various diseases and conditions.
- In Vitro Process: The "Device Description" details how the assay is performed using a slide and reagents, with reactions taking place within the multi-layered analytical element, outside of the living organism.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
VITROS Chemistry Products Ca Slides
For in vitro diagnostic use only. VITROS Ca Slides quantitatively measure calcium (Ca) concentration in serum, plasma, and urine. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone disorders, chronic renal disease and tetany (intermittent muscular contractions or spasms).
VITROS Chemistry Products Calibrator Kit 1
For in vitro diagnostic use only. VITROS Calibrator Kit 1 is used to calibrate 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)
CJY, JIX
Device Description
The VITROS Chemistry Products Ca Slide assay is performed using the VITROS Chemistry Products Ca Slide and the VITROS Chemistry Products Calibrator Kit 1 on the VITROS Chemistry Systems. The VITROS Ca Slide is a multilayered, analytical element coated on a polyester support. All reactions necessary for a single quantitative measurement of calcium take place within the multi-layered analytical element of a VITROS Chemistry Products Ca slide.
A drop of patient sample is deposited on the VITROS Ca Slide and is evenly distributed by the spreading layer to the underlying layers. The bound calcium is dissociated from binding proteins, allowing the calcium to penetrate through the spreading layer into the underlying reagent layer. In the reagent layer, the calcium forms a complex with Arsenazo III dye, causing a shift in the absorption maximum.
After incubation, the reflection density of the colored complex is measured spectrophotometrically by a VITROS Chemistry System. The amount of colored complex formed is proportional to the calcium concentration in the sample fluid. The test result is reported in milligrams per deciliter (mg/dL) or millimoles per liter (mmol/ L).
VITROS Chemistry Products Calibrator Kit 1 contains three levels of lyophilized standards with corresponding diluents. The standards are prepared from processed bovine serum to which organic analytes, electrolytes, stabilizers, and preservatives have been added. The companion diluents are prepared from processed water to which inorganic salts have been added.
The VITROS Chemistry System and reagents are designed specifically for use 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 calcium 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.
Not Found
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.
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
§ 862.1145 Calcium test system.
(a)
Identification. A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).(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: K072440
-
- Submitter Ortho-Clinical Diagnostics, Inc. name. 100 Indigo Creek Drive Rochester, New York 14626-5101 address, contact (585) 453-4041
Contact Person: Marlene A. Hanna
- Submitter Ortho-Clinical Diagnostics, Inc. name. 100 Indigo Creek Drive Rochester, New York 14626-5101 address, contact (585) 453-4041
-
- Preparation Date Special 510(k) prepared: August 29, 2007 date
-
- Device Trade or Proprietary Name: name VITROS Chemistry Products Ca Slides Common Name: calcium test Classification Name: Calcium test system (21 CFR 862.1145)
VITROS Chemistry Products Calibrator Kit I Common Name: calibrator Classification Name: Calibrator (21 CFR 862.1150)
- The VITROS Chemistry Products Ca Slides (modified) and VITROS Chemistry 4. Predicate device Products Calibrator Kit 1 are substantially equivalent to the VITROS Chemistry Products Ca Slides (current slide) and VITROS Chemistry Products Calibrator Y it 1.
Continued on next page
1
510(k) Summary, Continued
The VITROS Chemistry Products Ca Slide assay is performed using the VITROS 5. Device Chemistry Products Ca Slide and the VITROS Chemistry Products Calibrator Kit 1 on Description the VITROS Chemistry Systems. The VITROS Ca Slide is a multilayered, analytical element coated on a polyester support. All reactions necessary for a single quantitative measurement of calcium take place within the multi-layered analytical element of a VITROS Chemistry Products Ca slide.
A drop of patient sample is deposited on the VITROS Ca Slide and is evenly distributed by the spreading layer to the underlying layers. The bound calcium is dissociated from binding proteins, allowing the calcium to penetrate through the spreading layer into the underlying reagent layer. In the reagent layer, the calcium forms a complex with Arsenazo III dye, causing a shift in the absorption maximum.
After incubation, the reflection density of the colored complex is measured spectrophotometrically by a VITROS Chemistry System. The amount of colored complex formed is proportional to the calcium concentration in the sample fluid. The test result is reported in milligrams per deciliter (mg/dL) or millimoles per liter (mmol/ L).
VITROS Chemistry Products Calibrator Kit 1 contains three levels of lyophilized standards with corresponding diluents. The standards are prepared from processed bovine serum to which organic analytes, electrolytes, stabilizers, and preservatives have been added. The companion diluents are prepared from processed water to which inorganic salts have been added.
The VITROS Chemistry System and reagents are designed specifically for use with the VITROS Chemistry Products range of products.
-
- Device intended use
VITROS Chemistry Products Ca Slides For in vitro diagnostic use only. VITROS Ca Slides quantitatively measure calcium (Ca) concentration in serum, plasma, and urine.
