510(k) · Cleared
ClearedN Antiserum to Human Albumin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Behring Diagnostics, Inc. · DCF Albumin, Antigen, Antiserum, Control
Cleared on Oct 20, 1997 as substantially equivalent to K895883 (Beckman Instruments, Inc., 1989) after a 73-day review. Its family tree reaches back 1 generation to 1989. 5 later devices descend from it.
- Decided
- Oct 20, 1997
- Review
- 73 days
- Class
- Class II
- Product code
- DCF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K895883 (1989). 5 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK895883 Beckman MA Microalbumin Reagent KitBeckman Instruments, Inc. · 1989
- This deviceK972929 N Antiserum to Human AlbuminBehring Diagnostics, Inc. · 1997
- Descendant · cites it directly · 1 of its ownK101203 Tina-Quant Albumin Gen 2Roche Diagnostics · 2010 · Recalled
- Descendant · cites it directly · 0 of its ownK153560 Optilite Low Level Albumin KitThe Binding Site Group, Ltd. · 2016
- Descendant · 2 generations on · 0 of its ownK113072 Tina-Quant Albumin Gen.2Roche Diagnostics Operations · 2012
- Descendant · cites it directly · 0 of its ownK042643 Vitros Chemistry Product Malb Reagent, Calibrator Kit 24, Malb…Ortho-Clinical Diagnostics, Inc. · 2004 · Recalled
- Descendant · cites it directly · 0 of its ownK033525 Dimension Microalbumin (Malb) Flex Reagent Cartridge Method…Dade Behring, Inc. · 2004
Most influential descendants
Showing 5 of 5 · See all- K101203Tina-Quant Albumin Gen 2Roche Diagnostics · 2010 · cites it directly1descendant
- K153560Optilite Low Level Albumin KitThe Binding Site Group, Ltd. · 2016 · cites it directly0descendants
- K113072Tina-Quant Albumin Gen.2Roche Diagnostics Operations · 2012 · 2 generations on0descendants
- K042643Vitros Chemistry Product Malb Reagent, Calibrator Kit 24, Malb Performance Verifiers I…Ortho-Clinical Diagnostics, Inc. · 2004 · cites it directly0descendants
- K033525Dimension Microalbumin (Malb) Flex Reagent Cartridge Method, Calibrator, Models DF114…Dade Behring, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K895883 | Beckman MA Microalbumin Reagent Kit | Beckman Instruments, Inc. | 1989 | — |
| 0 (this device) | K972929 | N Antiserum to Human Albumin | Behring Diagnostics, Inc. | 1997 | — |
| +1 | K101203 | Tina-Quant Albumin Gen 2 | Roche Diagnostics | 2010 | 1 |
| +1 | K153560 | Optilite Low Level Albumin Kit | The Binding Site Group, Ltd. | 2016 | — |
| +2 | K113072 | Tina-Quant Albumin Gen.2 | Roche Diagnostics Operations | 2012 | — |
| +1 | K042643 | Vitros Chemistry Product Malb Reagent, Calibrator Kit 24, Malb Performance… | Ortho-Clinical Diagnostics, Inc. | 2004 | 1 |
| +1 | K033525 | Dimension Microalbumin (Malb) Flex Reagent Cartridge Method, Calibrator… | Dade Behring, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2016 | 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 DCF? 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 |
|---|---|---|---|
| * | K895883 | Beckman MA Microalbumin Reagent KitSummary page 1…Albumin FDA has classified N Antiserum to Human Albumin into Class |l (866.5040). 3. Identification of the legally marketed device: Beckman micro Albumin(MA) Reagent -K895883 4. Proposed Device Description: The proposed product, N Antiserum to Human Albumin is an in vitro diagnostic reagent intended t… | 1989 |
What descends from it? (5)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101203 | Tina-Quant Albumin Gen 2 | 2010 | 1 |
| K153560 | Optilite Low Level Albumin Kit | 2016 | 0 |
| K042643 | Vitros Chemistry Product Malb Reagent, Calibrator Kit 24, Malb Performance Verifiers I… | 2004 | 0 |
| K033525 | Dimension Microalbumin (Malb) Flex Reagent Cartridge Method, Calibrator, Models DF114… | 2004 | 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?
How does its category compare?
All DCF devicesDCF Albumin, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DCF
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · DCF
167in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DCF
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DCF
12in 2025
MAUDE reports naming product code DCF, 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 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 3 | 167 | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 1 | 6 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 0 | — | 0 | 9 |
| 2025 | 0 | — | 0 | 12 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
N Antiserum to Human Albumin is an in vitro diagnostic reagent intended to be used together with the Behring Nephelometer Systems in the measurement of albumin in human serum, cerebrospinal fluid and urine, used as an aid in the diagnosis of kidney and intestinal diseases.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972929 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972929: N Antiserum to Human Albumin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972929
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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