(77 days)
Not Found
No
The device description details a chemical assay using ion-selective electrodes and a microprocessor to calculate results based on measured potential differences and stored calibration parameters. There is no mention of AI or ML algorithms being used for data analysis or interpretation.
No
The device is described as being for "in vitro diagnostic use only," meaning it is used to measure potassium levels in serum and plasma, not to treat a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that potassium measurements are "used to monitor electrolyte balance in the diagnosis and treatment of diseases or conditions characterized by low or high blood potassium levels. For in vitro diagnostic use only." This directly indicates its role in diagnosis.
No
The device description clearly details physical components like slides, calibrator kits, and a chemistry system (VITROS DT60/DT60 II) which are hardware. The software component is described as a microprocessor within the system that processes measurements, but it is integral to the hardware system, not a standalone software device.
Yes, this device is an IVD (In Vitro Diagnostic).
The provided text explicitly states:
- "For in vitro diagnostic use only" in the Intended Use / Indications for Use section for both the VITROS Chemistry Products K* DT Slides and the VITROS Chemistry Products DT Calibrator Kit.
N/A
Intended Use / Indications for Use
VITROS Chemistry Products K* DT Slides quantitatively measure potassium (K+) concentration in serum and plasma using VITROS DT60 and DT60 II Chemistry Systems. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases or conditions characterized by low or high blood potassium levels. For in vitro diagnostic use only,
VITROS Chemistry Products DT Calibrator Kit is specially formulated for use as calibrators for the quantitative measurement of ALB, ALKP, ALT, AMYL, AST, TBIL, NBIL, BUN/UREA, Ca, CHOL, CK, CI-, Co2, CREA, CRSC, Fe, GGT, GLU, HDLC, K+, LAC, LDH, LIPA, Mg, Na+, NH3, PHOS, TP, TRIG, urCR, and URIC on VITROS DT Chemistry Systems. For in vitro diagnostic use only.
Product codes (comma separated list FDA assigned to the subject device)
CEM, JIX
Device Description
The VITROS Chemistry Products K* DT Slide assay is performed using the VITROS Chemistry Products K DT Slide and the VITROS Chemistry Products DT Calibrator Kit on the VITROS DT60/DT60 II Chemistry Systems. The VITROS K+ DT Slide is a multilayered, analytical element coated on a polyester support that uses direct potentiometry' for measurement of potassium ions. All reactions necessary for a single quantitative measurement of potassium take place within the multi-layered analytical element of a VITROS Chemistry Products K DT Slide. The slide consists of two ionselective 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+ DT Slides use ion-selective electrodes 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+ DT 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. The potassium ions in the tested reference and sample fluids migrate to the silver/ silver chloride lavers and establish equilibrium.
After an 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 DT60/DT6011 Chemistry System's microprocessor 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 DT Calibrator Kit contains four levels of lyophilized standards with corresponding diluents. The standards are prepared from bovine serum albumin and processed bovine serum to which enzymes, electrolytes, stabilizers, preservatives and other organic analytes have been added. The companion diluents are prepared from processed water to which inorganic salts have been added.
The VITROS DT60 / DT60 II 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 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
1083680
Summary Information
FEB 2 6 2009
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:
-
- Submitter Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive name, Rochester, New York 14626-5101 address, (585) 453-4041 contact email: mhanna1@ocdus.jnj.com
Contact Person: Marlene A. Hanna
- Submitter Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive name, Rochester, New York 14626-5101 address, (585) 453-4041 contact email: mhanna1@ocdus.jnj.com
-
Date Special 510(k) prepared: December 10, 2008 2. Preparation date
-
Trade or Proprietary Name: 3. Device VITROS Chemistry Products K+ DT Slides name Common Name: potassium test Classification Name: Potassium test system (21 CFR 862.1600)
VITROS Chemistry Products DT Calibrator Kit Common Name: calibrator Classification Name: Calibrator (21 CFR 862.1150)
- The VITROS Chemistry Products K* DT Slides (modified) and VITROS Chemistry 4. Predicate Products DT Calibrator Kit are substantially equivalent to the VITROS Chemistry device Products K* DT Slides (current slide) and VITROS Chemistry Products DT Calibrator Kit.
Continued on next page
1
510(k) Summary, Continued
- Device Description
The VITROS Chemistry Products K* DT Slide assay is performed using the VITROS Chemistry Products K DT Slide and the VITROS Chemistry Products DT Calibrator Kit on the VITROS DT60/DT60 II Chemistry Systems. The VITROS K+ DT Slide is a multilayered, analytical element coated on a polyester support that uses direct potentiometry' for measurement of potassium ions. All reactions necessary for a single quantitative measurement of potassium take place within the multi-layered analytical element of a VITROS Chemistry Products K DT Slide. The slide consists of two ionselective 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+ DT Slides use ion-selective electrodes 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+ DT 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. The potassium ions in the tested reference and sample fluids migrate to the silver/ silver chloride lavers and establish equilibrium.
