Ph Electrode Calibrating Buffers-Blood
by Bionostics, Inc. 510(k)
Active
510(k) K840299
Overview
This device is a Calibrator, Primary (per FDA nomenclature) designed for the calibration of pH electrodes. It provides standardized buffer solutions specifically formulated for blood pH measurements, ensuring accurate electrode performance in clinical chemistry applications.
The PH Electrode Calibrating Buffers – Blood are supplied as single-use solutions and are intended for use in laboratory settings. They are classified as Class II devices under FDA regulations (21 CFR 862.1150) and were granted FDA 510(k) clearance (K840299) under the Traditional pathway. No MRI safety or sterility specifications are noted in the regulatory data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK840299 | Date23 Mar 1984 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- JIS
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1150
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Bionostics, Inc.
Questions
What is the primary purpose of the PH Electrode Calibrating Buffers – Blood, and where are they used?
The PH Electrode Calibrating Buffers – Blood are designed as a primary calibrator for pH electrodes, ensuring accurate and reliable measurements in clinical chemistry settings. They are specifically formulated for blood pH calibration, which is critical for maintaining precision in laboratory diagnostics. These buffers are intended exclusively for use in laboratory environments to standardize electrode performance.
Are these buffers single-use or reusable, and how should they be stored?
The PH Electrode Calibrating Buffers – Blood are single-use solutions, meaning each vial is intended for one calibration procedure only. While the regulatory data does not specify storage conditions, typical pH buffer solutions should be stored in a cool, dry place away from direct light to preserve stability. Always follow the manufacturer’s instructions (Bionostics, Inc.) for optimal storage and handling.
What regulatory pathway was followed for FDA clearance, and what does this mean for clinical use?
The PH Electrode Calibrating Buffers – Blood received FDA 510(k) clearance (K840299) under the Traditional pathway, meaning the device was determined to be substantially equivalent to a legally marketed predicate device. This clearance confirms the device meets FDA safety and effectiveness standards for use as a primary calibrator in clinical chemistry, ensuring reliability for blood pH measurements in regulated laboratory settings.
Are there multiple sizes or models available for these calibrating buffers?
The regulatory data lists multiple FEI numbers (e.g., 3003565434, 3004192065), which typically correspond to different lot or batch identifiers rather than distinct sizes or models. However, no explicit size or model variations (e.g., different pH values or volumes) are described in the provided data. For specific formulations or quantities, refer to Bionostics, Inc.’s product documentation or catalog.
Do these buffers require any special handling, such as sterility or compatibility with specific electrode types?
The regulatory data does not mention sterility requirements, indicating these buffers are non-sterile solutions intended for laboratory calibration only—not for direct patient use. They are formulated specifically for blood pH electrode calibration and should be compatible with standard clinical chemistry pH electrodes. Always verify compatibility with your specific electrode model before use, as electrode manufacturers may have additional recommendations.