(127 days)
Not Found
No
The description details a turbidimetric assay for measuring C3c, a standard laboratory technique that does not inherently involve AI/ML. There are no mentions of AI, ML, or related concepts in the provided text.
No.
The device is an in vitro quantitative immunological determination system used for diagnostic purposes, not for treating or preventing disease.
Yes
The "Intended Use / Indications for Use" states that the measurements "aid in the diagnosis of immunologic disorders."
No
The device description clearly states it is a "Test System" based on a turbidimetric method, which involves physical reagents and an analyzer (implied by the predicate device being on a Roche COBAS Integra Analyzer). This indicates a hardware component is essential for the device's function.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" explicitly states "For the in vitro quantitative immunological determination of human complement C3c in serum and plasma." This clearly indicates the device is used to test samples taken from the human body (serum and plasma) outside of the body ("in vitro") to diagnose or aid in the diagnosis of a medical condition ("immunologic disorders").
- Device Description: The description details a test system that analyzes a biological sample (serum and plasma) using a specific method (immunological determination of C3c) to obtain a result that is used for diagnostic purposes.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K951595) is a strong indicator that this device has gone through the FDA's 510(k) clearance process, which is specifically for medical devices, including IVDs. The predicate device itself is also named "Tina-quant Complement C3c Test System," further confirming the nature of the device.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For the in vitro quantitative immunological determination of human complement C3c in serum and plasma. Measurements of these proteins aid in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.
Product codes
CZW
Device Description
The Tina-quant Complement C3c ver.2 Test System is based on the activation of the complement system which takes place via a classical and an alternative route. The two pathways come together in a joint terminal path. As a complement factor C3 is a factor common to both pathways, the concentration of C3 and its degradation products (including C3c) can be evaluated as a parameter for activation of the complement system. Human C3c forms a precipitate with a specific antiserum which is determined turbidimetrically.
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.5240 Complement components immunological test system.
(a)
Identification. A complement components immunological test system is a device that consists of the reagents used to measure by immunochemical techniques complement components C1q , C1r , C1s , C2 , C3 , C4 , C5 , C6 , C7 , C8 , and C9 , in serum, other body fluids, and tissues. Complement is a group of serum proteins which destroy infectious agents. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.(b)
Classification. Class II (performance standards).
0
:
NOV 2 9 2001
510(k) Summary
| Introduction | According to the requirements established in the Food and Drug
Administration's guidance document entitled "The New 510(k) Paradigm:
Alternate Approaches to Demonstrating Substantial Equivalence in Premarket
Notifications", the following information provides sufficient detail to
understand the basis for a determination of substantial equivalence. |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1) Submitter
name, address,
contact | Roche Diagnostics Corporation
9115 Hague Rd.
Indianapolis, IN 46250
(317) 576-7643
Contact Person: Helen T. Torney
Date Prepared: November 12, 2001 |
| 2) Device name | Proprietary name: Tina-quant Complement C3c Test System
Common name: Complement C3c Test
Classification name: Complement components immunological test system |
| 3) Predicate
device | We claim substantial equivalence to the currently marketed Tina-quant
Complement C3c Test System on Roche COBAS Integra Analyzers
(K591595). |
1
510(k) Summary, Continued
| 4) Device
Description | The Tina-quant Complement C3c ver.2 Test System is based on the activation
of the complement system which takes place via a classical and an alternative
route. The two pathways come together in a joint terminal path. As a
complement factor C3 is a factor common to both pathways, the
concentration of C3 and its degradation products (including C3c) can be
evaluated as a parameter for activation of the complement system. Human
C3c forms a precipitate with a specific antiserum which is determined
turbidimetrically. |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 5) Intended use | For the in vitro quantitative immunological determination of human
complement C3c in serum and plasma. |
| 6.) Substantial
equivalence | The table below indicates the similarities between the modified Tina-quant
Complement C3c ver.2 Test System on COBAS Integra analyzers and the
predicate, Tina-quant Complement C3c Test System on COBAS Integra
analyzers (K951595). In summary, the Tina-quant Complement C3c ver.2
Test System described in this submission is, in our opinion, substantially
equivalent to the predicate device.
Comparison of Proposed and Predicate Device |
| Topic | Modified
Tina-quant
Complement C3c ver.2 | Tina-quant Complement C3c
(cleared K951595) |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For the in vitro
quantitative
immunological
determination of human
complement C3c in serum
and plasma. | For the in vitro quantitative
immunological determination of
human complement C3c in serum. |
| Indication for Use | Measurements of these
proteins aid in the
diagnosis of immunologic
disorders, especially those
associated with
deficiencies of
complement components. | Measurements of these proteins aid
in the diagnosis of immunologic
disorders, especially those associated
with deficiencies of complement
components. |
| Sample Type | Human serum and plasma | Human serum |
| Analytical Sensitivity | 0.11 g/L (11 mg/dL) | 0.262 g/L (26mg/dL) |
| Wavelength | 340/659 nm | 340/659 nm |
| Analyzer | COBAS Integra analyzers | COBAS Integra analyzers |
·
2
| Topic | Modified
Tina-quant
Complement C3c ver.2 | Tina-quant Complement C3c
(cleared K951595) |
|-----------------|------------------------------------------------|------------------------------------------------|
| Measuring Range | 0.11-6.0 g/L (11-600
mg/dL) | 0.55-8.9 g/L (55-890 mg/dL) |
.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 2 9 2001
Ms. Helen Torney Centralized Diagnostics Regulatory Submissions Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457
Re: K012361
Trade/Device Name: Tina-Quant Complement C3c ver.2 Test System Regulation Number: 21 CFR 866.5240 Regulation Name: Complement components immunological test system Regulatory Class: Class II Product Code: CZW Dated: November 12, 2001 Received: November 14, 2001
Dear Ms. Torney:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection b retar pe issubstantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the encreativent of the enactment date of the Medical Device Amendments, or to commence phor to May 20, 1978, in example with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). alla Cosmetic Act (1101) that do not request of the general controls provisions of the Act. The T ou may, dicrerere, mains of the Act include requirements for annual registration, listing of general controls provisions of vactice, 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 IT your device is olassified (600 as controls. Existing major regulations affecting your device can may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may ou found in the Overnments concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be devisou that I Dr unation that your device complies with other requirements of the Act that I DTT has made a actern regulations administered by other Federal agencies. You must or any I catales and regisments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of A rate 6075, accems (21 CFR Part 820); and if applicable, the electronic forth in the quind) byers provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2 -
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrb/dsma/dsmamain.html".
Sincerely yours,
Steven Gutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): KOI236 | Device Name: Tina-quant Complement C3c ver.2 Test System
Indications for Use:
For the in vitro quantitative immunological determination of human complement C3cin serum and plasma. Measurements of these proteins aid in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan S. Altare
vision Sign-Off) vision of Clineal Laboratory Devices
510(k) Number K012361
Prescription Use V (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)