510(k) · Cleared
ClearedPeliclass Human Igg Subclass Nephelometric Immage Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sanquin Blood Supply Foundation · DFZ Igg (Gamma Chain Specific), Antigen, Antiserum, Control
Cleared on May 14, 2002 as substantially equivalent to K982023 (Inova Diagnostics, Inc., 1998) after a 61-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- May 14, 2002
- Review
- 61 days
- Class
- Class II
- Product code
- DFZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K982023 (1998). No later device cites it as a predicate yet.
- Root · 1 generation backK982023 Pelicalss Human Igg Subclass Nephlometric Array KitInova Diagnostics, Inc. · 1998
- This deviceK020823 Peliclass Human Igg Subclass Nephelometric Immage KitSanquin Blood Supply Foundation · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K982023 | Pelicalss Human Igg Subclass Nephlometric Array Kit | Inova Diagnostics, Inc. | 1998 | — |
| 0 (this device) | K020823 | Peliclass Human Igg Subclass Nephelometric Immage Kit | Sanquin Blood Supply Foundation | 2002 | — |
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 DFZ? 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 |
|---|---|---|---|
| * | K982023 | Pelicalss Human Igg Subclass Nephlometric Array KitSummary page 1…02 Name of the Device: Peliclass™ Human IgG Subclass Nephelometric IMMAGE® Kit Predicate Device Information: Peliclass™ Human IgG Subclass Nephelometric Array® Kit, K#982023, Inova Diagnostics, Inc. Device Description: Sheep antibodies to human 1gG subclasses will react with the four subclasses of hu… | 1998 |
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.
How does its category compare?
All DFZ devicesDFZ Igg (Gamma Chain Specific), Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DFZ
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · DFZ
Too few DFZ 510(k)s in any year since 2007 to give a median.
Recalls per year · DFZ
No recall names DFZ since 2007.
Adverse event reports per year · DFZ
No MAUDE report names DFZ 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 | 1 | — | 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™ Human IgG Subclass Nephelometric IMMAGE® Kit will allow quantitative determination of all four IgG Subclasses in at least 50 serum samples with the Beckman IMMAGE Immunochemistry 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 summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020823 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020823: Peliclass Human Igg Subclass Nephelometric Immage Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020823
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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