(16 days)
Not Found
No
The summary describes a calibration verification kit for an immunoassay analyzer, which is a standard laboratory control material. There is no mention of AI or ML in the intended use, device description, or any other section.
No
The device is described as a material for quantitative verification of a calibration curve for immunoassay analyzers, indicating it's an in-vitro diagnostic (IVD) reagent used for quality control, not for treating a disease or condition.
No
The device is described as "intended for use in the quantitative verification of the calibration curve established by the Elecsys HCG reagents and calibrators". This indicates it is used to verify the proper functioning of other diagnostic devices (immunoassay analyzers and their reagents/calibrators), rather than directly diagnose a patient's condition. It's a quality control material, not a diagnostic test for a patient.
No
The device description clearly states it is a "three level single analyte set of lyophilized, human based materials," indicating it is a physical reagent kit, not software.
Based on the provided information, the device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "quantitative verification of the calibration curve established by the Elecsys HCG reagents and calibrators on Elecsys 1010 or 2010 immunoassay analyzers." This is a clear diagnostic purpose, as it's used to ensure the accuracy of a test that measures a substance (HCG) in a biological sample.
- Device Description: It describes a "three level single analyte set of lyophilized, human based materials" that are "assayed" and "results are compared to the target values." This aligns with the nature of materials used in IVD testing for quality control and calibration verification.
- Predicate Device: The mention of a predicate device, "K924862 Tosoh Medic AIA-Pack HCG Calibration Verification Test Set," which is also a calibration verification test set, strongly suggests that this type of device is regulated as an IVD.
Therefore, the Elecsys CalCheck HCG fits the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Elecsys CalCheck HCG is intended for use in the quantitative verification of the calibration curve established by the Elecsys HCG reagents and calibrators on Elecsys 1010 or 2010 immunoassay analyzers.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The Elecsys CalCheck HCG 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1660 Quality control material (assayed and unassayed).
(a)
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.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
AUG 300 1996
510(k) Summary
Elecsys® CalCheck™ HCG
| 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 HCG |
| 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 HCG 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 HCG is intended for use in the quantitative verification of the calibration curve established by the Elecsys HCG reagents and calibrators on Elecsys 1010 or 2010 immunoassay analyzers. |
1
510(k) Summary, Elecsys® CalCheck™ HCG, Continued
The Boehringer Mannheim Elecsys CalCheck HCG is substantially 6) Comparison to predicate equivalent to other products in commercial distribution intended for similar device 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 HCG 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.