Advanced Instruments A2O System Fluid
A2O System Fluid is used for system cleaning during automated osmolality testing
4manufacturers in China registered for this device type
1catalogue number
7510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Shandong (2), Guangdong (1), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangzhou Four E’s Scientific Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 61 |
| Infitek Co., Ltd. | Shanghai | Shanghai | Manufacturer | 49 |
| Labpeak Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Scitek Global Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
Record
| Listed by | Advanced Instruments, LLC, United States |
|---|---|
| FDA product code | JJM |
| Device type | Osmometer For Clinical Use |
| Device class | Class 1 |
| Regulation | 21 CFR 862.2730 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-09-21 |
| Record revised | 2026-06-18 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 200222 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| FreezePoint® Freezing Point Osmometer | ELITechGroup Inc | 4 |
| Multi-OSMETTE | Precision Systems, Inc. | 3 |
| Micro-OSMETTE | Precision Systems, Inc. | 2 |
| Advanced Instruments OsmoPRO Multi-Sample Micro-Osmometer | Advanced Instruments, LLC | 2 |
| Osmette Sample Tubes, 30 ul | Precision Systems, Inc. | 2 |
| Osmette III | Precision Systems, Inc. | 2 |
| Osmette XL | Precision Systems, Inc. | 2 |
| Advanced Instruments Model 3250 Single-Sample Osmometer Sample Tubes, Box of 500 | Advanced Instruments, LLC | 2 |
| Osmette A | Precision Systems, Inc. | 2 |
| Touch Micro-OSMETTE | Precision Systems, Inc. | 1 |
| Multi-OSMETTE Carousel, Spare | Precision Systems, Inc. | 1 |
| Micro-OSMETTE Sample Tubes, 50 ul | Precision Systems, Inc. | 1 |
Showing 12 of 60. All products under Osmometer For Clinical Use
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K965036 | 1997-02-20 |
| K962056 | 1996-07-11 |
| K925970 | 1993-07-09 |
| K911092 | 1991-05-22 |
| K873642 | 1987-10-20 |
| K832783 | 1983-11-28 |
| K790611 | 1979-06-15 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2024-03-11 | Class II | Under Investigation by firm | System error messages may delay the ability to test patient samples and the need for frequent calibration due to results outside the expected range when testing controls. | 58 units |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.