510(k) · Cleared
ClearedAptima HCV Quant Dx Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hologic, Inc. · MZP Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
Cleared on Jul 24, 2024 as substantially equivalent to P160023 (Hologic, Inc., 2017) after a 299-day review. Its family tree reaches back 1 generation to 2017.
- Decided
- Jul 24, 2024
- Review
- 299 days
- Class
- Class II
- Product code
- MZP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to P160023 (2017). No later device cites it as a predicate yet.
- Root · 1 generation backP160023 Aptima HCV Quant DX AssayHologic, Inc. · 2017
- This deviceK233352 Aptima HCV Quant Dx AssayHologic, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P160023 | Aptima HCV Quant DX Assay | Hologic, Inc. | 2017 | — |
| 0 (this device) | K233352 | Aptima HCV Quant Dx Assay | Hologic, Inc. | 2024 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MZP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MZP device
- #1 K252484 cobas HCVscore 10.6 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | P160023 | Aptima HCV Quant DX AssaySummary page 4…ory Class: Class II Product Code: MZP III. PREDICATE DEVICE The predicate device is the Aptima HCV Quant Dx assay; P160023, originally approved as a Class III PMA product, reclassified to a Class II 510(k) product on November 26, 2021. K233352-S002… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All MZP devicesMZP Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · MZP
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MZP
Too few MZP 510(k)s in any year since 2007 to give a median.
Recalls per year · MZP
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MZP
12in 2025
MAUDE reports naming product code MZP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 5 | — | 1 | 0 |
| 2008 | 12 | — | 0 | 6 |
| 2009 | 11 | — | 0 | 12 |
| 2010 | 19 | — | 0 | 11 |
| 2011 | 20 | — | 2 | 44 |
| 2012 | 17 | — | 0 | 26 |
| 2013 | 24 | — | 0 | 36 |
| 2014 | 12 | — | 0 | 13 |
| 2015 | 12 | — | 0 | 1 |
| 2016 | 21 | — | 0 | 12 |
| 2017 | 15 | — | 0 | 5 |
| 2018 | 30 | — | 0 | 4 |
| 2019 | 35 | — | 0 | 5 |
| 2020 | 18 | — | 0 | 1 |
| 2021 | 8 | — | 4 | 1 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 0 | — | 1 | 1 |
| 2024 | 1 | — | 0 | 2 |
| 2025 | 2 | — | 0 | 12 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Aptima HCV Quant Dx assay is a real-time transcription-mediated amplification (TMA) test used for both detection and quantitation of hepatitis C virus (HCV) RNA in fresh and frozen human serum and plasma from HCV-infected individuals. Plasma may be prepared in ethylenediaminetetraacetic acid (EDTA), anticoagulant citrate dextrose (ACD) solution, and plasma preparation tubes (PPT). Serum may be prepared in serum tubes and serum separator tubes (SST).…
Read the full statement (321 words)
The Aptima HCV Quant Dx assay is a real-time transcription-mediated amplification (TMA) test used for both detection and quantitation of hepatitis C virus (HCV) RNA in fresh and frozen human serum and plasma from HCV-infected individuals.
Plasma may be prepared in ethylenediaminetetraacetic acid (EDTA), anticoagulant citrate dextrose (ACD) solution, and plasma preparation tubes (PPT). Serum may be prepared in serum tubes and serum separator tubes (SST). Specimens are tested using the Panther system for automated specimen processing, amplification, detection, and quantitation. Specimens containing HCV genotypes 1 to 6 are validated for detection and quantitation in the assay.
The Aptima HCV Quant Dx assay is indicated for use as an aid in the diagnosis of active HCV infection in the following populations: individuals with antibody evidence of HCV infection with evidence of liver disease, individuals suspected to be actively infected with HCV antibody evidence, and individuals at risk for HCV infection with antibodies to HCV. Detection of HCV RNA indicates that the virus is replicating and, therefore, is evidence of active infection. Detection of HCV RNA does not discriminate between acute and chronic states of infection.
The Aptima HCV Quant Dx assay is also indicated for use as an aid in the management of HCV infected patients undergoing HCV antiviral drug therapy. The assay can be used to measure HCV RNA levels periodically prior to, during, and after treatment to determine sustained virological response (SVR) or nonsustained virological response (NSVR). Assay performance characteristics have been established for individuals infected with HCV and treated with certain direct-acting antiviral agents (DAA) regimens. No information is available on the assay’s predictive value when other therapies are used. The results from the Aptima HCV Quant Dx assay must be interpreted within the context of all relevant clinical and laboratory findings.
The Aptima HCV Quant Dx assay is not approved for use as a screening test for the presence of HCV RNA in blood or blood products.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233352 · printed Nov 4, 2026
Cite this page
510(k) Report. “K233352: Aptima HCV Quant Dx Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K233352
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026