510(k) · Cleared
ClearedB R a H M S PCT Sensitive Kryptor Test System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brahms Aktiengesellschaft · NTM Antigen, Inflammatory Response Marker, Sepsis
Cleared on Mar 31, 2008 as substantially equivalent to K040887 (Brahms Aktiengesellschaft, 2005) after a 424-day review. Its family tree reaches back 2 generations to 2003. 1 later device descends from it.
- Decided
- Mar 31, 2008
- Review
- 424 days
- Class
- Class II
- Product code
- NTM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN030002 (2003). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backDEN030002 Endotoxin Activity Assay (Eaa) DeviceSpectral Diagnostics, Inc. · 2003
- 1 generation backK040887 B-R-a-H-M-S PCT LiaBrahms Aktiengesellschaft · 2005
- This deviceK070310 B R a H M S PCT Sensitive Kryptor Test SystemBrahms Aktiengesellschaft · 2008
- Descendant · cites it directly · 0 of its ownK240041 IVD CAPSULE PSP; abioSCOPEAbionic SA · 2024
Most influential descendants
Showing 1 of 1 · See all- K240041IVD CAPSULE PSP; abioSCOPEAbionic SA · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN030002 | Endotoxin Activity Assay (Eaa) Device | Spectral Diagnostics, Inc. | 2003 | — |
| −1 | K040887 | B-R-a-H-M-S PCT Lia | Brahms Aktiengesellschaft | 2005 | — |
| 0 (this device) | K070310 | B R a H M S PCT Sensitive Kryptor Test System | Brahms Aktiengesellschaft | 2008 | — |
| +1 | K240041 | IVD CAPSULE PSP; abioSCOPE | Abionic SA | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 NTM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K040887 | B-R-a-H-M-S PCT LiaSummary page 1…te Device Manufacturer Product Name 510(k) No. BR.A.H.M.S Aktiengesellschaft B-R.A.H.M.S PCT LIA K040887 Device Description The BR.A.H-M-S PCT sensitive KRYPTOR® assay is a homogeneous sandwich immunoassay for detectio… | 2005 |
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 |
|---|---|---|---|
| K240041 | IVD CAPSULE PSP; abioSCOPE | 2024 | 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?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 3.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K240041 (Abionic SA, 2024) has gone furthest, with 0 descendants of its own.
How does its category compare?
All NTM devicesNTM Antigen, Inflammatory Response Marker, Sepsis: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · NTM
1in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · NTM
Too few NTM 510(k)s in any year since 2007 to give a median.
Recalls per year · NTM
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NTM
2in 2024
MAUDE reports naming product code NTM, 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 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 1 | 0 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The B.R.A.H.M.S PCT sensitive KRYPTOR® is designed for automated detection of PCT (procalcitonin) in human serum or plasma (EDTA, heparin) samples by the immunofluorescent B.R.A.H.M.S PCT sensitive KRYPTOR® assay.
The B.R.A.H.M.S PCT sensitive KRYPTOR® is intended for use in conjunction with other laboratory findings and clinical assessments to aid in the risk assessment of critically ill patients on their first day of ICU admission for progression to severe sepsis and septic shock.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070310 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070310: B R a H M S PCT Sensitive Kryptor Test System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070310
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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