# K032608: Gonotec Calibration Solution 300 Mosmol/KG for Osmometer

- Pathway: 510(k) (Abbreviated)
- Applicant: Gonotec Gesellschaft Fuer Mess-Und Regeltechnik MB
- Decided: Oct 21, 2003 after 57 days
- Product code: JIS (Calibrator, Primary)
- Device class: 2
- Regulation: 21 CFR 862.1150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K931834 (1993). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931834: King Sodium/Potassium Standard Modified, King Diagnostics, Inc. (1993) Summary page 1.

## Indications for use
IVD DEVICE CALIBRATION IS MOST COMMONLY PERFORMED USING CALIBRATORS (REFERENCE MATERIALS) SPECIFICALLY INTENDED TO BE USED AS A STANDARD CURVE OR CUT-OFF POINT FOR AN ASSAY. A CALIBRATOR HAS AN ASSIGNED VALUE THAT IS ESTABLISHED BY THE MANUFACTURER BY A REFERENCE METHOD. CALIBRATORS EXIST IN A VARIETY OF MATRICES SUCH AS SIMULATED AQUEOUS, SERUM, PLASMA OR OTHER TYPES OF SPECIMENS. PRIMARY REFERENCE CALIBRATORS ARE HIGHLY PURIFIED CHEMICALS THAT CAN BE DIRECTLY WEIGHED OR MEASURED TO PRODUCE A SOLUTION OF KNOWN CONCENTRATION. ALTERNATIVELY, THEY MAY BE MORE COMPLEX BIOLOGICAL MATERIALS HAVING RECEIVED A VALUE ASSIGNMENT USING REFERENCE (STANDARD) METHODOLOGY. THEY ARE SUPPLIED WITH A CERTIFICATE OF ANALYSIS FOR EACH LOT (FOR EXAMPLE, STANDARD REFERENCE MATERIALS (SRMS) FROM THE U.S. NATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGY (NIST)). THE PRIMARY CALIBRATOR “CALIBRATION SOLUTION FOR OSMOMAT 010 / 030 / auto” IS USED TO CALIBRATE THE OSMOMETERS “OSMOMAT 030” AND “OSMOMAT AUTO”, WHICH BOTH ARE FREEZING-POINT OSMOMETERS FOR USE IN CLINICAL CHEMISTRY. THE OSMOLALITY OF THE CALIBRATOR IS EQUAL TO THE OSMOLALITY OF BODY-FLUIDS (ISOTONIC SOLUTION), PROVIDING THAT THE OSMOMETER WILL BE CALIBRATED CORRECTLY FOR THE FLUIDS TO BE MEASURED FOR MEDICAL PURPOSES.

Source page: https://510kreport.com/device/K032608
Methodology: https://510kreport.com/methodology