The CoaguChek Pro PTN test cartridge is for the quantitative determination of the prothrombin time of freshly drawn whole blood, using the CoaguChek Pro System. It is intended for health care professional use only.

Device Description

The prothrombin time test is used to measure coagulation by activating the extrinsic pathway. The PTN test is sensitive to deficiencies of factors II, V, VII, and X. The prothrombin time is an in vitro determination of the time required for a clot to form via the extrinsic pathway. The prothrombin time is useful in monitoring the prolonged coagulation response of patients undergoing coumarin therapy. Many diseases and drugs can prolong or prevent coagulation by altering the balance of clotting factors involved in coagulation.

The PTN test is initiated by inserting a CoaguChek Pro PTN test cartridge into the instrument. The instrument reads a code on the test cartridge to determine test identity and lot number. The test cartridge contains a sample application well, a reagent chamber, and a reaction path. After the instrument heats the test cartridge, a drop of fresh, whole blood is placed on the test cartridge sample application well. Blood is drawn into the reagent chamber by capillary action, where it mixes with the reagent to initiate coagulation. The blood sample moves along the reaction path until a clot forms. The laser optical system detects the clot by monitoring blood flow; endpoint is reached when the blood stops moving. The time from sample application to clot detection is the prothrombin time. The displayed result is equivalent to laboratory plasma prothrombin time results. Because each newly-manufactured lot is calibrated to an internal reference lot, any lot-to-lot variability between reagents is corrected electronically using information coded on the lot-specific code key.

AI/ML Overview

The provided text describes the CoaguChek Pro PTN Test and Controls, intended for the quantitative determination of prothrombin time in whole blood.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document provides a comparison of performance characteristics between the CoaguChek Pro PTN Test (the new device) and its predicate device, the CoaguChek PT Test. While it does not explicitly state "acceptance criteria," the predicate device's performance often serves as a benchmark for substantial equivalence.

Claim	CoaguChek PT Test (Predicate - Benchmark)	CoaguChek Pro PTN Test (Reported Performance - New Device)
Mean Normal	12 seconds1.0 INR	12 seconds1.0 INR
Verified Assay Range	9.6 - 34.4 seconds0.64 - 8.2 INR	10.7 - 37.8 seconds0.8 - 9.9 INR
Factor Sensitivity	Factors II, V, VII, and X	Factors II, V, VII, and X
Verified Hematocrit Range	32% - 52%	23% - 53%
Precision with Controls (Between-Day CV)	Level 1: 12.6 sec (3.7%)Level 2: 23.2 sec (4.1%)	Level 1: 11.6 sec (5.2%) or 0.9 INR (10.8%)Level 2: 21.6 sec (5.5%) or 3.2 INR (11.6%)
Precision with Blood (CV)	Capillary: 17.2 sec (2.2%) CVVenous: 17.6 sec (1.9%) CV	Capillary: 17.7 sec (3.8%) CV or 2.31 INR (8.4%) CVVenous: 18.6 sec (3.3%) CV or 2.57 INR (8.2%) CV
Accuracy (Correlation with reference method)	Venous Whole Blood (vs. MLA700):N=81Y=0.859X + 1.3R=0.985	Venous Whole Blood (vs. MLA900C):N=561Y=0.974X + 0.12R=0.922

Analysis of Performance vs. Benchmark:

Mean Normal, Verified Assay Range, Factor Sensitivity: The new device (CoaguChek Pro PTN) shows equivalent or improved ranges and sensitivity compared to the predicate device.
Verified Hematocrit Range: The new device demonstrates a wider verified hematocrit range (23% - 53%) compared to the predicate (32% - 52%), indicating an improvement in applicable patient populations.
Precision:
- With Controls: The CVs for the new device controls are slightly higher than the predicate in some cases (e.g., Level 1 between-day CV is 5.2% vs 3.7%). However, the use of INR for the new device also provides additional precision information. Without explicit acceptance criteria, it's hard to definitively say if these slight differences are within acceptable limits, but they are presented for comparison.
- With Blood: Similar to controls, the CVs for the new device with blood samples are slightly higher in some instances.
Accuracy:
- The new device was compared against a different reference instrument (MLA900C for the new device vs. MLA700 for the predicate).
- The sample size for the new device's accuracy study is substantially larger (N=561) compared to the predicate (N=81).
- The R-value (0.922) for the new device's accuracy is lower than the predicate (0.985), indicating a slightly weaker linear correlation with its reference method, but still indicating a strong correlation. The slope (0.974) and intercept (0.12) are closer to the ideal 1.0 and 0, respectively, than the predicate's (0.859 and 1.3).

2. Sample size used for the test set and the data provenance

Accuracy Test Set (Venous Whole Blood):
- Sample Size: N = 561
- Data Provenance: Not explicitly stated (e.g., country of origin). The study involved "Venous Whole Blood," implying human samples, likely collected prospectively for the study given the comparison to a reference laboratory method. There is no information to indicate it was retrospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The ground truth for this medical device (prothrombin time measurement) is established by a reference laboratory method (MLA900C), not by human expert consensus or interpretation.

