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

510(k) Premarket Notification

Answer

Premarket Approval (PMA) Application

Answer

Humanitarian Device Exemption (HDE)

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

1-2s warning rule

Answer

R-4s rule — indicating random error

Answer

2-2s rule — indicating reagent lot shift

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

Is owned and operated by the sponsor company

Answer

Has published the assay method in a peer-reviewed journal

Answer

Is located in the same country as the clinical trial sites

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

Immediate suspension of CLIA certificate

Answer

A recommendation with no required follow-up

Answer

Automatic referral to the state medical board

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

CD45 expression to confirm hematopoietic lineage

Answer

CD3 to confirm T-cell identity

Answer

HLA-DR to assess antigen presentation capacity

Question 6

Under 21 CFR Part 11, which technical control is required for electronic flow cytometry data files that serve as records in FDA-regulated studies?

Accepted Answer

Audit trails that record creation, modification, and deletion of records with timestamp and user ID

Answer

Printed paper backup of all digital records

Answer

Encryption of all data with AES-256 only

Answer

Storage exclusively on FDA-managed servers

Question 7

A clinical flow cytometry laboratory plans to extend its CD4 assay to a pediatric population not covered by the original validation. Which CLIA/CAP requirement applies?

Accepted Answer

A full re-validation as if the assay were a new LDT, including a pediatric reference range

Answer

No additional action needed if the same reagents and instrument are used

Answer

A waiver request submitted to CMS before testing begins

Answer

An updated proficiency testing enrollment in a pediatric sub-specialty