Agena Bioscience, Inc.
4 extracted findings · 2 model-assigned issue types
FDA source excerpt, selected passage
The evidence reveals that the iPLEX HS Colon Panel intended for use with the MA4 is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or…
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
The iPLEX HS Colon Panel intended for use with the MA4 is adulterated because it lacks an approved PMA or IDE application.
Supporting FDA text
Source excerpt · automated text-match checkThe evidence reveals that the iPLEX HS Colon Panel intended for use with the MA4 is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g).
The iPLEX HS Colon Panel is misbranded because the firm did not submit a 510(k) notification before commercial distribution.
Supporting FDA text
Source excerpt · automated text-match checkThe device is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k).
The iPLEX HS Colon Panel is a new device or a significant modification of a cleared device, requiring a 510(k) submission.
Supporting FDA text
Source excerpt · automated text-match checkYou were required to submit to FDA a 510(k) for this device, because it either is a new device (21 CFR 807.81(a)(1)) or, if your iPLEX HS Colon Panel intended for use with the MA4 represents a change or modification from the device cleared in K132978 (which is indicated for use as an aid in diagnosis of patients with suspected thrombophilia), has been significantly changed or modified in design, components, method of manufacture, or intended use (21 CFR 807.81(a)(3)).
The firm failed to submit a written report to FDA for a correction/removal of iPLEX HS Colon v1.0 Panel lots that could cause false negative results.
Supporting FDA text
Source excerpt · automated text-match checkOn June 1, 2021, your firm issued a Customer Notification alerting customers that certain lots of your iPLEX HS Colon v1.0 Panel did not include the A nucleotide termination in Well #8 which your firm determined could result in false negative results for three target variant alleles. Your firm instructed customers to not use the results for the impacted variants and that your firm would reformulate and verify the termination mix and provide further updates on availability. Your firm did not submit a written report of this removal to the agency, as required by 21 CFR 806.10.
Findings extracted from the letter
Selected FDA passages, not the complete letter.
Source passage selected by the model
Source passage selected by the model
Source passage selected by the model
Source passage selected by the model
What FDA requested
Model-assisted summary. Consult the letter for complete requests and conditions.
- Immediately cease any activities that result in the misbranding or adulteration of your devices.
- Take prompt action to address any violations.
- Provide a written response within fifteen business days detailing specific steps taken to address the concerns, including documentation of corrections and/or corrective actions that address systemic problems.
- If corrections cannot be completed within fifteen business days, provide a timetable for implementation and the reason for requiring additional time.
- If you believe your products are not in violation, include your reasoning and supporting information.
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.