Who is the manufacturer of ELECSYS CALCHECK T4?

Boehringer Mannheim Corp. filed the 510(k) submission for ELECSYS CALCHECK T4 (K963178).

What is the FDA product code for ELECSYS CALCHECK T4?

JJX. It is classified under 21 CFR 862.1660 as a Class 1 device in the Clinical Chemistry panel.

What is the regulatory pathway for ELECSYS CALCHECK T4?

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

Who can help prepare an FDA 510(k) submission like ELECSYS CALCHECK T4?

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.

ELECSYS CALCHECK T4

K963178 · Boehringer Mannheim Corp. · JJX · Aug 27, 1996 · Clinical Chemistry

Device Facts

Record ID	K963178
Device Name	ELECSYS CALCHECK T4
Applicant	Boehringer Mannheim Corp.
Product Code	JJX · Clinical Chemistry
Decision Date	Aug 27, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1660
Device Class	Class 1

Intended Use

Elecsys CalCheck T4 is intended for use in the quantitative verification of the calibration curve established by the Elecsys T4 reagents and calibrators on Elecsys 1010 or 2010 immunoassay analyzers.

Device Story

Elecsys CalCheck T4 consists of three-level lyophilized, human-based materials; used to verify calibration curves of T4 assays on Elecsys 1010/2010 immunoassay analyzers. User reconstitutes material, performs triplicate assays on the analyzer, and compares results against target values. Provides quality control for automated immunoassay systems; ensures accuracy of patient T4 measurements.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Lyophilized, human-based material; three-level set; single analyte (T4).

Indications for Use

Indicated for use as a calibration verification material for T4 analyte assays on Elecsys 1010 or 2010 immunoassay analyzers.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Predicate Devices

Tosoh Medic AIA-Pack HCG Calibration Verification Test Set (K924862)

Related Devices

K963167 — ELECYS CALCHECK T 3 · Boehringer Mannheim Corp. · Aug 27, 1996
K963164 — ELECSYS CALCHECK FT4 · Boehringer Mannheim Corp. · Aug 27, 1996
K963147 — ELECSYS CALCHECK TSH · Boehringer Mannheim Corp. · Aug 23, 1996
K112528 — ELECSYS T4 CALCHECK 5 · Roche Diagnostics Corporation · Oct 18, 2011
K963163 — ELECSYS CALCHECK FT3 · Boehringer Mannheim Corp. · Aug 27, 1996

Submission Summary (Full Text)

{0} K963178 AUG 27 1996 # 510(k) Summary ## Elecsys® CalCheck™ T4 **Introduction** According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. **1) Submitter name, address, contact** Boehringer Mannheim Corporation 9115 Hague Rd. Indianapolis, IN 46250 (317) 845-2000 Contact Person: John D. Stevens Date Prepared: August 12, 1996 **2) Device name** Proprietary name: Elecsys CalCheck T4 Common name: Calibration Verification Material Classification name: Single (specified) analyte controls (assayed + unassayed) **3) Predicate device** We claim substantial equivalence to the Tosoh Medic AIA-Pack HCG Calibration Verification Test Set, K924862. The intended use for both products is to verify the calibration curve of automated immunoassay analyzers **4) Device Description** The Elecsys CalCheck T4 is a three level single analyte set of lyophilized, human based materials. After reconstitution they are assayed in triplicate and the results are compared to the target values. **5) Intended use** Elecsys CalCheck T4 is intended for use in the quantitative verification of the calibration curve established by the Elecsys T4 reagents and calibrators on Elecsys 1010 or 2010 immunoassay analyzers. 11 {1} 12 # 510(k) Summary, Elecsys® CalCheck™ T4, Continued ## 6) Comparison to predicate device The Boehringer Mannheim Elecsys CalCheck T4 is substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed Tosoh Medics AIA-Pack HCG Calibration Verification Test Set, K924862. The intended use of both the Elecsys CalCheck T4 and the predicate device are the same in that they are intended to be used for the calibration verification for their labeled analytes on automated immunoassay analyzers.