Who is the manufacturer of ELECSYS CALCHECK CK-MB?

Boehringer Mannheim Corp. filed the 510(k) submission for ELECSYS CALCHECK CK-MB (K963182).

What is the FDA product code for ELECSYS CALCHECK CK-MB?

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 CK-MB?

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

Who can help prepare an FDA 510(k) submission like ELECSYS CALCHECK CK-MB?

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 CK-MB

K963182 · Boehringer Mannheim Corp. · JJX · Aug 23, 1996 · Clinical Chemistry

Device Facts

Record ID	K963182
Device Name	ELECSYS CALCHECK CK-MB
Applicant	Boehringer Mannheim Corp.
Product Code	JJX · Clinical Chemistry
Decision Date	Aug 23, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1660
Device Class	Class 1

Intended Use

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

Device Story

Elecsys CalCheck CK-MB consists of three-level lyophilized, human-based materials; used for calibration verification of CK-MB assays on Elecsys 1010/2010 immunoassay analyzers. User reconstitutes material, performs triplicate assay, and compares results against target values to verify calibration curve integrity. Used in clinical laboratory settings by laboratory personnel. Provides quality control verification to ensure accurate patient test results.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Three-level lyophilized human-based material; single analyte (CK-MB) control; intended for use on Elecsys 1010/2010 immunoassay analyzers.

Indications for Use

Indicated for quantitative verification of calibration curves for CK-MB 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

K133284 — ELECSYS CK-MB CALCHECK 5 · Roche Diagnostics · Nov 22, 2013
K093582 — ELECSYS CK-MB CALCHECK 5 · Roche Diagnostics · Mar 29, 2010
K963143 — ELECSYS CALCHECK TROPONIN T · Boehringer Mannheim Corp. · Aug 23, 1996
K983492 — BOEHRINGER MANNHEIM ELECSYS PRESICONTROL CARDIAC · Boehringer Mannheim Corp. · Oct 9, 1998
K062152 — CREATININE KINASE MB ISOENZYME VERIFIER, MODEL DC27 · Dade Behring, Inc. · Aug 16, 2006

Submission Summary (Full Text)

{0} K963182 AUG 23 1996 # 510(k) Summary ## Elecsys® CalCheck™ CK-MB ### 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 CK-MB 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 CK-MB 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 CK-MB is intended for use in the quantitative verification of the calibration curve established by the Elecsys CK-MB reagents and calibrators on Elecsys 1010 or 2010 immunoassay analyzers. 11 {1} 12 # 510(k) Summary, Elecsys® CalCheck™ CK-MB, Continued ## 6) Comparison to predicate device The Boehringer Mannheim Elecsys CalCheck CK-MB 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 CK-MB 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.