510(k) · Cleared
ClearedPelicalss Human Igg Subclass Nephlometric Array Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inova Diagnostics, Inc. · DAS Igg (Fc Fragment Specific), Antigen, Antiserum, Control
Cleared on Sep 4, 1998 after an 87-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Sep 4, 1998
- Review
- 87 days
- Class
- Class I
- Product code
- DAS
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK982023 Pelicalss Human Igg Subclass Nephlometric Array KitInova Diagnostics, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK020823 Peliclass Human Igg Subclass Nephelometric Immage KitSanquin Blood Supply Foundation · 2002
Most influential descendants
Showing 1 of 1 · See all- K020823Peliclass Human Igg Subclass Nephelometric Immage KitSanquin Blood Supply Foundation · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K982023 | Pelicalss Human Igg Subclass Nephlometric Array Kit | Inova Diagnostics, Inc. | 1998 | — |
| +1 | K020823 | Peliclass Human Igg Subclass Nephelometric Immage Kit | Sanquin Blood Supply Foundation | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DAS? 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 |
|---|---|---|---|
| K020823 | Peliclass Human Igg Subclass Nephelometric Immage Kit | 2002 | 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?
- Of its descendants, K020823 (Sanquin Blood Supply Foundation, 2002) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DAS devicesDAS Igg (Fc Fragment Specific), Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DAS
FDA has decided no DAS device since 2007.
Median 510(k) review, days · DAS
Too few DAS 510(k)s in any year since 2007 to give a median.
Recalls per year · DAS
No recall names DAS since 2007.
Adverse event reports per year · DAS
No MAUDE report names DAS since 2007.
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 | 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 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The contents of the Peliclass™ subclass nephelometric Array® kit will allow quantitative determination of all four IgG subclasses in at least 25 samples with the Beckman Array ® Protein System. The determination of IgG subclasses is to be used in conjunction with other clinical findings to aid in the assessment of the humoral immune status.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982023 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982023: Pelicalss Human Igg Subclass Nephlometric Array Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982023
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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