ACCESS OSTASE IMMUNOENZYMETRIC ASSAY
FDA 510(k) clearance K994278 · decided 2000-03-28
Clearance details
- K-number
- K994278
- Device name
- ACCESS OSTASE IMMUNOENZYMETRIC ASSAY
- Applicant
- Beckman Coulter, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-12-20
- Decision date
- 2000-03-28
- Days to decision
- 99 days
- Clearance type
- Traditional
- Product code
- CIN
- Device class
- 2
- Regulation number
- 862.1050
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Access Ostase (K232904) | Beckman Coulter | 2024-04-15 |
| IDS-iSYS Ostase BAP (K200475) | Immunodiagnostic Systems , Ltd. | 2020-09-30 |
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| ALKPHASE-B ASSAY KIT (K981373) | Metra Biosystems, Inc. | 1998-05-27 |
| TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY (K972666) | Hybritech, Inc. | 1997-09-11 |
| OPUS BONE ALP (K964764) | Behring Diagnostics, Inc. | 1997-01-24 |
| TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY (K961573) | Hybritech, Inc. | 1996-08-19 |
| ALKPHASE-B ASSAY KIT (K952768) | Metra Biosystems, Inc. | 1995-08-24 |
| RESOLVE SYSTEMS ALKALINE PHOSPHATASE TEST KIT (K934013) | Isolab, Inc. | 1994-04-26 |
| TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY (K930810) | Hybritech, Inc. | 1994-01-11 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Access Ostase Calibrators, Part Number: 37305, Subsequent Product Code: JIS. The Access Os recall (Z-1238-2012) | Beckman Coulter Inc. | 2012-03-21 |
| Access Ostase Reagent, Part Number: 37300, subsequent product code: JIS. The Access Ostase recall (Z-1240-2012) | Beckman Coulter Inc. | 2012-03-21 |
| ACCESS Ostase Part Number: 37300 Used for the quantitative measurement of bone alkaline ph recall (Z-1195-2012) | Beckman Coulter Inc. | 2012-03-09 |
| Access Immunoassay Systems Ostase Calibrators, Part Number: 37305 The Access Ostase Calibr recall (Z-2605-2011) | Beckman Coulter Inc. | 2011-06-21 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Access AFP (on DxI 9000 Analyzer) (P980041/S051) | Beckman Coulter, Inc. | 2025-11-03 |
| Access HBsAg, Access HBsAg Confirmatory, Access HBsAg Calibrator, Access HBsAg QC (P230015) | Beckman Coulter, Inc. | 2025-10-17 |
| Access Hybritech p2PSA (P090026/S032) | Beckman Coulter, Inc. | 2025-06-16 |
| Access Hybritech free PSA (P970038/S046) | Beckman Coulter, Inc. | 2025-05-15 |
| Access Hybritech PSA (P850048/S060) | Beckman Coulter, Inc. | 2024-09-04 |
| Access Hybritech PSA reagent pack (P850048/S059) | Beckman Coulter, Inc. | 2023-05-25 |
| Access AFP Reagents on the Access Immunoassay Systems (P980041/S050) | Beckman Coulter, Inc. | 2022-12-16 |
| Access Hybritech PSA Reagents on the Access Immunoassay Systems (P850048/S057) | Beckman Coulter, Inc. | 2022-12-16 |