(29 days)
Not Found
No
The device description details a chemical assay using ion-selective electrodes and potentiometry, with a microcomputer performing calculations based on calibration parameters. There is no mention of AI or ML algorithms for data processing, interpretation, or decision-making.
No
The device is for in vitro diagnostic use only, meaning it is used to measure potassium levels in samples outside of the body to aid in diagnosis, not to treat a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use only" and describes how the device measures potassium concentração for "diagnosis and treatment of diseases and conditions".
No
The device description clearly details physical components like slides, calibrators, and a chemistry system, indicating it is a hardware-based in vitro diagnostic device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
The document explicitly states "For in vitro diagnostic use only" multiple times in the "Intended Use / Indications for Use" section.
Furthermore, the description details how the device is used to measure potassium concentration in biological samples (serum, plasma, and urine) to aid in the diagnosis and treatment of medical conditions. This aligns with the definition of an in vitro diagnostic device, which is used to examine specimens from the human body to provide information for diagnosis, treatment, or prevention of disease.
N/A
Intended Use / Indications for Use
The VITROS K* Slides quantitatively measure potassium (K+) concentration in serum, plasma, and urine. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases and conditions characterized by low or high blood potassium levels.
VITROS Calibrator Kit 2 is used to calibrate the VITROS Chemistry Systems for the quantitative measurement of CHOL, CI , ECO2, HDLC, K+, Na+, and TRIG.
Product codes (comma separated list FDA assigned to the subject device)
CEM, JIX
Device Description
The VITROS K assay is performed using the VITROS Chemistry Products K Slide and the VITROS Chemistry Products Calibrator Kit 2 on the VITROS Chemistry Systems. The VITROS K* Slide is a multilayered, analytical element coated on a polyester support that uses direct potentiometry for measurement of ionic potassium. All reactions necessary for a single quantitative measurement of potassium take place within the multi-lavered analytical element of a VITROS Chemistry Products K*slide. The slide consists of two ion-selective electrodes, each containing valinomycin (an ionophore for potassium), a reference layer, and a silver layer and a silver chloride layer coated on a polyester support.
VITROS Chemistry Products K* Slides use ion-selectrodes for potentiometric measurements of ionic potassium. Ionic potassium determinations are made by simultaneously depositing 10 uL each of a reference fluid and a sample fluid on separate halves of the VITROS Chemistry Products K* slide. The electrode receiving the reference fluid is identified as the reference electrode. A paper bridge connects the reference electrode and the indicator electrode, which receives the sample fluid. A stable liquid junction between the two fluids is formed in the paper bridge in approximately 20 seconds. The potassium ions in the tested reference and sample fluids migrate to the silver/ silver chloride layers and establish equilibrium.
After a two minute incubation period, the electrometer in the VITROS Chemistry System measures the potential difference between the reference and indicator electrodes. Each electrode responds to the activity of potassium ions in the respective fluids to produce a potential for the concentration cell. The VITROS Chemistry System's microcomputer uses this measurement and the stored calibration parameters to determine the concentration value of the potassium ion in the sample fluid. The test result is reported in millimoles per liter (mmol/L).
VITROS Chemistry Products Calibrator Kit 2 contains four levels of Iyophilized standards with corresponding diluents. The standards are prepared from processed bovine serum to which bovine cholesterol, chicken egg yolk, inorganic salts, electrolytes, buffers, stabilizers, and preservatives have been added. The companion diluents are prepared from processed water to which inorganic salts have been added. In addition. Calibrator 4 Diluent contains 0.5 M diethylaminoethanol and 0.01 M (ethylenedinitrilo) tetraacetic acid.
The VITROS 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
For in vitro diagnostic use only.
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 potassium 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.
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
§ 862.1600 Potassium test system.
(a)
Identification. A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.(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: 1003157
| 1. | Submitter
name,
address,
contact | Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Drive
Rochester, New York 14626-5101
(585) 453-4041 |
|----|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | Contact Person: Marlene A. Hanna |
| 2. | Preparation
date | Date Special 510(k) prepared: November 7, 2007 |
| 3. | Device
name | Trade or Proprietary Name:
VITROS Chemistry Products K+ Slides
Common Name: Potassium test
Classification Name: Potassium test system (21 CFR 862.1600) |
| | | VITROS Chemistry Products Calibrator Kit 2
Common Name: calibrator
Classification Name: Calibrator (21 CFR 862.1150) |
| 4. | Predicate
device | The VITROS Chemistry Products K+ Slides (modified) and VITROS Chemistry
Products Calibrator Kit 2 are substantially equivalent to the VITROS Chemistry
Products K+ Slides (current slide) and VITROS Chemistry Products Calibrator Kit 2.
