Cleared Traditional

K221817 - ALFIS Vitamin D, ALFIS-3 Analyzer (FDA 510(k) Clearance)

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

K221817 · Immunostics Inc., · Chemistry device
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Sep 2023
Decision
457d
Days
Class 2
Risk

K221817 is an FDA 510(k) clearance for the ALFIS Vitamin D, ALFIS-3 Analyzer. Classified as System, Test, Vitamin D (product code MRG), Class II - Special Controls.

Submitted by Immunostics Inc., (Eatontown, US). The FDA issued a Cleared decision on September 22, 2023 after a review of 457 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1825 - the FDA in vitro diagnostics and chemistry 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 Chemistry submissions.

View all Immunostics Inc., devices

Submission Details

510(k) Number K221817 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2022
Decision Date September 22, 2023
Days to Decision 457 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
369d slower than avg
Panel avg: 88d · This submission: 457d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MRG System, Test, Vitamin D
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1825
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 Chemistry devices follow this clearance model.

Regulatory Consultant

Boditech Med, Inc.
Parag Bhurchandi

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MRG System, Test, Vitamin D

All 45
Devices cleared under the same product code (MRG) and FDA review panel - the closest regulatory comparables to K221817.
MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer
K232587 · Shenzhen New Industries Biomedical Engineering Co., Ltd. · Apr 2024
Access 25(OH) Vitamin D Total
K223503 · Beckman Coulter, Inc. · Jan 2023
Elecsys Vitamin D total III
K210901 · Roche Diagnostics · Sep 2021
ADVIA Centaur Vitamin D Total (VitD)
K200509 · Siemens Healthcare Diagnostics, Inc. · May 2020