510(k) · Cleared
ClearedVitros Chemistry Products Aat Reagent, Calibrator Kit 99 and Aat Performance Verifiers I, II and Iii
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho-Clinical Diagnostics, Inc. · DEM Alpha-1-Antitrypsin, Antigen, Antiserum, Control
Cleared on Dec 23, 2005 as substantially equivalent to K964766 (Beckman Instruments, Inc., 1997) and 2 other predicates after an 80-day review. Its family tree reaches back 3 generations to 1990. 3 later devices descend from it.
- Decided
- Dec 23, 2005
- Review
- 80 days
- Class
- Class II
- Product code
- DEM
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K904768 (1990). 12 ancestors in all, the oldest K771603 (1977). 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK904768 Kodatrol I and II Control and Diluent SetEastman Kodak Company · 1990 · Recalled
- 2 generations backK041720 Vitros Chemistry Products DLDL Reagent, Calibrator Kit 19, FS…Ortho-Clinical Diagnostics, Inc. · 2004 · Recalled
- 1 generation backK042477 Vitros Chemistry Products Trfrn Reahent; Vitros Chemistry Products…Ortho-Clinical Diagnostics, Inc. · 2004
- This deviceK052819 Vitros Chemistry Products Aat Reagent, Calibrator Kit 99 and Aat…Ortho-Clinical Diagnostics, Inc. · 2005
- Descendant · cites it directly · 1 of its ownK061588 Vitros Chemistry Products Hcy Reagent, Vitros Chemistry Products…Ortho-Clinical Diagnostics, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 0 of its ownK123930 Vitros Chemistry Products Hcy 2 Reagent, Calibrator Kit 27, Hcy 2…Ortho-Clinical Diagnostics, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK060940 Vitros Chemistry Products Calibrator Kit 99, Vitros Chemistry…Ortho-Clinical Diagnostics, Inc. · 2006
Most influential descendants
Showing 3 of 3 · See all- K061588Vitros Chemistry Products Hcy Reagent, Vitros Chemistry Products Calibrator Kit 27, Hcy…Ortho-Clinical Diagnostics, Inc. · 2006 · cites it directly1descendant
- K123930Vitros Chemistry Products Hcy 2 Reagent, Calibrator Kit 27, Hcy 2 Performance Verifiers…Ortho-Clinical Diagnostics, Inc. · 2013 · 2 generations on0descendants
- K060940Vitros Chemistry Products Calibrator Kit 99, Vitros Chemistry Products Aat/HPT…Ortho-Clinical Diagnostics, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K904768 | Kodatrol I and II Control and Diluent Set | Eastman Kodak Company | 1990 | 1 |
| −2 | K041720 | Vitros Chemistry Products DLDL Reagent, Calibrator Kit 19, FS Calibrator 1 and… | Ortho-Clinical Diagnostics, Inc. | 2004 | 1 |
| −1 | K042477 | Vitros Chemistry Products Trfrn Reahent; Vitros Chemistry Products Calibrator… | Ortho-Clinical Diagnostics, Inc. | 2004 | — |
| 0 (this device) | K052819 | Vitros Chemistry Products Aat Reagent, Calibrator Kit 99 and Aat Performance… | Ortho-Clinical Diagnostics, Inc. | 2005 | — |
| +1 | K061588 | Vitros Chemistry Products Hcy Reagent, Vitros Chemistry Products Calibrator… | Ortho-Clinical Diagnostics, Inc. | 2006 | 1 |
| +2 | K123930 | Vitros Chemistry Products Hcy 2 Reagent, Calibrator Kit 27, Hcy 2 Performance… | Ortho-Clinical Diagnostics, Inc. | 2013 | — |
| +1 | K060940 | Vitros Chemistry Products Calibrator Kit 99, Vitros Chemistry Products Aat/HPT… | Ortho-Clinical Diagnostics, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 1 | 0 |
| 1978 | 1 | 0 |
| 1979 | 2 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2013 | 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 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? (3)
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 |
|---|---|---|---|
| * | K964766 | Immage Immunochemistry System Alpha-1-Antitrypsin (Aat)Summary page 3…TROS Chemistry to Products Calibrator Kit 99 are substantially equivalent to the IMMAGE predicate Immunochemistry Systems AAT Reagent (K964766) and Calibrator 2 devices: (K973932) (predicate devices) which were cleared by the FDA for IVD… | 1997 |
| * | K973932 | Beckman Calibrator 2 (CAL2)Summary page 3…ibrator Kit 99 are substantially equivalent to the IMMAGE predicate Immunochemistry Systems AAT Reagent (K964766) and Calibrator 2 devices: (K973932) (predicate devices) which were cleared by the FDA for IVD use. Passing & Bablock… | 1997 |
| * | K042477 | Vitros Chemistry Products Trfrn Reahent; Vitros Chemistry Products Calibrator Kit 20…Summary page 3…ers I, II & III are substantially equivalent to the VITROS Chemistry Products Protein Performance Verifiers I, II& III (K042477) (predicate device) which was cleared by the FDA for IVD use.… | 2004 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 15 years and passes through 2 companies; a new generation was cleared every 1.1 years on median.
- 2 of the 12 ancestors have a recall of any class.
- Of its descendants, K061588 (Ortho-Clinical Diagnostics, Inc., 2006) has gone furthest, with 1 descendant of its own.
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?
For in vitro diagnostic use only. VITROS Chemistry Products AAT Reagent is used to quantitatively measure alpha-1-antitrypsin concentration in human serum. The measurement of alpha-1-antitrypsin in serum aids in the diagnosis of cirrhosis of the liver and pulmonary emphysema.
For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 99 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of alpha-1-antitrypsin (AAT).
For in vitro diagnostic use only. VITROS Chemistry Products AAT Performance Verifiers are assayed controls used to monitor performance of VITROS AAT Reagents on VITROS 5,1 FS Chemistry Systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052819 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052819: Vitros Chemistry Products Aat Reagent, Calibrator Kit 99 and Aat Performance Verifiers I, II and Iii.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052819
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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