510(k) · Cleared
ClearedQuantia A1-at
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biokit, S.A. · DEM Alpha-1-Antitrypsin, Antigen, Antiserum, Control
Cleared on May 13, 2005 as substantially equivalent to K860894 (Behring Diagnostics, Inc., 1986) after a 66-day review. Its family tree reaches back 1 generation to 1986.
- Decided
- May 13, 2005
- Review
- 66 days
- Class
- Class II
- Product code
- DEM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K860894 (1986). No later device cites it as a predicate yet.
- Root · 1 generation backK860894 Behring Nephelometer SystemBehring Diagnostics, Inc. · 1986
- This deviceK050596 Quantia A1-atBiokit, S.A. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K860894 | Behring Nephelometer System | Behring Diagnostics, Inc. | 1986 | — |
| 0 (this device) | K050596 | Quantia A1-at | Biokit, S.A. | 2005 | — |
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 DEM? 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 |
|---|---|---|---|
| * | K860894 | Behring Nephelometer SystemSummary page 1…ntitrypsin immunological test system Class II DEM Alpha-l-Antitrypsin, Antigen, Antiserum, Control Identification of predicate device(s): K860894 N Antisera to Human alpha-l-Antitrypsin (Dade Behring) Description of the device/intended use(s): The Quantia Al-AT is in… | 1986 |
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.
- 16 other devices also cite its predicate K860894.
How does its category compare?
All DEM devicesDEM Alpha-1-Antitrypsin, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DEM
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · DEM
Too few DEM 510(k)s in any year since 2007 to give a median.
Recalls per year · DEM
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DEM
1in 2024
MAUDE reports naming product code DEM, 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 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 1 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Quantia Al-AT is intended for the in vitro quantitative determination of alpha-l-antitrypsin concentration in human serum or plasma (hepariR with or without gel separator, EDTA) on the AEROSET® system as an aid in the diagnosis of juvenile and adult cirrhosis of the liver and pulmonary emphysema. Quantia PROTEINS Control is intended for use in monitoring the quality control of results obtained with the Quantia Al-AT reagents by turbidimetry. (NOTE…
Read the full statement (113 words)
The Quantia Al-AT is intended for the in vitro quantitative determination of alpha-l-antitrypsin concentration in human serum or plasma (hepariR with or without gel separator, EDTA) on the AEROSET® system as an aid in the diagnosis of juvenile and adult cirrhosis of the liver and pulmonary emphysema.
Quantia PROTEINS Control is intended for use in monitoring the quality control of results obtained with the Quantia Al-AT reagents by turbidimetry. (NOTE: This control has been also FDA 510(k) submitted for use with Quantia Beta-2 Microglobulin). For in vitro diagnostic use.
Quantia PROTEINS standard is intended for use in establishing the calibration curve for the Quantia Al-AT reagents by turbidimetry. For in vitro diagnostic use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050596 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050596: Quantia A1-at.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050596
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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