(295 days)
Not Found
No
The device description relies on a physical mechanism (iron particle movement stopping upon clotting) and a simple timer, with no mention of AI/ML terms or complex data processing beyond basic correlation analysis in performance studies.
No.
This device is for quantitative diagnostic testing (prothrombin time testing) to measure blood clotting, not to provide therapy.
Yes
The device is described as performing "quantitative prothrombin time (PT) testing" using fresh capillary blood. Prothrombin time testing is a diagnostic procedure used to assess blood clotting ability, which aids in the diagnosis and monitoring of various medical conditions.
No
The device description explicitly details hardware components (test strip with reagent and iron particles, meter with oscillating magnetic field) and their physical interaction with blood to measure clotting time. This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "For quantitative prothrombin time (PT) testing in fresh capillary blood". This indicates that the device is used to test a biological sample (blood) outside of the body to obtain diagnostic information (prothrombin time).
- Device Description: The description details how the device interacts with the blood sample on a test strip to measure a specific biological process (blood clotting).
- Performance Studies: The performance studies involve comparing results obtained from testing blood samples.
These characteristics align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
For quantitative prothrombin time (PT) testing in fresh capillary blood with the CoaguChek System by properly selected and suitably trained patients (or their care givers) on the prescription of the treating doctor.
Product codes
Not Found
Device Description
• The CoaguChek test strip contains reagent and iron particles. Blood mixes with these reagents and particles on the test strip. At the same time, the meter starts a timer. The iron particles move in response to an oscillating magnetic field. When the blood clots, the particles stop moving. The meter stops the timer and displays the result.
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
properly selected and suitably trained patients (or their care givers) on the prescription of the treating doctor.
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
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Summary of Performance Studies
A study was conducted comparing test results obtained by trained patients with those obtained by health care professionals, when both were using the CoaguChek PST System. The correlation was very good, as indicated by the following statistics: N = 315 observations, Slope = 0.973, Intercept = 0.05, and Correlation Coefficient = 0.966. This study shows that trained patients are able to obtain results that are as accurate as those obtained by health care professionals trained in the use of the CoaguChek System.
Key Metrics
N = 315 observations, Slope = 0.973, Intercept = 0.05, and Correlation Coefficient = 0.966.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.7750 Prothrombin time test.
(a)
Identification. A prothrombin time test is a device used as a general screening procedure for the detection of possible clotting factor deficiencies in the extrinsic coagulation pathway, which involves the reaction between coagulation factors III and VII, and to monitor patients receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or pulmonary embolism).(b)
Classification. Class II (performance standards).
0
Boehringer Mannheim Corporation
CoaguChek® PST System 510(k) Premarket Notification
510(k) Summary
APR 2 2 1997
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.
| 1) Submitter name, address, contact | Boehringer Mannheim Corporation 9115 Hague Rd. Indianapolis, IN 46250 (317) 845-2000 |
|---|---|
| Contact Person: Mike Flis | |
| Date Prepared: June 28, 1996 | |
| 2) Device name | Proprietary name: CoaguChek™ PST System |
| Common name: prothrombin time test | |
| 3) Predicate device | We claim substantial equivalence to Boehringer Mannheim's CoaguChek™ System. |
| 4) Device Description | • The CoaguChek test strip contains reagent and iron particles. Blood mixes with these reagents and particles on the test strip. At the same time, the meter starts a timer. The iron particles move in response to an oscillating magnetic field. When the blood clots, the particles stop moving. The meter stops the timer and displays the result. |
Continued on next pagei
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1
Boehringer Mannheim Corporation
| 510(k) Summary, Continued |
|---|
| --------------------------- |
| 5) Intended use | For quantitative prothrombin time (PT) testing in fresh capillary blood with the CoaguChek System by properly selected and suitably trained patients (or their care givers) on the prescription of the treating doctor. |
|---|---|
| 6) Comparison to predicate device | The Boehringer Mannheim CoaguChek PST System is substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed Boehringer Mannheim CoaguChek System. The following tables compare the CoaguChek PST with the predicate device. |
A study was conducted comparing test results obtained by trained patients with those obtained by health care professionals, when both were using the CoaguChek PST System. The correlation was very good, as indicated by the following statistics: N = 315 observations, Slope = 0.973, Intercept = 0.05, and Correlation Coefficient = 0.966. This study shows that trained patients are able to obtain results that are as accurate as those obtained by health care professionals trained in the use of the CoaguChek System.
In a previous Premarket Notification (#K930454) Boehringer Mannheim demonstrated the CoaguChek System was compared against Boehringer Mannheim's CoaguChek Plus System and the MLA 700 Analyzer. In August, 1993, FDA determined the CoaguChek System was substantially equivalent to those test systems.
