Agena Bioscience, Inc.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

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 an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g).

Passage 2

The 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).

Passage 3

You 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)).

Passage 4

On 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.