(18 days)
Not Found
No
The summary describes a calibration set for an immunoassay system, 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 a calibrator for an immunoassay system, used to ensure the accuracy of quantitative LH assays. It does not directly treat, prevent, or diagnose a disease or condition in a patient, which are characteristics of a therapeutic device.
No
Explanation: This device is a calibrator used to ensure the accuracy of an immunoassay system. It does not diagnose a condition directly; rather, it's a tool for quality control in diagnostic testing.
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 LH CalSet II is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states it is used for "calibrating the quantitative LH assay on the Elecsys immunoassay systems." This indicates it is used in a laboratory setting to ensure the accuracy of a diagnostic test (the LH assay).
- Device Description: It is a "lyophilized human serum matrix with added LH." This is a reagent used in an in vitro test.
- Predicate Device: The predicate device listed (Elecsys LH CalSet) is also a calibrator for an immunoassay, which are typically classified as IVDs.
Calibrators for diagnostic assays are considered IVD devices because they are essential components used in vitro (outside the body) to establish the relationship between the signal measured by the instrument and the concentration of the analyte (LH in this case) in a patient sample. This calibration is crucial for obtaining accurate diagnostic results.
N/A
Intended Use / Indications for Use
The Elecsys LH CalSet II is used for calibrating the quantitative LH assay on the Elecsys immunoassay systems.
Product codes (comma separated list FDA assigned to the subject device)
JIT
Device Description
Elecsys LH CalSet II consists of a lyophilized human serum matrix with added LH.
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
MAY 12 2003
510(k) Summary - Elecsys LH 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 Corporation |
| 9115 Hague Rd | |
| Indianapolis IN 46250 | |
| (317) 521-3831 |
Contact person: Theresa M. Ambrose
Date prepared: April 24, 2003 |
| Device Name | Proprietary name: Elecsys LH CalSet II
Common name: Calibrator
Classification name: Calibrator, secondary |
| Device description | Elecsys LH CalSet II consists of a lyophilized human serum matrix with added LH. |
| Intended use | The Elecsys LH CalSet II is used for calibrating the quantitative LH assay on the Elecsys immunoassay systems. |
| Predicate Device | We claim substantial equivalence to the currently marketed Elecsys LH CalSet . (K964694). |
:
:
1
510(k) Summary -- COBAS Integra Creatinine plus ver.2,
continued
The following table compares the Elecsys LH CalSet II and the predicate Reagent Summary device.
| Topic | LH CalSet (K964694) | LHCalSet II (Modified Device) |
|---|---|---|
| Intended Use | The Elecsys LH CalSet is used | |
| for calibrating the quantitative | ||
| LH assay on the Elecsys | ||
| 1010/2010 and MODULAR | ||
| ANALYTICS E170 | ||
| immunoassay system. | The Elecsys LH CalSet II is used for | |
| calibrating the quantitative LH assay | ||
| on the Elecsys immunoassay systems. | ||
| Matrix | Buffer/ protein matrix | Human serum matrix |
| Storage form | Liquid | Lyophilized |
| Levels | Low: approx. 1 mIU/mL | |
| High: approx 45 mIU/mL | Same | |
| Standardization | Calibrated against 2nd | |
| International Standard (NIBSC) | ||
| 80/552 | Same | |
| Stability | Unopened at 2-8°C: up to | |
| expiration date | ||
| After opening, in aliquots: 12 | ||
| weeks at 2-8°C | ||
| Onboard 2010/1010 (20-25 °C): | ||
| up to 5 hours total | ||
| E170: use only once | Store at 2-8°C | |
| Lyophilized calibrators : up to | ||
| expiration date | ||
| Reconstituted: at -20 °C: 1 month | ||
| (freeze only once) | ||
| On board: use only once |
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with three curved lines representing its wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 1 2 2003
Theresa M. Ambrose, Ph.D., FACB Regulatory Principle, Centralized Diagnostics Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457
Re: K031299
Trade/Device Name: Elecsys LH CalSet II Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: April 24, 2003 Received: May 1, 2003
Dear Dr.Ambrose:
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
3
Page 2 -
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 a 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. 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,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): N/A
Device Name: Elecsys LH CalSet II
Indications For Use:
The Elecsys LH CalSet II is used for calibrating the quantitative LH assay on the Elecsys immunoassay systems.
Lan Coogs.
(Division Sign-Off)
Division of Clinical Laborator
510(k) Number K031299.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) い Prescription Use OR Over-The-Counter Use (Per 21 CFR 801.109)
(Optional Format 1-2-96)