Page last updated: October 4, 2003
Q: Does the analyte specific reagent (ASR) disclaimer
requirement apply to the use of all in-house developed tests?
A: No. As long as the laboratory is not using a product
purchased from a manufacturer that is labeled as an ASR and all activities
in support of production of the active ingredients of the in-house test
occur within the four walls of the lab, the ASR disclaimer statement is
not required on the resulting test report.
Q: Are laboratories required to issue disclaimers
on test reports when a test is being used by a laboratory for a non-FDA
A: No. The ASR disclaimer statement is intended to
cover "home brews" built from ASRs. It is not intended to be used to cover
"off-label" uses of FDA cleared or approved products (e.g., use of an
FDA cleared or approved product for a use other than that designated on
Q: Is the disclaimer language required on test reports
if a laboratory modifies an ASR assay?
A: Yes. The disclaimer statement is required in all
instances when an ASR is used by a laboratory.
Q: Is a disclaimer statement necessary when using
an assay purchased from a manufacturer labeled as an immunohistochemistry
A: No. Assays purchased from manufacturers under the
IHC label do not require a disclaimer statement when used by laboratories.
The disclaimer statement only applies to ASRs.
Q: Is a disclaimer statement required when ASRs
are used in non-clinical laboratory settings for purposes other than providing
diagnostic information to patients and practitioners (e.g., forensic,
academic, research settings)?
A: No. The ASR rule does not apply to reagents sold
to and used in non-clinical settings.
Q: Is a disclaimer statement necessary when an ASR
assay that is FDA approved or cleared as part of a test kit is used independently
by a laboratory?
A: Yes. A disclaimer statement must be appended to
the test report when an ASR is used independently of the FDA approved
or cleared test kit.
Q: Where can I obtain additional information on
the FDA ASR and IHC final rules?
A: Additional information is available in information
packet DGP 110, Analyte Specific Reagents, and in information packet DGP
117, Immunohistochemistry (IHC) Reagents. Order