The FDA cleared the VITROS Chemistry Products K+ Slides on May 7, 1996
(K961115) under the product name EKTACHEM Clinical Chemistry Slide Potassium
(K+). With the purchase of KODAK Clinical Products Division by Johnson and
Johnson, the product branding was later revised to VITROS Chemistry Products K+
Slides. The most recent FDA clearance for the VITROS Chemistry Products Calibrator
Kit 2 was July 20, 2007 (K071801). |
Continued on next page
1
510(k) Summary, Continued
- Device Description The VITROS K assay is performed using the VITROS Chemistry Products K Slide and the VITROS Chemistry Products Calibrator Kit 2 on the VITROS Chemistry Systems. The VITROS K* Slide is a multilayered, analytical element coated on a polyester support that uses direct potentiometry for measurement of ionic potassium. All reactions necessary for a single quantitative measurement of potassium take place within the multi-lavered analytical element of a VITROS Chemistry Products K*slide. The slide consists of two ion-selective electrodes, each containing valinomycin (an ionophore for potassium), a reference layer, and a silver layer and a silver chloride layer coated on a polyester support.
VITROS Chemistry Products K* Slides use ion-selectrodes for potentiometric measurements of ionic potassium. Ionic potassium determinations are made by simultaneously depositing 10 uL each of a reference fluid and a sample fluid on separate halves of the VITROS Chemistry Products K* slide. The electrode receiving the reference fluid is identified as the reference electrode. A paper bridge connects the reference electrode and the indicator electrode, which receives the sample fluid. A stable liquid junction between the two fluids is formed in the paper bridge in approximately 20 seconds. The potassium ions in the tested reference and sample fluids migrate to the silver/ silver chloride layers and establish equilibrium.
After a two minute incubation period, the electrometer in the VITROS Chemistry System measures the potential difference between the reference and indicator electrodes. Each electrode responds to the activity of potassium ions in the respective fluids to produce a potential for the concentration cell. The VITROS Chemistry System's microcomputer uses this measurement and the stored calibration parameters to determine the concentration value of the potassium ion in the sample fluid. The test result is reported in millimoles per liter (mmol/L).
VITROS Chemistry Products Calibrator Kit 2 contains four levels of Iyophilized standards with corresponding diluents. The standards are prepared from processed bovine serum to which bovine cholesterol, chicken egg yolk, inorganic salts, electrolytes, buffers, stabilizers, and preservatives have been added. The companion diluents are prepared from processed water to which inorganic salts have been added. In addition. Calibrator 4 Diluent contains 0.5 M diethylaminoethanol and 0.01 M (ethylenedinitrilo) tetraacetic acid.
The VITROS System and reagents are designed specifically for use with the VITROS Chemistry Products range of products.
-
- Device VITROS Chemistry Products K+ Slides For in vitro diagnostic use only. VITROS K+ Slides quantitatively measure potassium intended use (K+) concentration in serum, plasma, and urine.
VITROS Chemistry Products Calibrator Kit 2 For in vitro diagnostic use only. VITROS Calibrator Kit 2 is used to calibrate the VITROS Chemistry Systems for the quantitative measurement of CHOL, CI , ECO2, HDLC, K+, Na+, and TRIG.
- Device VITROS Chemistry Products K+ Slides For in vitro diagnostic use only. VITROS K+ Slides quantitatively measure potassium intended use (K+) concentration in serum, plasma, and urine.
Continued on next page
2
510(k) Summary, Continued
- The VITROS Chemistry Products K+ Slide (modified) and VITROS Chemistry 7. Compariso Products Calibrator Kit 2 are substantially equivalent to VITROS Chemistry Products K+ Slide and VITROS Chemistry Products Calibrator Kit 2, which were n to predicate Cleared by the FDA for in vitro diagnostic use. device VITROS Chemistry Products K+ Slide: (K961115, cleared May 7, 1996) VITROS Chemistry Products Calibrator Kit 2: (K071801, cleared July 20, 2007).
Table 1 lists the characteristics of the tests performed using the VITROS K * Slide (modified) and the VITROS K+ Slide (current).
