510(k) · Cleared
ClearedRaichem Prealbumin Spia
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hemagen Diagnostics, Inc. · DDS Prealbumin, Fitc, Antigen, Antiserum, Control
Cleared on Aug 28, 1997 as substantially equivalent to K884297 (Atlantic Antibodies, 1988) after a 31-day review. Its family tree reaches back 1 generation to 1988.
- Decided
- Aug 28, 1997
- Review
- 31 days
- Class
- Class I
- Product code
- DDS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K884297 (1988). No later device cites it as a predicate yet.
- Root · 1 generation backK884297 SPQ (TM) Test System for PrealbuminAtlantic Antibodies · 1988
- This deviceK972812 Raichem Prealbumin SpiaHemagen Diagnostics, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K884297 | SPQ (TM) Test System for Prealbumin | Atlantic Antibodies | 1988 | — |
| 0 (this device) | K972812 | Raichem Prealbumin Spia | Hemagen Diagnostics, Inc. | 1997 | — |
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 DDS? 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 |
|---|---|---|---|
| * | K884297 | SPQ (TM) Test System for PrealbuminSummary page 1…ommon Name: Prealbumin Classification Name: System, Test, immunological, prealbumin Predicate Device Incstar Antibody Reagent Set Il for Prealbumin {510 (k) Docket No. K 884297} Methods Manual method: Described in immunoturbidimetry of transthyretin (prealbumin) in human sera. Clin. Chem: 33: 7, 1260 198… | 1988 |
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 DDS devicesDDS Prealbumin, Fitc, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DDS
FDA has decided no DDS device since 2007.
Median 510(k) review, days · DDS
Too few DDS 510(k)s in any year since 2007 to give a median.
Recalls per year · DDS
No recall names DDS since 2007.
Adverse event reports per year · DDS
No MAUDE report names DDS 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 use of these reagents is indicated for the measurement of prealbumin levels in
human serum or plasma.
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/K972812 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972812: Raichem Prealbumin Spia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972812
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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