Aptima®
Aptima® CT assay, 100 test, box 2 of 2 (15°C to 30°C box). The Aptima® Chlamydia trachomatis assay is a target amplification nucleic acid probe test that utilizes target capture for the in…
Aptima® CT assay, 100 test, box 2 of 2 (15°C to 30°C box). The Aptima® Chlamydia trachomatis assay is a target amplification nucleic acid probe test that utilizes target capture for the in vitro qualitative detection of ribosomal RNA (rRNA) from Chlamydia trachomatis (CT) to aid in the diagnosis of chlamydial urogenital disease using the Tigris® DTS® Automated Analyzer or semi-automated instrumentation as specified.
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hochuen Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 20 |
Record
| Listed by | Hologic, Inc., United States |
|---|---|
| FDA product code | MKZ |
| Device type | Dna Probe, Nucleic Acid Amplification, Chlamydia |
| Device class | Class 1 |
| Regulation | 21 CFR 866.3120 |
| Establishment | Remanufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K132251 |
| Record published | 2016-03-16 |
| Record revised | 2024-06-11 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
| Distribution end date | 2024-01-12 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| KIT, BX 1 (REF) ACT, 100T, AS, IVD | In distribution | ||
| KIT, ASSAY FLUIDS, APTIMA, AS | In distribution | ||
| Aptima Specimen Transfer for Liquid Pap | In distribution | ||
| KIT, BOX 2, RT, ACT, 100-T, AS, IVD | In distribution | ||
| APTIMA URINE COLLECTION TUBES | 100 | In distribution | |
| KIT,APTIMA CT ASSAY SPEC RGTS | Withdrawn | ||
| KIT,APTIMA CT ASSAY FLUIDS | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Aptima Combo 2® | Hologic, Inc. | 4 |
| Alinity m | Abbott Molecular, Inc. | 2 |
| Multi-Collect | Abbott Molecular, Inc. | 1 |
| cobas z 480 | Roche Molecular Systems, Inc. | 1 |
| BD ProbeTec™ Chlamydia trachomatis Qx Assay Gray Amp Reagent Pack | Becton, Dickinson AND Company | 1 |
| BD Molecular Swab Sample Buffer Tubes | Becton, Dickinson AND Company | 1 |
| cobas® PCR Media Uni Swab Sample Kit | Roche Molecular Systems, Inc. | 1 |
| BD Molecular LBC Sample Buffer Tubes | Becton, Dickinson AND Company | 1 |
| cobas Ctng Qualitative nucleic acid test for use on the cobas 6800/8800 Systems | Roche Molecular Systems, Inc. | 1 |
| Progensa | Hologic, Inc. | 1 |
| BD CTGCTV2 | Becton, Dickinson AND Company | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K230451 | 2023-11-16 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Hologic, Inc. | 510(k) number | 2018-01-20 | Class II | Device Design | The Panther or the Panther Fusion glass panel separates from the 19 inch touch screen monitor and could potentially fall and hit an operator. | 103 units | 2022-07-28 |
| Hologic, Inc. | 510(k) number | 2017-09-15 | Class II | Employee error | An incorrect incubator was installed on one Panther System which potentially led to incorrect Aptima Combo 2(R) assay (AC2) results. | 1 unit | 2020-07-30 |
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.