(14 days)
Not Found
No
The document describes a calibration set for an immunoassay system, which is a chemical reagent used to standardize the measurement of a specific analyte (AFP). There is no mention of any computational or algorithmic processing, let alone AI or ML. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
No.
The device is a calibrator used for an assay, not for treating a condition.
No
This device is a calibrator for an assay, not a diagnostic device itself. It is used to ensure the accuracy of a diagnostic assay on immunoassay systems.
No
The device description explicitly states it consists of a lyophilized human serum matrix, which is a physical substance, not software.
Based on the provided information, the Elecsys AFP CalSet II is likely an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states it is used for "calibrating the quantitative AFP assay on the Elecsys immunoassay systems." Calibration materials for diagnostic tests are considered IVDs as they are essential components for ensuring the accuracy and reliability of the diagnostic results.
- Device Description: It is a "lyophilized human serum matrix with added AFP." This describes a biological material used in a laboratory setting for testing purposes.
- Predicate Device: The predicate device listed, "Elecsys® AFP Calset (K981282)," is also a calibration set for an AFP assay. Calibration sets for diagnostic tests are typically classified as IVDs.
While the document doesn't explicitly state "In Vitro Diagnostic Device," the function and nature of the product, particularly its role in calibrating a diagnostic assay, strongly indicate that it falls under the definition of an IVD.
N/A
Intended Use / Indications for Use
The Elecsys® AFP CalSet II is used for calibrating the quantitative AFP assay on the Elecsys immunoassay systems.
Product codes (comma separated list FDA assigned to the subject device)
JIT
Device Description
The Elecsys® AFP CalSet II consists of a lyophilized human serum matrix with added AFP in two concentrations.
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
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
NOV 2 3 2004
510(k) Summary - Elecsys® AFP CalSet II
| 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 |
|---|---|
| Submitter name, address, contact | Roche Diagnostics |
| 9115 Hague Rd | |
| Indianapolis IN 46250 | |
| (317) 521-3544 | |
| Contact person: Kay A. Taylor | |
| Date prepared: November 8, 2004 | |
| Device Name | Proprietary name: Elecsys® AFP CalSet II |
| Common name: Calibrator | |
| Classification name: Calibratory, secondary | |
| Device description | The Elecsys® AFP CalSet II consists of a lyophilized human serum matrix with added AFP in two concentrations. |
| Intended use | The Elecsys AFP CalSet II is used for calibrating the quantitative AFP assay on the Elecsys immunoassay systems. |
| Predicate Device | We claim substantial equivalence to the currently marketed Elecsys® AFP Calset. (K981282). |
r
1
510(k) Summary - Elecsys® AFP CalSet II, continued
Reagent Summary The following table describes the similarities and differences between the Elecsys® AFP CalSet II and the Elecsys AFP CalSet.
| Topic | Elecsys® AFP CalSet
(K981282) | Elecsys® AFP CalSet II
(Modified Device) |
|-----------------|---------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Elecsys AFP CalSet is used for calibrating the quantitative AFP assay on the Elecsys immunoassay systems. | The Elecsys AFP CalSet II is used for calibrating the quantitative AFP assay on the Elecsys immunoassay systems. |
| Matrix | Buffer | Human serum |
| Storage Form | Liquid | Lyophilized |
| Levels | Low: approx. 5-6 ng/ml
High: approx. 50-60 ng/ml | Same |
| Standardization | Standardized against the 1st IRp WHO reference standard 72/225. | Same |
| Stability | 12 wks at 2-8°C:
20-25°C: | 6 wks at 2-8°C:
6 wks at -20°C: (freeze once)
20-25°C: |
| | up to 5 hours on 1010/2010
use only once on E170 | up to 5 hours on 1010/2010
use only once on E170 |
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The text is in all caps and is relatively small compared to the caduceus symbol.
Public Health Service
NOV 2 3 2004
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms Kay Taylor MT (ASCP), RAC Regulatory Program Principal Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457
Re: K043095
Trade/Device Name: Roche Diagnostics Elecsys® AFP CalSet II Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: November 8, 2004 Received: November 9, 2004
Dear Ms Taylor:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 -- Ms Kay Taylor
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
H.M. Beaty
Robert L. Becker, Jr, M.D., PhD Director Division of Immunology and Hematology Devices
Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
K43095 510(k) Number (if known): N/A
Device Name: Elecsys® AFP CalSet II
Indications For Use:
The Elecsys AFP CalSet II is used for calibrating the quantitative AFP assay on the Elecsys immunoassay systems.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)(21 CFR 807 Subpart C) Over-The-Counter Use
Maria In Chan
Dideler, Clerk-Off
Islon Slan-
Office of In Vitro Diagno ice Evaluation and Safety
510(k) K043095