Continued on next page
2
510(k) Summary, Cont'd
SIMILARITIES
......
| Feature Feature | CoaguChek System
(the Predicate Device) | CoaguChek PST System (the New
Device) |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Principle of Operation | The CoaguChek test strip contains reagent and iron
particles. Blood mixes with these reagents and particles
on the test strip. At the same time, the meter starts a
timer. The iron particles move in response to an
oscillating magnetic field. When the blood clots, the
particles stop moving. The meter stops the timer and
displays the result. | Same. Principle of operation is not
effected by introduction of new user
group. |
| Meter Calibration
Procedure | Test strip package insert and Meter User's Manual
instruct the user to change the Code Chip with each new
package of test strips. | Same. A Code Chip is provided in each
package of test strips. The meter
calibration procedure is not effected by
introduction of new user group. |
| Meter Cleaning | Meter User's Manual describes the cleaning procedure
which consists of wiping strip guide and other surfaces
with a cloth dampened with 10% household bleach
solution. | Same. Meter cleaning procedure is not
effected by introduction of new user
group. |
| Hematocrit Range | Hematocrit ranges between 32-52% do not significantly
affect test results. | Same. Test strip and meter design were
not effected by the proposed modification
(i.e., new user group). |
| Fail-Safe Mechanisms | Fail-safe mechanisms built into meter and error code
messages were described in 510(k) file #K930454. | Same. The meter was initially designed
for use by patients so no redesign was
required. |
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3
CoaguChek® PST System 510(k) Premarket Notification
510(k) Summary, Cont'd
SIMILARITIES, Cont'd
ital
i Op
| Feature | CoaguChek System
(the Predicate Device) | CoaguChek PST System (the New
Device) |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Storage and Operating
Condition Limits | Test Strips & Liquid Controls: Store strips and liquid
controls in refrigerator at +35°F to +45°F until ready to
use. Do not freeze. Test strips are stable for 60 days or
the expiration date, whichever comes first, when stored at
room temperature (below 86°F). Remove test strip foil
pouch and control vial from refrigerator for at least five
minutes before performing test. The strip pouch and
control vial should be at room temperature (65°F - 90°F)
before opening.
Meter: 65°F - 90°F, 10-85% relative humidity (without
condensation). | Same. The recommended storage and
operating conditions are not effected by
the introduction of the new user group. |
| Measuring Range | The CoaguChek system has a PT measuring range of 9.6
to 36.9 seconds (NAS) and 0.64 to 9.5 INR. | Same. |
| Sensitivity | The CoaguChek System is sensitive to deficiencies of
Factor II, V, VII, and X. | Same. |
| Meter Size | 2.2 x 5.5 x 8.8 inches
1.5 lb. | Same. |
| Meter Memory | 30 tests with time and date | Same. |
4
510(k) Summary, Cont'd
DIFFERENCES
| Feature | CoaguChek System
(the Predicate Device) | CoaguChek PST System (the New Device) |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Recommended Quality
Control Strategy | Health care professionals are directed to perform daily
control testing as required by CLIA '88. A two-level
Electronic Quality Control cartridge is available from
Boehringer Mannheim as well as two liquid controls to
meet the regulatory requirements. | Two levels of control should be tested
upon receipt of each test strip carton
and each day of use. |
| User Environment and
Qualifications | Cleared for use by health care professionals, including
Home Health Care nurses, within operating conditions
specified in User's manual. As noted on previous page,
the recommended storage and operating conditions are
not effected by the introduction of the new user group. | Intended for use by health care
professionals and properly selected and
suitable trained patients within
operating conditions specified in device
labeling. |
5
510(k) Summary, Cont'd
DIFFERENCES, Cont'd
| Feature | CoaguChek System
(the Predicate Device) | CoaguChek PST System (the New
Device) |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Test System Labeling | 510(k) cleared labeling intended for health care
professional. Labeling for predicate device is provided in
attachment 8. | Labeling content intended for patient
rewritten to 7th grade reading level or
lower.
Additional labeling created to assist
professionals with suitable selection and
proper training of patients.
Labeling for proposed test kit is provided
in attachment 7. |
| Specimen Collection | Test procedure is described in the package insert and the
Meter User's Manual. The labeling describes dosing test
strips with either fresh capillary or venous blood
samples. | Patient is limited to testing only fresh
capillary whole blood samples. All other
aspects of test procedure (e.g., strip
insertion into meter before dosing strip)
are not effected by introduction of new
user group. |