Cleared Traditional

K222251 - B·R·A·H·M·S CgA II KRYPTOR, B·R·A·H·M·S CgA II KRYPTOR CAL, B·R·A·H·M·S CgA II KRYPTOR QC

K222251 is an FDA 510(k) clearance for B·R·A·H·M·S CgA II KRYPTOR, manufactured by B.R.A.H.M.S GmbH, Part of Thermo Fisher. The device is a Class 2 Immunology device with product code QXS cleared through the Traditional 510(k) pathway after a 418-day FDA review.

K222251 · B.R.A.H.M.S GmbH, Part of Thermo Fisher · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2023
Decision
418d
Days
Class 2
Risk

K222251 is an FDA 510(k) clearance for the B·R·A·H·M·S CgA II KRYPTOR, B·R·A·H·M·S CgA II KRYPTOR CAL, B·R·A·H·M·S CgA I.... Classified as Chromogranin A (product code QXS), Class II - Special Controls.

Submitted by B.R.A.H.M.S GmbH, Part of Thermo Fisher (Hennigsdorf, DE). The FDA issued a Cleared decision on September 18, 2023 after a review of 418 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.6010 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Immunology submissions.

View all B.R.A.H.M.S GmbH, Part of Thermo Fisher devices

FDA 510(k) Submission Details - K222251

510(k) Number K222251 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2022
Decision Date September 18, 2023
Days to Decision 418 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
313d slower than avg
Panel avg: 105d · This submission: 418d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QXS Device Classification - Class 2, Special Controls

Product Code QXS Chromogranin A
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.6010
Definition In Vitro Test To Measure Chromogranin A (cga) As An Aid In Monitoring During The Course Of Disease And Treatment In Patients With Gastroentero-pancreatic Neuroendocrine Tumors.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.