After an 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 DT60/DT6011 Chemistry System's microprocessor 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 DT Calibrator Kit contains four levels of lyophilized standards with corresponding diluents. The standards are prepared from bovine serum albumin and processed bovine serum to which enzymes, electrolytes, stabilizers, preservatives and other organic analytes have been added. The companion diluents are prepared from processed water to which inorganic salts have been added.
The VITROS DT60 / DT60 II Chemistry System and reagents are designed specifically for use with the VITROS Chemistry Products range of products.
2
VITROS Chemistry Products K* DT Slides 6. Device intended For in vitro diagnostic use only. VITROS K* DT Slides quantitatively measure potassium (K+) concentration in serum and plasma. use
VITROS Chemistry Products DT Calibrator Kit
For in vitro diagnostic use only. VITROS Chemistry Products DT Calibrator Kit is specially formulated for use as calibrators for the quantitative measurement of ALB, ALKP, ALT, AMYL, AST, TBIL, NBIL, BUN/UREA, Ca, CHOL, CK, CI-, Co2, CREA, CRSC, Fe, GGT, GLU, HDLC, K+, LAC, LDH, LIPA, Mg, Na+, NH3, PHOS, TP, TRIG, urCR, and URIC on VITROS DT Chemistry Systems.
Continued on next page
3
510(k) Summary, Continued
The VITROS Chemistry Products K DT Slide (modified) and VITROS Chemistry 7. Comparison Products DT Calibrator Kit are substantially equivalent to VITROS Chemistry to predicate Products K* DT Slide and VITROS Chemistry Products DT Calibrator Kit, which were device Cleared by the FDA for in vitro diagnostic use.
VITROS Chemistry Products K'DT Slide: (K912844, cleared September 4, 1991) VITROS Chemistry Products DT Calibrator Kit:(K082099, cleared August 21, 2008).
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 DT Slide Characteristics: Comparison to Predicate Device
| Device
Characteristic | New Device
VITROS Chemistry Products K⁺ DT Slide
(Modified) | Predicate Device
VITROS Chemistry Products K⁺ DT Slide
(Current) |
|--------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | No Change. | For in vitro diagnostic use only.
VITROS K⁺DT Slides quantitatively measure
potassium (K⁺) concentration in serum and
plasma. |
| Fundamental
scientific
technology | No Change. | Dry, multilayered slide utilizing direct
potentiometry |
| Reactive
Ingredients per cm² | No Change. | Silver 0.4 mg; silver chloride 0.2 mg; sodium
chloride 0.2 mg; potassium chloride 63 µg; and
valinomycin 55 µg. |
| Sample type | No Change. | Serum, plasma |
| Instrumentation | No Change. | VITROS DT Systems |
| Manufacturing
Process of the ISE
baseweb* (Ag/AgCl
and Support Layers
of the Cl⁻ DT Slide) | Magnetic sputter deposition | Electron beam evaporation |
| 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) |
*ISE (Ion-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+ DT Slide.
No modifications were made to VITROS Chemistry Products DT Calibrator Kit.
Continued on next page
4
510(k) Summary, Continued
- Conclusions
The information presented in the premarket notification demonstrates that the performance of the VITROS Chemistry Products K* DT 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 potassium values spanning the assay range.
The information presented in the premarket notification provides a reasonable assurance that the VITROS Chemistry Products K* DT Slides (modified) for use with human serum and plasma is safe and effective for the stated intended use.
5
Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ortho-Clinical Diagnostics Inc. c/o Marlene Hanna Regulatory Affairs Manager 100 Indigo Creek Drive MC00882 Rochester, NY 14626-5101
FEB 2 6 2009
Re: K083680
Trade/Device Name: VITROS Chemistry Products K+ DT Slides VITROS Chemistry Products DT Calibrator Kit
Regulation Number: 21 CFR 862.1600 Regulation Name: Potassium test system Regulatory Class: Class II Product Code: CEM, JIX Dated: January 26, 2009 Received: January 27, 2009
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. Iisting 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),
6
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 I legal] 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). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tolloft and (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Corg C. He
Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
7
Indication for Use
KO83680
510(k) Number (if known):
Device Name: VITROS Chemistry Products K+ DT Slides VITROS Chemistry Products DT Calibrator Kit
Indications for Use: VITROS Chemistry Products K* DT Slides quantitatively measure potassium (K+) concentration in serum and plasma using VITROS DT60 and DT60 II Chemistry Systems. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases or conditions characterized by low or high blood potassium levels. For in vitro diagnostic use only,
VITROS Chemistry Products DT Calibrator Kit is specially formulated for use as calibrators for the quantitative measurement of ALB, ALKP, ALT, AMYL, AST, TBIL, NBIL, BUN/UREA, Ca, CHOL, CK, CI-, Co2, CREA, CRSC, Fe, GGT, GLU, HDLC, K+, LAC, LDH, LIPA, Mg, Na+, NH3, PHOS, TP, TRIG, urCR, and URIC on VITROS DT Chemistry Systems. For in vitro diagnostic use only.
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)
Ruti chalin
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K083680
Page 1 of 1