(21 days)
Not Found
No
The summary describes a control solution for laboratory assays, not a device that processes data or images using AI/ML.
No
This device is a control for diagnostic assays, which means it is used to verify the performance of tests rather than to treat a condition.
No
Explanation: The device is described as a "Control" for assays, indicating it is used to verify the performance of other diagnostic devices (the Elecsys® CK-MB and Troponin-T assays) rather than directly diagnosing a condition itself.
No
The device description clearly states it is a "Human serum albumin control with CK-MB and Troponin-T," indicating a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is a "Control for Elecsys® CK-MB and Troponin-T assays." Controls are used in laboratory settings to verify the accuracy and precision of diagnostic tests performed on biological samples (in vitro).
- Device Description: The description mentions it is a "Human serum albumin control with CK-MB and Troponin-T for use in CK-MB and Troponin-T assays." This further confirms its use in laboratory testing of biological samples.
- Predicate Devices: The listed predicate devices (Elecsys® CK-MB CalSet and Elecsys® Troponin-T CalSet) are also IVD devices used for calibration in diagnostic assays. This indicates the device in question is part of a system used for in vitro diagnostics.
The information provided clearly aligns with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
N/A
Intended Use / Indications for Use
Control for Elecsys® CK-MB and Troponin-T assays.
Product codes
Not Found
Device Description
Human serum albumin control with CK-MB and Troponin-T for use in CK-MB and Troponin-T assays.
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
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Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the logo for Boehringer Diagnostics. The logo consists of the word "boehringer" inside of a circle, with the word "mannheim" written vertically to the left of the circle. To the right of the logo is the word "Diagnostics" in a serif font.
JUL 22 1996
a region an
510(k) Summary
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
2400 Bisso Lane
Concord, CA 94524-4117
(510) 674-0667 |
|-------------------------------------|------------------------------------------------------------------------------------------------|
| | Contact Person: Patricia Klimley |
| | Date Prepared: June 28, 1996 |
| 2. Device name | Proprietary name: Elecsys® PreciControl Cardiac 1 and 2 |
|---|---|
| Common name: Control material | |
| Classification name: Enzyme controls (Assayed and Unassayed) |
| 3. Predicate device | The Boehringer Mannheim Elecsys® PreciControl Cardiac 1and 2 are
substantially equivalent to the Elecsys® CK-MB and Elecsys® Troponin-T
CalSets (K961501 & K961500). The intended use has been changed to a
quality control material. |
| --------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|
Continued on next page
1
Image /page/1/Picture/0 description: The image shows the logo for Boehringer Diagnostics. The logo consists of the word "mannheim" written vertically on the left side of a black square. Inside the square is a circle with the word "boehringer" written inside it. To the right of the square is the word "Diagnostics".
510(k) Summary, Continued
| 4.
Device
Description | Human serum albumin control with CK-MB and Troponin-T for use in CK-
MB and Troponin-T assays. |
|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 5.
Intended
use | Control for Elecsys® CK-MB and Troponin-T assays. |
| 6.
Comparison
to
predicate
device | The Boehringer Mannheim Elecsys® PreciControl Cardiac 1and 2 are
substantially equivalent to the Elecsys® CK-MB and Elecsys® Troponin-T
CalSets (K961501 & K961500). The intended use has been changed to a
quality control material. |
| | The following table compares the Elecsys® PreciControl Cardiac 1 and 2 with
the predicate device, Elecsys® CK-MB and Elecsys® Troponin-T CalSets
(K961501 & K961500). |
| | Similarities:
•Same matrix: Human serum matrix |
| | • Same analytes: CK-MB and Troponin-T |
| | • Standardization: CK-MB - commercially available CK-MB test, Troponin-T
- highly purified bovine cardiac troponin-T. |
| | •Storage conditions: 2 - 8°C |
| | • Application test system: Elecsys® 2010 |
| | •Reconstitution: 2 mL distilled water |
| | •Manufacturer: Boehringer Mannheim Germany |
| | Continued on next page |
2
Image /page/2/Picture/0 description: The image shows the logo for Boehringer Diagnostics. The logo consists of a black square with a white circle inside, with the word "boehringer" written in white inside the circle. To the left of the circle, the word "mannheim" is written vertically in white. To the right of the logo, the word "Diagnostics" is written in a serif font.
510(k) Summary, Continued
Differences:
- Comparison to predicate device cont.
| Feature | Elecsys® CK-MB and
Troponin-T CalSet | Elecsys ® PreciControl
Cardiac |
|-------------------------|---------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| Target
concentration | CK-MB: 0.15 and 500
ng/mL (approximately)
Troponin-T: 0.021 and 25
ng/mL (approximately) | CK-MB: 6.0 and 60 ng/mL
(approximately)
Troponin-T: 0.2 and 6.0 ng/mL
(approximately) |
| Intended Use | Calibration of the Elecsys
CK-MB and Troponin-T
Assays | Monitoring assays for CK-
MB and Troponin-T |
| Open vial
stability | 2 weeks at 2 - 8°C | 3 days at 2 - 8°C |
Performance Characteristics:
| Feature | Elecsys® CK-MB and
Troponin-T CalSet | Elecsys ® PreciControl
Cardiac |
|------------------------|---------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Open Vial
Stability | 2 weeks at 2 - 8°C | 3 days at 2 - 8°C |
| Value
Assignment | CK-MB: 0.15 and 500
ng/mL (approximately)
Troponin-T: 0.021 and 25
ng/mL (approximately) | CK-MB: 6.0 and 60 ng/mL
(approximately)
Troponin-T: 0.2 and 6.0 ng/mL
(approximately ) |