510(k) · Cleared
Recalled · Class II · 2022N Antisera to Human Immunoglobulins (Igg, Iga and Igm) and N/T Protein Control LC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics · CFN Method, Nephelometric, Immunoglobulins (G, A, M)
Cleared on Mar 24, 2009 as substantially equivalent to K963974 (Beckman Instruments, Inc., 1997) and 2 other predicates after a 123-day review. Its family tree reaches back 6 generations to 2000. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Mar 24, 2009
- Review
- 123 days
- Class
- Class II
- Product code
- CFN
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 6 generations to K002852 (2000). 22 ancestors in all, the oldest K860894 (1986). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK002852 N/T Protein Control SLDade Behring, Inc. · 2000
- 5 generations backK012468 Modification to N/T Protein Control SLDade Behring, Inc. · 2001
- 4 generations backK061338 Dimension Vista Iga Flex Reagent Cartridge AssayDade Behring, Inc. · 2006
- 3 generations backK062055 Dimension Vista Protein 1 Calibrator, Control Low, Control Medium…Dade Behring, Inc. · 2006
- 2 generations backK063508 Dimension Vista Protein 1 Calibrator and Control L, M, H; Protein 2…Dade Behring, Inc. · 2007
- 1 generation backK072435 Dimension Vista Protein 3 Calibrator, 3 Control,1 Control L, 1…Dade Behring, Inc. · 2007
- This deviceK083445 N Antisera to Human Immunoglobulins (Igg, Iga and Igm) and N/T…Siemens Healthcare Diagnostics · 2009
- Descendant · cites it directly · 0 of its ownK233663 N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)Siemens Healthcare Diagnostics Products GmbH · 2023
Most influential descendants
Showing 1 of 1 · See all- K233663N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)Siemens Healthcare Diagnostics Products GmbH · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K002852 | N/T Protein Control SL | Dade Behring, Inc. | 2000 | — |
| −5 | K012468 | Modification to N/T Protein Control SL | Dade Behring, Inc. | 2001 | — |
| −4 | K061338 | Dimension Vista Iga Flex Reagent Cartridge Assay | Dade Behring, Inc. | 2006 | — |
| −3 | K062055 | Dimension Vista Protein 1 Calibrator, Control Low, Control Medium, Control High | Dade Behring, Inc. | 2006 | — |
| −2 | K063508 | Dimension Vista Protein 1 Calibrator and Control L, M, H; Protein 2 Calibrator… | Dade Behring, Inc. | 2007 | — |
| −1 | K072435 | Dimension Vista Protein 3 Calibrator, 3 Control,1 Control L, 1 Control M, 1… | Dade Behring, Inc. | 2007 | — |
| 0 (this device) | K083445 | N Antisera to Human Immunoglobulins (Igg, Iga and Igm) and N/T Protein Control… | Siemens Healthcare Diagnostics | 2009 | — |
| +1 | K233663 | N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) | Siemens Healthcare Diagnostics Products GmbH | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 CFN? 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 CFN device
- #1 K233663 N Antisera to Human Immunoglobulins (IgG, IgA…score 8.3 · 7 generations · no Class I recall
- #2 Held for the reportin 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 |
|---|---|---|---|
| * | K963974 | Image-Immunochemistry System Urine ImmunoglobulinSummary page 3…parison information: The IMMAGE® Immunochemistry System Urine Immunoglobulin G (IGU) was determined to be substantially equivalent in 510 (k) Premarket Notification k963974 and is the predicate for adding the urine sample matrix to the N Antisera IgG assay. Meth… | 1997 |
| * | K042735 | N Antisera to Human Immunoglobulins (Igg, Iga and Igm)Summary page 3…0.99 The current N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) was determined to be substantially equivalent in 510 (k) Premarket Notification k042735. The operating principle and reagent composition have not changed. For your convenience, the sections with changes have been… | 2005 |
| * | K072435 | Dimension Vista Protein 3 Calibrator, 3 Control,1 Control L, 1 Control M, 1 Control HSummary page 1…of the Legally Marketed Device: Beckman Coulter IMMAGE® Immunochemistry Systems Urine Immunoglobulin G (IGU) k951635. Dimension Vista® Protein 3 Control k072435 4. Device Descriptions: N Antisera to Human Immunoqlobulins (IqG, IqA, and IqM) Proteins contained in hum… | 2007 |
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 |
|---|---|---|---|
| K233663 | N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) | 2023 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 30, 2022 | Class II | Z-0093-2023 | Under Investigation by firm | N Antiserum to Human IgG are not meeting the current High-Dose Hook Effect expectation of up to 648 mg/L for IgGU (urine) and up to 2290 mg/L for IgGC (CSF). |
| Aug 30, 2022 | Class II | Z-0094-2023 | Under Investigation by firm | N Antiserum to Human IgG are not meeting the current High-Dose Hook Effect expectation of up to 648 mg/L for IgGU (urine) and up to 2290 mg/L for IgGC (CSF). |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 9 months on median.
- 2 of the 22 ancestors have a recall of any class.
- Of its descendants, K233663 (Siemens Healthcare Diagnostics Products GmbH, 2023) has gone furthest, with 0 descendants of its own.
How does its category compare?
All CFN devicesCFN Method, Nephelometric, Immunoglobulins (G, A, M): FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · CFN
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · CFN
28in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CFN
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CFN
1in 2024
MAUDE reports naming product code CFN, 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 | 7 | 69 | 0 | 0 |
| 2009 | 4 | 160 | 0 | 0 |
| 2010 | 2 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 4 | 431 | 0 | 0 |
| 2014 | 2 | — | 5 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 0 | — | 2 | 2 |
| 2019 | 6 | 28 | 0 | 8 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 2 | 1 |
| 2023 | 2 | — | 1 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
In vitro diagnostic reagents for the quantitative determination of immunoglobulins (IgG, IgA and IgM) in human serum, heparinized and EDTA plasma, and IgG in human urine and cerebrospinal fluid (CSF) by means of immunonephelometry on the BNTM Systems. Measurement of immunoglobulins aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. N/T Protein Control LC is intended for use as an assayed…
Read the full statement (120 words)
In vitro diagnostic reagents for the quantitative determination of immunoglobulins (IgG, IgA and IgM) in human serum, heparinized and EDTA plasma, and IgG in human urine and cerebrospinal fluid (CSF) by means of immunonephelometry on the BNTM Systems. Measurement of immunoglobulins aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
N/T Protein Control LC is intended for use as an assayed intralaboratory quality control for assessment of precision and analytical bias in immunochemical determination of the proteins IgG in CSF, IgA in CSF, IgM in CSF, IgG in urine, transferrin in urine, albumin in urine and CSF, al-microglobulin in urine and total protein in urine and CSF, using the BNTM Systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083445 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083445: N Antisera to Human Immunoglobulins (Igg, Iga and Igm) and N/T Protein Control LC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083445
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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