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 (FDA 510(k) Clearance)

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
314d slower than avg
Panel avg: 104d · This submission: 418d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.