Cleared Traditional

K170232 - AFIAS TSH-SP

K170232 is the FDA 510(k) clearance for AFIAS TSH-SP by Boditech Med, Inc.. It is a Class 2 Chemistry device (product code JLW) cleared through the Traditional 510(k) pathway after a 261-day FDA review.

K170232 · Boditech Med, Inc. · Chemistry device
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Oct 2017
Decision
261d
Days
Class 2
Risk

K170232 is an FDA 510(k) clearance for the AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Boditech Med, Inc. (Chuncheon-Si, KR). The FDA issued a Cleared decision on October 13, 2017 after a review of 261 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1690 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Boditech Med, Inc. devices

Submission Details

510(k) Number K170232 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 2017
Decision Date October 13, 2017
Days to Decision 261 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
173d slower than avg
Panel avg: 88d · This submission: 261d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JLW Radioimmunoassay, Thyroid-stimulating Hormone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1690
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 Peers - JLW Radioimmunoassay, Thyroid-stimulating Hormone

All 144
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K170232.
Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP)
K222116 · Siemens Healthcare Diagnostics, Inc. · Jul 2023
Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer
K221225 · Beckman Coulter, Inc. · Nov 2022
Elecsys TSH
K190773 · Roche Diagnostics · Apr 2019
Lumipulse G TSH-III Immunoreaction Cartridges
K171103 · Fujirebio Diagnostics,Inc. · Jul 2017
Elecsys TSH assay, cobas e 801 Immunoassay analyzer
K162606 · Roche Diagnostics · Jan 2017
Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems
K153651 · Beckman Coulter, Inc. · Aug 2016