ISAC Regulatory Compliance 5

Question 1

Which regulatory pathway would a manufacturer typically use to bring a novel flow cytometry reagent to the US market if no predicate device exists?

Accepted Answer

De Novo Classification Request

Answer

When no predicate exists for a 510(k) and the device is not high-risk, the De Novo pathway allows FDA to establish a new regulatory classification for the novel device.

Question 2

A laboratory's flow cytometry QC data shows a Levey-Jennings chart with 10 consecutive points on one side of the mean. By Westgard rules, which rule is violated?

Accepted Answer

10x rule — indicating systematic bias or drift

Answer

The 10x Westgard rule is violated when 10 consecutive QC results fall on the same side of the mean, signaling systematic bias or instrument drift requiring investigation.

Question 3

Under GCP (ICH E6 R2), when flow cytometry is used as a biomarker assay in a clinical trial, the assay must be conducted in a laboratory that:

Accepted Answer

Is CAP-accredited or meets equivalent quality standards, and follows the trial protocol

Answer

ICH E6 R2 requires clinical trial laboratories to operate under quality systems equivalent to recognized accreditation standards and to follow the validated protocol specified in the clinical trial agreement.

Question 4

A hospital flow cytometry laboratory receives an unannounced CAP inspection. The inspector finds that competency assessments for one technologist were not completed in the past year. What is the likely consequence?

Accepted Answer

A Phase II deficiency requiring a written corrective action plan

Answer

Failure to complete annual competency assessments is a Phase II deficiency under CAP, requiring the laboratory to submit a corrective action plan within 60 days to maintain accreditation.

Question 5

Which cytometric parameter is most commonly included in a GMP cell therapy lot release panel to confirm the absence of residual undifferentiated pluripotent stem cells?

Accepted Answer

OCT4 or TRA-1-60 as pluripotency markers

Answer

OCT4 and TRA-1-60 are established pluripotency markers; their absence by flow cytometry in a differentiated cell therapy product confirms removal of tumorigenic undifferentiated cells.

(ISAC) International Society for the Advancement of Cytometry Practice Test

(ISAC) International Society for the Advancement of Cytometry Practice Test

ISAC Regulatory Compliance 5