- Device intended use
VITROS Chemistry Products Calibrator Kit 1
For in vitro diagnostic use only. VITROS Calibrator Kit 1 is used to calibrate 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
510(k) Summary, Continued
- The VITROS Chemistry Products Ca Slide (modified) and VITROS Chemistry Products 7. Comparison Calibrator Kit 1 are substantially equivalent to VITROS Chemistry Products Ca Slide to predicate and VITROS Chemistry Products Calibrator Kit 1, which were Cleared by the FDA for device in vitro diagnostic use.
VITROS Chemistry Products Ca Slide: (K961226, cleared May 7, 1996) VITROS Chemistry Products Calibrator Kit 1: (K023876, cleared December 10, 2002).
Table 1 lists the characteristics of the tests performed using the VITROS Ca Slide (modified) and the VITROS Ca Slide (current).
Table 1. List of VITROS Chemistry Products CaSlide Characteristics: Comparison to Predicate Device
| Device | New Device | Predicate Device |
|---|---|---|
| Characteristic | VITROS Chemistry Products Ca Slide | |
| (Modified) | VITROS Chemistry Products Ca Slide | |
| (Current) | ||
| Intended Use | No Change. | For in vitro diagnostic use only. |
| VITROS Ca Slides quantitatively measure | ||
| calcium (Ca) concentration in serum, plasma, | ||
| and urine. | ||
| Fundamental scientific | ||
| technology | No Change. | Dry, multilayered slide utilizing |
| spectrophotometrics | ||
| Test Type | No Change. | Colorimetric |
| Reactive Ingredients per cm2 | No Change. | Arsenazo III dye 60 µg |
| Sample type | No Change. | Serum, plasma, urine. |
| Instrumentation | No Change. | VITROS 250, 550, 750, 950 and 5,1FS |
| Series Analyzers | ||
| Composition of the | ||
| Spreading Layer* component | ||
| of the VITROS Ca Slide | TiO2: New Supplier | |
| Cellulose Acetate: New lot | ||
| Estane: Increased to 1.7 times the current level, | ||
| i.e. 70% increase. Estane concentration is | ||
| correlated to manufacturability of the VITROS | ||
| Ca Slide. | ||
| Surfactants: No Change. | TiO2, Cellulose Acetate, Estane, Surfactants | |
| Manufacturing Process | ||
| Changes due to the increased | ||
| Estane level in the Spreading | ||
| Layer* Component of the | ||
| VITROS Ca Slide | The increased concentration of Estane raised | |
| the viscosity, requiring modifications to the | ||
| solution delivery system and to the non-solvent | ||
| flow rate. | Current Manufacturing Process. |
*The "Spreading Layer" refers to the spreading layer component of the VITROS Chemistry Products Ca Slide (Refer to Page 2 of the Instructions For Use for VITROS Chemistry Products Ca Shide (Reights). The Spreading Layer even) y discributes sample fluid to the underlying layers of the VITROS Ca Slide,
No modifications were made to VITROS Chemistry Products Calibrator Kit 1.
Continued on next page
3
510(k) Summary, Continued
8. Conclusions
The information presented in the premarket notification demonstrates that the performance of the VITROS Chemistry Products Ca 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 calcium values spanning the assarring and
The information presented in the premarket notification provides a reasonable assurance that the VITROS Chemistry Products Ca 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 features a stylized eagle with three stripes forming its body and wings. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a sans-serif font. The text is arranged around the top and sides of the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 2 0 2007
Ortho-Clinical Diagnostics, Inc. c/o Marlene A. Hanna 100 Indigo Creek Drive Rochester, New York 14626-5101
K072440 Trade/Device Name: VITROS® Chemistry Products Ca Slides VITROS® Chemistry Products Calibrator Kit 1 Regulation Number: 21 CFR§ 862.1145 . Regulation Name: Calcium test system Regulatory Class: Class II Product Code: CJY, JIX Dated: August 29, 2007 Received: August 30, 2007
Dear Ms. Hanna:
Re:
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.
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).
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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 1egally marketed predicate device results in a classification for your device and this, permite 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 (240) 276-0490. Also, please othe the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 80.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tolla the (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Jean M. Cooper, M.S., D.V.M.
Sean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indication for Use
510(k) Number (if known):
Device Name: VITROS Chemistry Products Ca Slides
Indication For Use: For in vitro diagnostic use only. VITROS Ca Slides quantitatively measure calcium (Ca) concentration in serum, plasma, and urine. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone disorders, chronic renal disease and tetany (intermittent muscular contractions or spasms).
Prescription Use_ X (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
Carol C. Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K072440
Page 1 of 2
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Indication for Use
510(k) Number (if known):
Device Name: VITROS Chemistry Products Calibrator Kit 1
Indication For Use: For in vitro diagnostic use only. VITROS Calibrator Kit 1 is used to calibrate the VITROS Chemistry Systems for the quantitative measurement of BUN/UREA, Ca, CREA, GLU, LAC, Li, Mg, PHOS, SALI, THEO, and URIC.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use _ (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Carolf. Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K072440
Page 2 of 2
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