Who can help prepare an FDA 510(k) submission like FREE TRIIODOTHYRONINE(FT3) ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

FREE TRIIODOTHYRONINE(FT3) ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)

Q: Who is the manufacturer of FREE TRIIODOTHYRONINE(FT3) ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)?

Bayer Corp. filed the 510(k) submission for FREE TRIIODOTHYRONINE(FT3) ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM) (K962355).

Q: What is the FDA product code for FREE TRIIODOTHYRONINE(FT3) ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)?

CDP. It is classified under 21 CFR 862.1710 as a Class 2 device in the Clinical Chemistry panel.

Q: What is the regulatory pathway for FREE TRIIODOTHYRONINE(FT3) ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for FREE TRIIODOTHYRONINE(FT3) ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)?

INCSTAR Clinical Assays™ GammaCoat™ Free T3 RIA kit.

K962355 · Bayer Corp. · CDP · Jul 12, 1996 · Clinical Chemistry

Device Facts

Record ID	K962355
Device Name	FREE TRIIODOTHYRONINE(FT3) ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)
Applicant	Bayer Corp.
Product Code	CDP · Clinical Chemistry
Decision Date	Jul 12, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1710
Device Class	Class 2

Intended Use

This in vitro method is intended to quantitatively measure Free T3 in human serum on a Technicon Immuno-1 system. Measurements of Free T3 are used in the diagnosis and treatment of thyroid diseases.

Device Story

The Immuno 1 Free T3 method is an in vitro diagnostic assay designed for use on the Technicon Immuno-1 system. It measures Free T3 concentrations in human serum samples. The device utilizes specific reagents and calibrators to perform the assay, providing quantitative results that assist clinicians in diagnosing and managing thyroid-related conditions. The system automates the measurement process, allowing for clinical laboratory use. Results are interpreted by healthcare providers to inform clinical decision-making regarding thyroid disease status and therapeutic monitoring.

Clinical Evidence

Bench testing only. Performance compared to predicate device using 103 serum samples. Correlation coefficient (r) = 0.94; regression equation y = 0.95x - 0.08. Precision (between-run) reported at three concentration levels (1.7, 5.4, 12.8 pg/mL) with CVs ranging from 2.7% to 8.2%. Minimum detectable concentration reported as 0.2 pg/mL. Specificity evaluated via cross-reactivity testing against 18 substances, including thyroid hormones and common medications.

Technological Characteristics

In vitro diagnostic immunoassay reagents and calibrators for use on the Technicon Immuno-1 system. Quantitative measurement of Free T3 in human serum. Specificity characterized by low cross-reactivity (<0.1% for most tested substances).

Indications for Use

Indicated for the quantitative measurement of Free T3 in human serum to aid in the diagnosis and treatment of thyroid diseases.

Regulatory Classification

Identification

A total triiodothyronine test system is a device intended to measure the hormone triiodothyronine in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases such as hyperthyroidism.

Predicate Devices

INCSTAR Clinical Assays™ GammaCoat™ Free T3 RIA kit

Related Devices

K994145 — VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 CALIBRATORS · Ortho-Clinical Diagnostics, Inc. · Dec 22, 1999
K991252 — AIA-PACK FT3 ASSAY · Tosoh Medics, Inc. · May 11, 1999
K974027 — AURAFLEX FT3 150 TEST PACK, AURAFLEX FT3 CALIBRATOR PACK · Alfa Biotech (Uk) , Ltd. · Feb 2, 1998
K983439 — ABBOTT ARCHITECT FREE T3 · Abbott Laboratories · Nov 20, 1998
K960913 — ACCESS FREE T3 ASSAY · Bio-Rad Laboratories, Inc. · Mar 29, 1996

Submission Summary (Full Text)

{0} JUL 12 1996 K962355 # SUMMARY OF SAFETY AND EFFECTIVENESS ## Free T3 Method for Bayer Technicon Immuno 1® System Listed below is a comparison of the performance between the Immuno 1 Free T3 method and a similar device that was granted clearance of substantial equivalence (INCSTAR Clinical Assays™ GammaCoat™ Free T3 RIA kit). The information used in the Summary of Safety and Effectiveness was extracted from the Immuno 1 Free T3 method sheet and the Clinical Assays Free T3 Instruction Manual. ## INTENDED USED This *in vitro* method is intended to quantitatively measure Free T3 in human serum on a *Technicon Immuno-1* system. Measurements of Free T3 are used in the diagnosis and treatment of thyroid diseases. | METHOD | Immuno 1 Free T3 | | Clinical Assays (predicate Device) | | | --- | --- | --- | --- | --- | | Part No. | Reagents T01-3662-51 | | CA-1751 | | | | Calibrators T03-3663-01 | | | | | Minimum Detectable Conc. | 0.2 pg/mL | | 0.02 pg/mL | | | Precision (Between-Run) | 1.7 pg/mL | 8.2% | 2.2 pg/mL | 6.9% | | | 5.4 pg/mL | 4.1% | 8.3 pg/mL | 7.1% | | | 12.8 pg/mL | 2.7% | 15.8 pg/mL | 8.4% | | Correlation | y = 0.95x - 0.08 where | | | | | | y = Immuno 1 Free T3 method | | | | | | x = Clinical Assays Free T3 method | | | | | | n = 103 | | | | | | r = 0.94 | | | | | | S_{yx} = 0.71 pg/mL | | | | {1} # SPECIFICITY % Crossreactivity of : | | Immuno 1 Free T3 | Clinical Assays Free T3 | | --- | --- | --- | | Diiodo-L-tyrosine | <0.1 | <0.02 | | 3-Iodo-L-tyrosine | <0.1 | <0.02 | | Methimazole | 0.0 | N/R | | Phenylbutazone | <0.1 | <0.02 | | 6-n-Propyl-2-thyouracil | <0.1 | N/R | | Tetraiodothyro-acetic acid | <0.1 | N/R | | L-Thyroxine (T4) | <0.1 | <0.02 | | D-Thyroxine | <0.1 | <0.02 | | Ibuprofen | 0 | N/R | | Phenobarbital | 0 | N/R | | Phenytoin | 0 | N/R | | Acetaminophen | 0 | N/R | | 3,5 Diiodo-L-Thyronine | <0.1 | <0.02 | | Acetyl Salicylic Acid | <0.1 | N/R | | Heparinic Acid | <0.1 | N/R | | L-3,3’5’Triiodo-Thyronine | 0.34 | N/R | | Triiodothyroacetic acid | 0.37 | N/R | | Fenoprofen | <0.1 | N/R | N/R = Not Reported Gabriel J. Muraca, Jr. Manager Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097 7/3/96