Who is the manufacturer of ELECSYS CALCHECK T UPDATE?

Boehringer Mannheim Corp. filed the 510(k) submission for ELECSYS CALCHECK T UPDATE (K963181).

What is the FDA product code for ELECSYS CALCHECK T UPDATE?

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 T UPDATE?

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

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

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 T UPDATE

K963181 · Boehringer Mannheim Corp. · JJX · Sep 10, 1996 · Clinical Chemistry

Device Facts

Record ID	K963181
Device Name	ELECSYS CALCHECK T UPDATE
Applicant	Boehringer Mannheim Corp.
Product Code	JJX · Clinical Chemistry
Decision Date	Sep 10, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1660
Device Class	Class 1

Intended Use

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

Device Story

Elecsys CalCheck T Uptake; three-level single-analyte set; lyophilized human-based material. Used for calibration verification of Elecsys T Uptake reagents/calibrators on Elecsys 1010/2010 immunoassay analyzers. User reconstitutes material; assays in triplicate; compares results to target values. Verifies calibration curve accuracy on automated immunoassay systems; supports clinical decision-making by ensuring analytical performance of T Uptake testing.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Three-level lyophilized human-based material; single analyte set; designed for use on Elecsys 1010/2010 immunoassay analyzers.

Indications for Use

Indicated for quantitative verification of calibration curves for T Uptake 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

K963147 — ELECSYS CALCHECK TSH · Boehringer Mannheim Corp. · Aug 23, 1996
K963167 — ELECYS CALCHECK T 3 · Boehringer Mannheim Corp. · Aug 27, 1996
K963178 — ELECSYS CALCHECK T4 · Boehringer Mannheim Corp. · Aug 27, 1996
K963163 — ELECSYS CALCHECK FT3 · Boehringer Mannheim Corp. · Aug 27, 1996
K112528 — ELECSYS T4 CALCHECK 5 · Roche Diagnostics Corporation · Oct 18, 2011

Submission Summary (Full Text)

{0} SEP 10 1996 K963181 # 510(k) Summary ## Elecsys® CalCheck™ T Uptake | 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 T Uptake 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 T Uptake 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 T Uptake is intended for use in the quantitative verification of the calibration curve established by the Elecsys T Uptake reagents and calibrators on Elecsys 1010 or 2010 immunoassay analyzers. | {1} K963181 # 510(k) Summary, Elecsys® CalCheck™ T Uptake, Continued ## 6) Comparison to predicate device The Boehringer Mannheim Elecsys CalCheck T Uptake 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 T Uptake 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. 12