FDA product code CKB: Acid Phosphatase, Naphthyl Phosphate
CKB is the FDA product code for acid phosphatase, naphthyl phosphate. It is a Class II device, regulated under 21 CFR 862.1020 and reviewed by the Clinical Chemistry panel. FDA has cleared 24 510(k) submissions under CKB, from 22 different applicants. The average 510(k) review took 84 days (median 50). FDA has posted 2 recalls for CKB devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Acid Phosphatase, Naphthyl Phosphate |
| Device class | Class II |
| Regulation | 21 CFR 862.1020 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Top CKB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Olympus America, Inc. | 2 | 1998-06-09 |
| Data Medical Associates, Inc. | 2 | 1986-05-29 |
| Beckman Coulter, Inc. | 1 | 2006-04-26 |
| Bayer Diagnostics Corp. | 1 | 2003-01-07 |
| Abbott Diagnostics Mfg., Inc. | 1 | 1999-05-19 |
17 more applicants have CKB clearances. See the full list in Caduvo.
Most recent CKB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K053612 | Beckman Coulter, Inc. | DRI-STAT ACID PHOSPHATASE REAGENT | 2006-04-26 | 120 |
| K023840 | Bayer Diagnostics Corp. | ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650 | 2003-01-07 | 50 |
| K991010 | Abbott Diagnostics Mfg., Inc. | ACP | 1999-05-19 | 54 |
| K981743 | Olympus America, Inc. | OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER | 1998-06-09 | 22 |
| K974695 | Roche Diagnostic Systems, Inc. | COBRAS INTEGRA ACID PROSTATIC PHOSPHATASE (ACPP) COBAD INTEGRA BENZODIAZEPINES WITH B-GLUCURONIDASE (BNZGL) | 1998-05-21 | 156 |
Recalls for CKB devices
2 product recalls in 2 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-04-30.
| Year | Recalls |
|---|---|
| 2025 | 1 |
Frequently asked questions
What is FDA product code CKB?
CKB is the FDA product code for acid phosphatase, naphthyl phosphate. It is a Class II device, regulated under 21 CFR 862.1020 and reviewed by the Clinical Chemistry panel.
What device class is CKB?
Class II, regulation 21 CFR 862.1020. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CKB?
Across 24 cleared submissions the average was 84 days from receipt to decision (median 50).
Which companies have the most CKB clearances?
Olympus America, Inc. (2); Data Medical Associates, Inc. (2); Beckman Coulter, Inc. (1); Bayer Diagnostics Corp. (1); Abbott Diagnostics Mfg., Inc. (1).
Have CKB devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2025-04-30.
Next steps
- Run an FDA pathway report with predicate devices for product code CKB
- Run a recall and safety report across every CKB manufacturer
- Watch product code CKB for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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