510(k) · Cleared
ClearedRandox Bilirubin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Randox Laboratories, Ltd. · GIG Hemoglobinometer
Cleared on Dec 8, 1997 after a 48-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Dec 8, 1997
- Review
- 48 days
- Class
- Class II
- Product code
- GIG
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK973995 Randox BilirubinRandox Laboratories, Ltd. · 1997
- Descendant · cites it directly · 0 of its ownK111143 Poly-Chem 90 Total BilirubinPolymedco, Inc. · 2011
Most influential descendants
Showing 1 of 1 · See all- K111143Poly-Chem 90 Total BilirubinPolymedco, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973995 | Randox Bilirubin | Randox Laboratories, Ltd. | 1997 | — |
| +1 | K111143 | Poly-Chem 90 Total Bilirubin | Polymedco, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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 GIG? 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 |
|---|---|---|---|
| K111143 | Poly-Chem 90 Total Bilirubin | 2011 | 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, K111143 (Polymedco, Inc., 2011) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GIG devicesGIG Hemoglobinometer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GIG
FDA has decided no GIG device since 2007.
Median 510(k) review, days · GIG
Too few GIG 510(k)s in any year since 2007 to give a median.
Recalls per year · GIG
No recall names GIG since 2007.
Adverse event reports per year · GIG
1in 2021
MAUDE reports naming product code GIG, 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 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 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 | 1 |
| 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 Randox Laboratories Limited Bilirubin Test Kit is an in vitro diagnostic reagent for the quantitative determination of total and direct bilirubin in human serum and plasma. This method uses diazotized sulphanilic acid to measure bilirubin. To measure total bilirubin the sample is first incubated with caffeine which releases bilirubin from albumin. Direct (conjugate) bilirubin is determined in the absence of caffeine. Measurements of bilirubin are used in the diagnosis of liver disease, in the detection of haemolytic anaemia and to evaluate jaundice.
This test kit must be used by suitably qualified laboratory personnel under appropriate laboratory conditions.
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/K973995 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973995: Randox Bilirubin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973995
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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