(34 days)
K 0208631
Not Found
No
The summary describes a quality control material for a blood coagulation test, not a device that processes data or images using AI/ML.
No.
The "CoaguChek XS PT Controls" are quality control materials for a medical device (CoaguChek XS monitor and test strips) that performs PT testing, but they are not themselves used to treat or diagnose a condition. They ensure the accuracy of the diagnostic test.
No.
The device is a control for a diagnostic device (CoaguChek XS monitor and CoaguChek XS PT test strips), used for system checks and quality control, not for diagnosing patients directly.
No
The device description explicitly states it consists of lyophilized non-human plasma and a plastic bulb pipette, which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the controls are for "system checks and quality control of Prothrombin Time Testing with the CoaguChek XS monitor and CoaguChek XS PT test strips." This indicates that the product is used in vitro (outside the body) to assess the performance of a diagnostic test (Prothrombin Time testing).
- Device Description: The description mentions "lyophilized non-human plasma" which is a biological material used in laboratory testing.
- Function: The controls are used to verify the accuracy and reliability of the CoaguChek XS system for PT testing, which is a diagnostic procedure.
Therefore, based on the provided information, the CoaguChek XS PT Controls fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
"CoaguChek XS PT Controls are intended for system checks and quality control of Prothrombin Time Testing with the CoaguChek XS monitor and CoaguChek XS PT test strips."
Product codes (comma separated list FDA assigned to the subject device)
GGN
Device Description
"The control consists of lyophilized non-human plasma with varying levels of coagulation factors, which is reconstituted for use with diluent from a plastic bulb pipette."
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
"professional health care providers"
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)
"Precision: Level 1: overall CV 1.1% Level 1: overall CV 4.80%"
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
"Precision: Level 1: overall CV 1.1% Level 1: overall CV 4.80%"
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.
K 0208631
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
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
0
Kα63823
510(k) Summary
| 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) 521-3723 | |
| JAN 29 2007 | |
| Contact person: Theresa Ambrose Bush | |
| Date prepared: December 13, 2006 | |
| Device Name | Proprietary name: CoaguChek XS PT Controls |
| Common name: CoaguChek XS PT Controls | |
| Classification name: System, Multipurpose for in vitro coagulation studies | |
| Establishment registration | The establishment registration number for Roche Diagnostics Mannheim is 961026. |
| Device Description | The control consists of lyophilized non-human plasma with varying levels of coagulation factors, which is reconstituted for use with diluent from a plastic bulb pipette. |
| Intended Use | CoaguChek XS PT Controls are intended for system checks and quality control of Prothrombin Time Testing with the CoaguChek XS monitor and CoaguChek XS PT test strips. |
| Substantial equivalence : Predicate Device | CoaguChek XS PT Controls is substantially equivalent to other products in commercial distribution intended for similar use. We claim equivalency to the currently marketed CoaguChek PT S System Controls cleared in the PT S Test Strips and Controls for the CoaguChek S System (K 0208631). |
| Comparison table | The below tables compare CoaguChek XS PT Controls with the predicate device, CoaguChek PT S System Controls (K0208631). |
| Characteristic | CoaguChek XS PTControls | Predicate Device CoaguChek PT S System Controls (K0208631) | |
|---|---|---|---|
| -- | ---------------- | ------------------------- | ------------------------------------------------------------ |
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| Intended Use | CoaguChek XS PT Controls are intended for system checks and quality control of Prothrombin Time Testing with the CoaguChek XS monitor and CoaguChek XS PT test strips. for quality control testing using CoaguChek PT S Test ts with the CoaguChek S System by professional health care providers |
|---|---|
| Stability | Unopened: |
| • Store at 2-8°C until expiration date | |
| Reconstituted: | |
| • Stable for 30 minutes | |
| Unopened: | |
| • Store at 2-8°C. Do not freeze | |
| • When stored at room temperature, controls are stable for 90 days or until expiration date, whichever comes first, when stored at room temperature (below 32°C). | |
| Reconstituted | |
| • Stable for 30 minutes | |
| Matrix | Same Lyophilized non-human plasma (with varied levels of coagulation factors) with aqueous diluent, stabilizers, and preservative. |
| Levels | Same Two levels: |
| Level 1 normal | |
| Level 2 abnormal | |
| Handling | Same Lyophilized plasma that is reconstituted with diluent from a plastic bulb pipette, mixed by swirling, set aside while meter is activated, and used within 30 minutes of reconsititution. |
| Precision | Level 1: overall CV 1.1% Level 1: overall CV 4.80% |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (USA). The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or other bird-like figure, with three stylized lines representing wings or feathers. Below the bird-like figure are three wavy lines, possibly representing water or movement.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
ROCHE Diagnostics Corp. C/O Theresa Ambrose Bush 9115 Hague Road P.O. Box 50416 Indianapolis, Indiana 46250
Re: K063823
JAN 2 9 2007
Trade/Device Name: CoaguChek® XS PT Controls Regulation Number: 21 CFR 864.5425 Regulation Name: Multipurpose System for In Vitro Coagulation Studies Regulatory Class: Class II Product Code: GGN Dated: December 22, 2006 Received: December 26, 2006
Dear Ms. Bush:
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. 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
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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) 276-0450. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrf/industry/support/index.html.
Sincerely yours,
Robert H. Becker Jr.
Robert L. Becker, Jr., MD. Ph Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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cc: HFZ-401 DMC
HFZ-404 510(k) Staff HFZ- 440 Division D.O.
and the state of the states of the states of the states of the states of the states of the states of the states of the states of the states of the states of the states of the
5
Indications for Use
510(k) Number (if known):
100000
Device Name: CoaguChek XS PT Controls
Indications For Use:
CoaguChek XS PT Controls are intended for system checks and quality control of Prothrombin Time Testing with the CoaguChek XS monitor and CoaguChek XS PT test strips.
Prescription Use XXXX (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Jorphine Bautista
Division Sig
Jivisi
Office of In Vitro Thagnostic Device Evaluation and Safe
(4) K063823