Cleared Traditional

K151799 - EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000

K151799 is an FDA 510(k) clearance for EliA anti-TG Immunoassay, manufactured by Phadia AB. The device is a Class 2 Immunology device with product code JZO cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K151799 · Phadia AB · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2016
Decision
267d
Days
Class 2
Risk

K151799 is an FDA 510(k) clearance for the EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Co.... Classified as System, Test, Thyroid Autoantibody (product code JZO), Class II - Special Controls.

Submitted by Phadia AB (Uppsala, SE). The FDA issued a Cleared decision on March 25, 2016 after a review of 267 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5870 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Phadia AB devices

FDA 510(k) Submission Details - K151799

510(k) Number K151799 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2015
Decision Date March 25, 2016
Days to Decision 267 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
162d slower than avg
Panel avg: 105d · This submission: 267d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JZO Device Classification - Class 2, Special Controls

Product Code JZO System, Test, Thyroid Autoantibody
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5870
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.

Regulatory Consultant

Phadia US, Inc.
MARTIN ROBERT MANN

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 - JZO System, Test, Thyroid Autoantibody

All 71
Devices cleared under the same product code (JZO) and FDA review panel - the closest regulatory comparables to K151799.
Access Thyroglobulin Antibody II
K213517 · Beckman Coulter, Inc. · Sep 2023
Elecsys Anti-Tg
K222610 · Roche Diagnostics · Sep 2023
Elecsys Anti-TSHR
K193313 · Roche Diagnostics · Feb 2020
IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material
K152061 · Siemens Healthcare Diagnostics, Inc. · Mar 2016
THYRETAIN TM TSI REPORTER BIOASSAY
K092229 · Diagnostic Hybrids, Inc. · May 2010
THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103-120
K090760 · Theratest Laboratories, Inc. · Sep 2009