(19 days)
Not Found
No
The summary describes a quality control product for immunoassays, which is a chemical reagent, not a software or imaging device that would typically incorporate AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is described as a quality control product for immunoassays, not for the treatment or diagnosis of a disease or condition in a patient.
No
Explanation: The device is a quality control product used to verify the performance of other immunoassay systems (Elecsys C-Peptide and Elecsys Insulin immunoassays). It does not directly diagnose a patient's condition.
No
The device description clearly states it is a lyophilized product consisting of synthetic human C-Peptide and recombinant human insulin in a buffered equine serum matrix, indicating it is a physical reagent, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is used for "quality control of the Elecsys C-Peptide and Elecsys Insulin immunoassays on the Elecsys immunoassay systems." Quality control materials for in vitro diagnostic tests are themselves considered IVDs.
- Device Description: The description details a "lyophilized product consisting of synthetic human C-Peptide and recombinant human insulin in a buffered equine serum matrix." This is a typical format for a control material used in laboratory testing.
- Predicate Device: The mention of a predicate device (K032089; Elecsys® PreciControl Cardiac) which is also a quality control material for an immunoassay further supports its classification as an IVD.
The purpose of this device is to verify the performance of other IVD tests (the Elecsys C-Peptide and Elecsys Insulin immunoassays), which is a key function within the realm of in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Elecsys® PreciControl MultiAnalyte is used for quality control of the Elecsys C-Peptide and Elecsys Insulin immunoassays on the Elecsys immunoassay systems.
Product codes (comma separated list FDA assigned to the subject device)
JJY
Device Description
The Elecsys® PreciControl MultiAnalyte is a lyophilized product consisting of synthetic human C-Peptide and recombinant human insulin in a buffered equine serum matrix. During manufacture, the analytes are spiked into the matrix at the desired concentration levels.
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)
The Elecsys® PreciControl MultiAnalyte was evaluated for value assignment and stability.
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
JAN - 7 2004
| JAN - 7 2004 | |
|---|---|
| 510(k) Summary K033937 | |
| 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 Road | |
| Indianapolis, IN 46250 | |
| 317-521-3723 |
Contact Person: Theresa M. Ambrose
Date Prepared: December 18, 2003 |
| Device Name | Proprietary name: Elecsys® PreciControl MultiAnalyte
Common name: PreciControl MultiAnalyte
Classification name: Multi-analyte Controls (assayed and unassayed) |
| Predicate device | The Elecsys® PreciControl MultiAnalyte is substantially equivalent to the currently marketed Elecsys® PreciControl Cardiac (K032089). |
| Device Description | The Elecsys® PreciControl MultiAnalyte is a lyophilized product consisting of synthetic human C-Peptide and recombinant human insulin in a buffered equine serum matrix. During manufacture, the analytes are spiked into the matrix at the desired concentration levels. |
| Intended use | The Elecsys® PreciControl MultiAnalyte is used for quality control of the Elecsys C-Peptide and Elecsys Insulin immunoassays on the Elecsys immunoassay systems. |
| Continued on next page | |
:
1
510(k) Summary, Continued
The Elecsys® PreciControl MultiAnalyte is substantially equivalent to the Comparison to predicate currently marketed Elecsys® PreciControl Cardiac (K032089).The below device tables compare Elecsys® PreciControl MultiAnalyte with the predicate device, Elecsys® PreciControl Cardiac (K032089).
Similarities
. 7
| Characteristic | Elecsys®
PreciControl
MultiAnalyte | Predicate device
Elecsys® PreciControl
Cardiac |
|----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | PreciControl
MultiAnalyte is used
for quality control of
the Elecsys C-Peptide
and Elecsys Insulin
immunoassays on the
Elecsys immunoassay
systems. | PreciControl Cardiac is
used for quality control
of the Elecsys CK-MB,
Digoxin, Myoglobin,
and NT-proBNP
immunoassays on the
Elecsys immunoassay
systems. |
| Levels | Two | Same |
| Format | Lyophilized | Same |
| Handling | Reconstitute with
exactly 2.0 mL distilled
water and allow to
stand closed for 15
minutes. | Same |
Continued on next page
2
510(k) Summary, Continued
Differences
្រុះ
| Characteristic | Elecsys®
PreciControl
MultiAnalyte | Predicate device
Elecsys® PreciControl
Cardiac |
|----------------|---------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Matrix | Equine serum with
added C-Peptide and
insulin | Human serum with
added CK-MB,
digoxin, myoglobin,
and NT-proBNP |
| Stability | Unopened:
• Store at 2-8°C until
expiration date
Reconstituted:
• At -20°C : 1 months
• On the analyzers : 3 hrs | Unopened:
• Store at 2-8°C until
expiration date
Reconstituted:
• At 2-8°C : 3 days
• At -20°C : 3 months
• On the analyzers : 3 hrs |
Performance Characteristics
The Elecsys® PreciControl MultiAnalyte was evaluated for value assignment and stability.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure, with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged in a circular fashion around the bird symbol.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN - 7 2004
Theresa M. Ambrose, Ph.D. Regulatory Principal Roche Diagnostics Corporation 9115 Hague Road PO Box 50457 Indianapolis, IN 46250-0457
K033937 Re:
Trade/Device Name: Elecsys® PreciControl MultiAnalyte Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: December 18, 2003 Received: December 19, 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 for association to May 28, 1976, the enactment date of the Medical Device Amendments, or to commerce prices 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). and Oosmeter for ( ro ) re re re, subject to the general controls provisions of the Act. The r ou may, atteres 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 your de roo subject to such additional controls. Existing major regulations affecting your device it may be subject to back and Federal Regulations (CFR), Parts 800 to 895. In addition, I'DA 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 or any I 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).
4
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 Sutman
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
5
Indications for Use Statement
510(k) Number (if known): N/A K 0339 37
Device Name: Elecsys® PreciControl MultiAnalyte
Indications For Use:
The Elecsys® PreciControl MultiAnalyte is used for quality control of the Elecsys C-Peptide and Elecsys Insulin immunoassays on the Elecsys immunoassay systems.
Prescription Use (Per 21 CFR 801 409)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Carl Bensen
Division Sign Off
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)_E033937