(34 days)
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.
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.
Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and study for the CoaguChek XS PT Controls:
Acceptance Criteria and Device Performance
The acceptance criteria for the CoaguChek XS PT Controls are implicitly demonstrated through a comparison with a legally marketed predicate device (CoaguChek PT S System Controls, K0208631). The key performance characteristic highlighted and compared is precision (CV%).
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Predicate Device) | Reported Device Performance (CoaguChek XS PT Controls) |
|---|---|---|
| Precision (CV%) - Level 1 | Overall CV 4.80% | Overall CV 1.1% |
| Precision (CV%) - Level 2 | Not explicitly stated in the provided text for the predicate. | Not explicitly stated in the provided text for the new device. |
Note: The document only explicitly states the Level 1 precision for both the predicate and the new device. The predicate's Level 1 CV is presented as an acceptance benchmark for the new device, which the new device outperforms.
Study Details Proving Device Meets Acceptance Criteria
The provided text focuses on establishing substantial equivalence to a predicate device, primarily through direct comparison of characteristics and some performance data. It does not detail a separate, dedicated clinical or performance study with specific design and methodology as would be expected for a complex medical device. Instead, the "study" is an internal comparison to the predicate's known performance.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the precision testing of either the new device or the predicate device. It provides overall CV values, which are typically derived from multiple measurements, but the exact number of replicates, runs, or operators is not specified.
The data provenance is not explicitly mentioned (e.g., country of origin, retrospective/prospective). Given that the submission is to the FDA, it's highly probable the testing was conducted in the USA or under protocols acceptable for FDA submissions.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of device and submission. CoaguChek XS PT Controls are quality control materials for an in vitro diagnostic (IVD) device (Prothrombin Time testing). The "ground truth" for such controls is typically established by:
- Manufacturing specifications: The controls are manufactured to contain specific, known concentrations or activity levels of coagulation factors.
- Reference methods/calibrators: The target values and acceptable ranges for the controls are determined using highly accurate reference methods or clinical laboratory calibrators, not by expert interpretation of patient data.
There would be no need for expert consensus on images or clinical outcomes, as this is not a diagnostic device that interprets patient-derived data directly.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods (like 2+1, 3+1) are used when expert interpretation is required to establish a ground truth for subjective data (e.g., medical images). Since the "ground truth" for a quality control material is based on objective, quantitative measurements and manufacturing specifications, expert adjudication is not relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. MRMC studies are typically performed for diagnostic devices where human readers interpret patient cases (e.g., radiologists reading medical images) and the impact of AI assistance on their performance is evaluated. This device is a quality control material, not a diagnostic tool that assists human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is also not applicable in the traditional sense. The "device" here is a control solution, not an algorithm. Its performance is measured intrinsically (e.g., precision of its stated value), not as a standalone algorithm interpreting data.
7. The Type of Ground Truth Used
The ground truth for this device (quality control material) is based on manufacturing specifications and quantitative validation of factor levels, tied to established reference methods for Prothrombin Time. It's not based on expert consensus, pathology, or outcomes data in the way a diagnostic device would be. The "truth" is the known, manufactured value of the control material, and its performance is assessed by how consistently the CoaguChek XS system measures that known value.
8. The Sample Size for the Training Set
This information is not applicable. This device is a quality control material, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for this type of device.
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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 Diagnostics9115 Hague RdIndianapolis 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 dateReconstituted:• 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 normalLevel 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
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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
§ 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.