When this test applies
Pooling is the USP <85> approach for small or low-surface-area devices that cannot individually provide enough eluate, and for lot-release schemes where one result is wanted across several units. This fee covers the extra preparation and the pooled-limit calculation for each pooled result; it is not a standalone test.
When to run it
At the time the bacterial endotoxin test (GRK-7003-01) is ordered, once you know how many devices will go into each result. If each device is tested individually, leave it off the quote.
What a pass tells you
A single endotoxin result for the pooled devices, assessed against the endotoxin limit applicable to the pooled device count — the per-device limit divided by the number of devices pooled — so pooling never lowers the sensitivity below what each device would need on its own.
What it does not tell you
Nothing on its own. It adds to the LAL test rather than replacing it, and it does not change what the LAL test can or cannot detect.
Method
Applies where several devices are pooled into one determination per USP <85>. The devices are eluted together, the pooled eluate is tested by the kinetic turbidimetric LAL method and the result is read against the pooled endotoxin limit. Priced per pooled result.
Where it runs
This method is domestically sourced (US). The laboratory is ISO/IEC 17025 accredited and GLP certified, and the report is issued under Groenakker’s ISO 13485:2016 certified quality system, in Groenakker’s report template or in your document template on request at no extra cost.
Usually ordered alongside
The bacterial endotoxin test (GRK-7003-01) it attaches to, and material-mediated pyrogenicity where that endpoint is also open.
