510(k) · Cleared
ClearedFrend Psa Plus (Reagent Cartridge)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nanoentek, Inc. · LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
Cleared on May 29, 2013 as substantially equivalent to P910065 (Tosoh Bioscience, Inc., 1993) after a 149-day review. Its family tree reaches back 1 generation to 1993. 1 later device descends from it.
- Decided
- May 29, 2013
- Review
- 149 days
- Class
- Class II
- Product code
- LTJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to P910065 (1993). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K162378FREND PSA PLUS (reagent cartridge)Nanoentek USA, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P910065 | Aia-Pack Psa | Tosoh Bioscience, Inc. | 1993 | 1 |
| 0 (this device) | K124056 | Frend Psa Plus (Reagent Cartridge) | Nanoentek, Inc. | 2013 | — |
| +1 | K162378 | FREND PSA PLUS (reagent cartridge) | Nanoentek USA, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
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 LTJ? 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 LTJ device
- #1 K251630 Atellica IM Total PSA II (tPSAII)score 10.6 · 1 generation · no Class I recall
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 |
|---|---|---|---|
| * | P910065 | Aia-Pack PsaSummary page 2…duct Code(s): For the assay: LTJ Tumor Associated Antigen Immunologic Test System For the instrument: KHO Fluorometer PredicateDevice: TOSOH ST AlA-PACK PA (P910065/S004) Intended Use: The FRENDTM PSA Plus performed on the FRENDTM system, is a quantitative in vitro diagnostic test which meas… | 1993 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162378 | FREND PSA PLUS (reagent cartridge) | 2017 | 0 |
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 a recall.
- Of its descendants, K162378 (Nanoentek USA, Inc., 2017) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LTJ devicesLTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · LTJ
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LTJ
Too few LTJ 510(k)s in any year since 2007 to give a median.
Recalls per year · LTJ
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LTJ
14in 2025
MAUDE reports naming product code LTJ, 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 | 0 | — | 0 | 17 |
| 2008 | 0 | — | 3 | 57 |
| 2009 | 0 | — | 0 | 58 |
| 2010 | 0 | — | 2 | 34 |
| 2011 | 0 | — | 0 | 109 |
| 2012 | 0 | — | 0 | 101 |
| 2013 | 1 | — | 1 | 69 |
| 2014 | 0 | — | 0 | 19 |
| 2015 | 0 | — | 0 | 14 |
| 2016 | 2 | — | 0 | 8 |
| 2017 | 10 | — | 0 | 13 |
| 2018 | 7 | — | 0 | 8 |
| 2019 | 2 | — | 0 | 11 |
| 2020 | 1 | — | 0 | 4 |
| 2021 | 2 | — | 0 | 8 |
| 2022 | 0 | — | 0 | 11 |
| 2023 | 2 | — | 0 | 17 |
| 2024 | 3 | — | 0 | 8 |
| 2025 | 3 | — | 1 | 14 |
| 2026 | 3 | — | 0 | — |
What is it indicated for?
The FRENDTM PSA Plus as performed on the FRENDTM system, is a quantitative in vitro diagnostic test which measures total Prostate Specific Antigen (PSA) in human serum and plasma. The NanoEnTek FRENDTM PSA Plus is designed for in vitro DIAGNOSTIC USE ONLY. for the quantitative measurement of total Prostate Specific Antigen (PSA) in human serum, heparinized plasma, and EDTA plasma using the FRENDTM System. This device is indicated for the serial…
Read the full statement (187 words)
The FRENDTM PSA Plus as performed on the FRENDTM system, is a quantitative in vitro diagnostic test which measures total Prostate Specific Antigen (PSA) in human serum and plasma. The NanoEnTek FRENDTM PSA Plus is designed for in vitro DIAGNOSTIC USE ONLY. for the quantitative measurement of total Prostate Specific Antigen (PSA) in human serum, heparinized plasma, and EDTA plasma using the FRENDTM System. This device is indicated for the serial measurement of total PSA in serum, heparinized plasma and EDTA plasma to be used as an aid in the management of patients with prostate cancer.
The FRENDTM PSA Plus is indicated for use in clinical laboratories upon prescription by the attending physician as an aid to clinicians in managing patients with prostate cancer.
The information provided from this test may supplement decision-making and should only be used in conjunction with routine monitoring by a physician and the use of other diagnostic procedures. Because of the variability in the effects of various medications used in the treatment of prostate cancer, clinicians should use professional judgment in the interpretation of PSA results as an indicator of disease status.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K124056 · printed Nov 6, 2026
Cite this page
510(k) Report. “K124056: Frend Psa Plus (Reagent Cartridge).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K124056
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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