When this applies
Add this line to a bacterial endotoxin test (USP <85>) when you want several devices reported as one pooled result. Pooling is the standard approach where a single device yields too little eluate to assay, or where the endotoxin limit is expressed per procedure rather than per device.
When to use it
Decide before the samples ship, because pooling changes the extraction and the limit calculation — it is not something that can be applied to a completed test. Confirm the pooled device count with us at quotation so the applicable limit is set correctly from the start.
What the pooled result gives you
A single endotoxin value assessed against the limit applicable to the pooled device count, per USP <85>. That last clause is the whole point: the limit scales with the number of devices pooled, so a pooled result is only meaningful alongside the count it was calculated for.
What it does not give you
It gives no per-device value. If one device in the pool carries the entire endotoxin burden, a pooled result can pass while that individual unit would not — which is why pooling is a sampling decision with consequences, and why some submissions require individual testing.
Method
Testing per USP <85> by Limulus amebocyte lysate. Eluates from the pooled devices are combined and assayed as one sample, with a positive product control run to demonstrate absence of interference, and the result assessed against the limit for the pooled count.
Where it runs
This method is domestically sourced. The laboratory is ISO/IEC 17025 accredited and GLP certified, and the report is issued under Groenakker cover, in Groenakker’s report template or in your document template on request at no extra cost.
Ordered with
The bacterial endotoxin test itself (GRK-7003), which this surcharge accompanies. Material-mediated pyrogenicity is the companion pyrogen endpoint where pyrogenicity is in scope.