Table 1. List of VITROS Chemistry Products K*Slide Characteristics: Comparison to Predicate Device
| Device | New Device | Predicate Device |
|---|---|---|
| Characteristic | VITROS Chemistry Products K+ Slide | |
| (Modified) | VITROS Chemistry Products K+ Slide | |
| (Current) | ||
| Intended Use | No Change. | For in vitro diagnostic use only. |
| VITROS K+ Slides quantitatively measure | ||
| potassium (K+) concentration in serum, plasma, | ||
| and urine. | ||
| Fundamental scientific | ||
| technology | No Change. | Dry, multilayered slide utilizing direct |
| potentiometry | ||
| Sample type | No Change. | Serum , plasma, urine |
| Instrumentation | VITROS 250, 950 and 5,1FS Series | |
| Analyzers. The 550 and 750 analyzers will | ||
| not be supported by OCD as of January 1, |
- | VITROS 250, 550, 750, 950 and 5,1FS Series
Analyzers |
| Reactive Ingredients per
cm2 | No Change. | Silver 0.4 mg and silver chloride 0.2 mg; sodium
chloride 0.2 mg; potassium chloride 63 μg,
valinomycin 55 μg. |
| Other Ingredients | Binders, plasticizers, stabilizer, surfactants
and nickel-chromium. | Binders, plasticizers, stabilizer, surfactants and
nickel. |
| Composition of ISE
baseweb* component | Ag/AgCl concentration: No change
Nickel Stripes: NiCr (80% Nickel, 20%
Chromium) | Ag/AgCl concentration: Silver 0.4 mg and silver
chloride 0.2 mg
Nickel Stripes: Ni (99+% Nickel) |
| Manufacturing Process of
the ISE baseweb*
(Ag/AgCl and Support
Layers of the K+ Slide) | Magnetic sputter deposition | Electron beam evaporation |
- ISE (lon-Selective Electrode) baseweb= Polyethylene terephthalate film (substrate used for metallized film) coated with silver (Ag)/ silver chloride (Ag/Cl) and striped with nominal nickel (Ni) stripes. The "ISE baseweb" refers to the Ag/ AgCl with nickel stripes layer and support layer of the VITROS Chemistry Products K* Slide.
NOTE: No modifications were made to VITROS Chemistry Products Calibrator Kit 2. VITROS Calibrator Kit 2 is included in this submission, since the VITROS K+ Slide is used in conjunction with VITROS Calibrator Kit 2, and together are considered to be to the "VITROS K+ assay".
3
510(k) Summary, Continued
The information presented in the premarket notification demonstrates that the 8. Conclusions performance of the VITROS Chemistry Products K* 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 potassium values spanning the assay range.
The information presented in the premarket notification provides a reasonable assurance that the VITROS Chemistry Products K* Slides (modified) for use with human serum, plasma, and urine is safe and effective for the stated intended use.
4
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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three branches instead of the usual two.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 0 7 2007
Ortho-Clinical Diagnostics, Inc. c/o Ms. Marlene Hanna Regulatory Affairs Manager MC00881 100 Indigo Creek Drive Rochester, New York 14626-5101
K073157 Re:
Trade/Device Name: Vitros Chemistry Product K+ Slides and Vitros Chemistry Products Calibrator Kit 2 Regulation Number: 21 CFR 862.1600 Regulation Name: Potassium Test System Regulatory Class: Class II Product Code: CEM, JIX Dated: November 07, 2007 Received: November 08, 2007
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.
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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Page 2 -
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 (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (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.
Jean 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
6
Indication for Use
510(k) Number (if known): K073157
Device Name: VITROS Chemistry Products K+ Slides
Indication For Use: For in vitro diagnostic use only. VITROS K* Slides quantitatively measure potassium (K+) concentration in serum, plasma, and urine. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases and conditions characterized by low or high blood potassium levels.
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)
Carol C. Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K073157
Page 1 of 2
7
Indication for Use
510(k) Number (if known): K073157
Device Name: VITROS Chemistry Products Calibrator Kit 2
Indication For Use: For in vitro diagnostic use only. VITROS Calibrator Kit 2 is used to calibrate the VITROS Chemistry Systems for the quantitative measurement of CHOL, CT, ECO2, HDLC, K*, Na*, and TRIG.
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)
Carol C. Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K073157
Page 2 of 2
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