(21 days)
Not Found
No
The summary describes a control material for a TSH assay, which is a chemical reagent, not a software or hardware device that would typically incorporate AI/ML. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
No.
This device is described as a "Control for Thyroid Stimulating Hormone assays" and a "Horse serum albumin control with recombinant Thyroid Stimulating Hormone for use in TSH assays," indicating it is used for calibration or quality control of diagnostic tests, not for treating a condition.
No
This device is described as a "Control for Thyroid Stimulating Hormone assays," meaning it is used to verify the accuracy of diagnostic assays, not to perform a diagnosis itself.
No
The device description clearly states it is a "Horse serum albumin control with recombinant Thyroid Stimulating Hormone," indicating a physical, biological product, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is explicitly stated as a "Control for Thyroid Stimulating Hormone assays." This indicates the device is used in vitro (outside the body) to evaluate the performance of diagnostic tests.
- Device Description: The description confirms it's a "Horse serum albumin control with recombinant Thyroid Stimulating Hormone for use in TSH assays." This further clarifies its role as a reagent used in laboratory testing.
- Predicate Device: The mention of a predicate device (K961491; Elecsys® TSH CalSet) which is also a control for TSH assays, strongly suggests that this device falls under the same regulatory category, which for such controls is IVD.
IVD devices are used to examine specimens from the human body, such as blood, urine, or tissue, to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. A control used in such assays fits this definition.
N/A
Intended Use / Indications for Use
Control for Thyroid Stimulating Hormone assays.
Product codes
Not Found
Device Description
Horse serum albumin control with recombinant Thyroid Stimulating Hormone for use in TSH 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
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
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
JUL 22 1996
Image /page/0/Picture/2 description: The image shows the logo for Boehringer Diagnostics. The logo consists of the word "boehringer" inside of a circle, which is inside of a black square. To the right of the square is the word "Diagnostics" in a serif font.
510(k) Summary
According to the requirements of 21 CFR 807.92, the following information Introduction provides sufficient detail to understand the basis for a determination of substantial equivalence. Boehringer Mannheim Corporation 1. Submitter 2400 Bisso Lane n a me, Concord, CA 94524-4117 address, (510) 674-0667 contact Contact Person: Patricia Klimley Date Prepared: June 26, 1996 2. Proprietary name: Elecsys® PreciControl TSH Assay Device name Common name: Control material Classification name: Enzyme controls (Assayed and Unassayed) 3. The Boehringer Mannheim Elecsys® PreciControl TSH is substantially Predicate equivalent to the Elecsys® TSH CalSet (K961491). The intended use has device 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 words "mannheim" and "boehringer" stacked on top of each other inside of a black square with a white circle. To the right of the logo is the word "Diagnostics" in a serif font.
510(k) Summary, Continued
ﺍﻟﻤﺴﺎﻋﺪ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ
| 4.
Device
Description | Horse serum albumin control with recombinant Thyroid Stimulating Hormone
for use in TSH assays. | |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 5.
Intended use | Control for Thyroid Stimulating Hormone assays. | |
| 6.
Comparison
to predicate
device | The Boehringer Mannheim Elecsys® PreciControl TSH is substantially
equivalent to other products in commercial distribution intended for similar
use. Most notably it is substantially equivalent to the Elecsys® TSH CalSet
(K961491). | |
| | The following table compares the Elecsys® PreciControl TSH with the
predicate device, Elecsys® TSH CalSet. | |
| | Similarities:
• Same formulation. | |
| | •Same matrix: Horse serum matrix | |
| | •Same analyte: recombinant Thyroid Stimulating Hormone | |
| | •Standardization: World Health Organization (WHO-reference material #
80/558) | |
| | •Storage conditions: 2 - 8°C | |
| | •Application test system: Elecsys® 2010 | |
| | •Reconstitution: none required, liquid | |
| | •Open vial stability: 4 weeks at 2 - 8°C | |
| | •Manufacturer: Boehringer Mannheim Germany | |
2
Image /page/2/Picture/0 description: The image contains 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 white circle with the word "boehringer" written inside. To the right of the logo is the word "Diagnostics" in a serif font.
510(k) Summary, Continued
Comparison
to predicate
device cont.
Differences:
| Feature | Elecsys® TSH CalSet | Elecsys ® PreciControl TSH |
|---|---|---|
| Target | ||
| concentration | 0 and 1.4 μU/mL | 0.18 μU/mL |
| Intended Use | Calibration of the Elecsys | |
| TSH Assay | Monitoring assays for TSH |
Performance Characteristics:
| Feature | Elecsys® TSH CalSet | Elecsys ® PreciControl TSH |
|---|---|---|
| Open Vial | ||
| Stability | 4 weeks at 2 - 8°C | 4 weeks at 2 - 8°C |
| Value | ||
| Assignment | standardized against WHO- | |
| reference material (#80/558) | standardized against WHO- | |
| reference material (#80/558) |