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Cytotoxicity Testing (MEM & Agar Overlay)

Cytotoxicity Testing (MEM & Agar Overlay)

The Cytotoxicity/MEM/Agar Overlay is designed to demonstrate the cytotoxic effects of potential leachables from a device/material. The test is performed on all medical devices with patient contact, raw materials and devices undergoing a cleaning validation or residual manufacturing.

The Cytotoxicity/MEM/Agar Overlay meets AAMI/ANSI/ISO 10993-5 requirements as well as USP <87> requirements. Nelson Laboratories can provide results in as little as 4 days for a non-GLP study.

Download the biocompatibility test matrix. [Based on ISO 10993-1:2010 (E) and FDA G95-1 Guidelines]

Applicable Standards

ANSI/AAMI/ISO 10993-5    |    USP <87>    |    ANSI/AAMI/ISO 10993-12

Pricing/Quote

Test Price Request Quote
CTX101 - Cytotoxicity: Agar overlay, L929 cells, 24 hrs. incubation
Per test1+$180.00
Add
CTX110 - Cytotoxicity: MEM elution, 48 hr inc., triplicate L929, 24 hr ext
Per test1+$180.00
Add
CTX115 - Cytotoxicity: MEM elution, 72 hr incub., triplicate L929, 24 hr ext
Per test1+$180.00
Add
CTX125 - Cytotoxicity: MEM elution, L929, titration method, 4 dose levels
Per test1+$325.00
Add
CTX201 - Cytotoxicity (GLP): Agar overlay, L929 cells, 24 hrs. incubation
Per test1+$455.00
Add
CTX210 - Cytotoxicity (GLP): MEM elution, 48 hr inc., triplicate L929, 24 hr ext
Per sample1+$455.00
Add
CTX215 - Cytotoxicity (GLP): MEM elution, 72 hr incub., triplicate L929, 24 hr ext
Per sample1+$455.00
Add
CTX225 - Cytotoxicity (GLP): MEM elution, L929, titration method, 4 dose levels
Per test1+$600.00
Add
CTX701 - Cytotoxicity: MEM elution or Agar overlay, additional reads
Per test1+$50.00
Add
CTX705 - Cytotoxicity: pH read on extract
GeneralFee1+$40.00
Add
CTX101 - Cytotoxicity: Agar overlay, L929 cells, 24 hrs. incubation
Per test1+$180.00
CTX110 - Cytotoxicity: MEM elution, 48 hr inc., triplicate L929, 24 hr ext
Per test1+$180.00
CTX115 - Cytotoxicity: MEM elution, 72 hr incub., triplicate L929, 24 hr ext
Per test1+$180.00
CTX125 - Cytotoxicity: MEM elution, L929, titration method, 4 dose levels
Per test1+$325.00
CTX201 - Cytotoxicity (GLP): Agar overlay, L929 cells, 24 hrs. incubation
Per test1+$455.00
CTX210 - Cytotoxicity (GLP): MEM elution, 48 hr inc., triplicate L929, 24 hr ext
Per sample1+$455.00
CTX215 - Cytotoxicity (GLP): MEM elution, 72 hr incub., triplicate L929, 24 hr ext
Per sample1+$455.00
CTX225 - Cytotoxicity (GLP): MEM elution, L929, titration method, 4 dose levels
Per test1+$600.00
CTX701 - Cytotoxicity: MEM elution or Agar overlay, additional reads
Per test1+$50.00
CTX705 - Cytotoxicity: pH read on extract
GeneralFee1+$40.00

Turn Around Time

Standard turn around times (TAT) are listed below. Ask an expert for a specific consultation on your product.

Code Test TAT
CTX101 Cytotoxicity: Agar overlay, L929 cells, 24 hrs. incubation 7
CTX110 Cytotoxicity: MEM elution, 48 hr inc., triplicate L929, 24 hr ext 7
CTX115 Cytotoxicity: MEM elution, 72 hr incub., triplicate L929, 24 hr ext 10
CTX125 Cytotoxicity: MEM elution, L929, titration method, 4 dose levels 10
Code TAT
CTX101 7
CTX110 7
CTX115 10
CTX125 10

Sample Specifications

CTX101: 400 mm2 or 2 grams; must divide into 3 portions > 100mm or 100mg
CTX110: 1 complete device, each device must be 120 cm2 or 4 grams
CTX115: 1 complete device, each device must be 120 cm2 or 4 grams
CTX125: 1 complete device, each device must be 120 cm2 or 4 grams
CTX201: Turn Around Time is 7 days from PDS approval. 400 mm2 or 2 grams; must divide into 3 portions > 100 mm or 100 mg
CTX210: Turn Around Time is 7 days from PDS approval. 1 complete device, each device must be 120 cm2 or 4 grams
CTX215: Turn Around Time is 10 days from PDS Approval. 1 complete device, each device must be 120 cm2 or 4 grams
CTX225: Turn Around Time is 10 days from PDS Approval. 1 complete device, each device must be 120 cm2 or 4 grams

Study Outline

MEM Elution
Devices/materials are generally extracted in serum-supplemented mammalian cell culture media (MEM), but may be extracted in cell culture media without serum if requested by the sponsor. The devices/materials are extracted for 24 – 25 hours at 37 ± 1ºC generally with agitation. After extraction, the extracts are placed in contact with a monolayer of L-929 cells (mouse fibroblasts).

The cells are incubated at 37 ± 1ºC in 5 ± 1% CO2 for either 48 ± 3 hours or 72 ± 3 hours (or other incubation times as requested by the sponsor). The cells are then scored for cytopathic effect using a scale from 0 – 4 as listed in AAMI/ANSI/ISO 10993-5 and USP <87>. The device/material meets ISO and USP requirements if the cytotoxic response is not greater than grade 2 (mildly reactive).

Agar Overlay
Materials are generally tested by surface area using at least 100 mm2 of material per well. Weight may also be used for liquids, gels or powders using at least 100 mg per well. The material is placed on a layer of agarose that is placed on top of a monolayer of L-929 cells and incubated for 24 – 26 hours at 37 ± 1ºC in 5 ± 1% CO2. After incubation, the zone of cell destruction is measured and scored based on a 0 – 4 scale listed in AAMI/ANSI/ISO 10993-5 and USP <87>. The material meets ISO and USP requirements if the cytotoxic response is not greater than grade 2 (mildly reactive).