4. Adjudication method for the test set

Not applicable. The study compares the device's output to a quantitative measurement from a reference laboratory instrument. There is no human adjudication process described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a quantitative diagnostic test for prothrombin time, not an imaging or interpretative AI system involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the device (CoaguChek Pro PTN Test) operates as a standalone automated system. The performance characteristics presented are for the device itself, without human intervention in the measurement process other than sample application. The comparison is between the device's quantitative output and a reference laboratory instrument's output.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth for the test set (accuracy study) was established using a reference laboratory method/instrument, specifically the MLA900C for venous whole blood samples.

8. The sample size for the training set

The document does not mention a "training set" in the context of machine learning or AI. This device appears to be a traditional diagnostic instrument relying on biochemical and mechanical principles, not a machine learning model. Therefore, direct training set information is not provided.

9. How the ground truth for the training set was established

As there is no mention of a machine learning "training set," this question is not applicable. The device's internal calibration is mentioned: "Because each newly-manufactured lot is calibrated to an internal reference lot, any lot-to-lot variability between reagents is corrected electronically using information coded on the lot-specific code key." This suggests a manufacturing calibration and quality control process rather than a typical machine learning ground truth establishment for a training set.

Summary

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992492

Nov - 2 1999

510(k) Summary, Continued

(

4) DeviceDescription	The prothrombin time test is used to measure coagulation by activating theextrinsic pathway. The PTN test is sensitive to deficiencies of factors II, V,VII, and X. The prothrombin time is an in vitro determination of the timerequired for a clot to form via the extrinsic pathway. The prothrombin time isuseful in monitoring the prolonged coagulation response of patientsundergoing coumarin therapy. Many diseases and drugs can prolong orprevent coagulation by altering the balance of clotting factors involved incoagulation.
	The PTN test is initiated by inserting a CoaguChek Pro PTN test cartridge intothe instrument. The instrument reads a code on the test cartridge to determinetest identity and lot number. The test cartridge contains a sample applicationwell, a reagent chamber, and a reaction path. After the instrument heats thetest cartridge, a drop of fresh, whole blood is placed on the test cartridgesample application well. Blood is drawn into the reagent chamber bycapillary action, where it mixes with the reagent to initiate coagulation. Theblood sample moves along the reaction path until a clot forms. The laseroptical system detects the clot by monitoring blood flow; endpoint is reachedwhen the blood stops moving. The time from sample application to clotdetection is the prothrombin time. The displayed result is equivalent tolaboratory plasma prothrombin time results. Because each newly-manufactured lot is calibrated to an internal reference lot, any lot-to-lotvariability between reagents is corrected electronically using informationcoded on the lot-specific code key.
5) Intended use	The CoaguChek Pro PTN test is for the quantitative determination of theprothrombin time of freshly drawn whole blood, using the CoaguChek ProSystem.
6) Comparisonto predicatedevice	The Roche Diagnostics PTN Test and controls for the CoaguChek Pro Systemis substantially equivalent to other products in commercial distributionintended for similar use. Most notably it is substantially equivalent to thecurrently marketed Roche Diagnostics PT Test and controls for theCoaguChek System.
	Continued on next page
Similarities to
predicate
device

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510(k) Summary

The CoaguChek Pro PTN Test and Controls is similar to the CoaguChek PT Test and Controls in the following items:

Topic	Comment
Intended Use	Both are intended for the measurement of prothrombin time in whole blood samples.
Closed System	Both systems use instrument, reagent carriers, and controls that are provided by Roche and are intended to be used together.
Sample types	Both systems require whole blood samples, either venous or capillary.
Professional use	Both systems are indicated for use by health care professionals, not for over-the-counter or prescription self-testing.
Quality control procedure	The use of the reconstituted liquid controls, or the electronic quality control cartridge is the same for both systems.
Specimen collection and preparation instructions	These instructions are the same for both systems.
Test reagent dosing	For both systems, the test reagent is dosed outside of the monitor, so that there is no need for cleaning of the cartridge or strip guide or the monitor optics.
Calibration of results	Both systems are traceable to the WHO reference method.
Maintenance	No maintenance is required for either system.

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510(k) Summary, Continued

Differences from predicate device

The following table lists the major differences between the CoaguChek Pro PTN Test and Controls and the predicate CoaguChek PT Test and Controls device:

Topic	CoaguChek PT	CoaguChek Pro PTN
Operating principal	Tiny iron particles aremixed with the sample.Alternating magneticfields cause the ironparticles to move withinthe sample. Theendpoint is reachedwhen the blood clotstops the iron particlesfrom moving.	Blood is drawn into thereagent chamber bycapillary action, whereit mixes with thereagent. The bloodsample moves along thereaction path until aclot forms. The laseroptical system detectsthe clot by monitoringblood flow.
	Reagent carriers	Reagent is housedwithin a flexible plasticstrip.	Reagent is housedwithin a rigid plasticcartridge.

Performance characteristics

The following chart shows a comparison of performance characteristic claims for the CoaguChek Pro PTN test and the CoaguChek PT test.

Claim	CoaguChekPT Test (Predicate)	CoaguChek ProPTN Test
Mean Normal	12 seconds1.0 INR	12 seconds1.0 INR
Verified AssayRange	9.6 - 34.4 seconds0.64 - 8.2 INR	10.7 - 37.8 seconds0.8 - 9.9 INR
Factor Sensitivity	Factors II, V, VII, and X	Factors II, V, VII, and X

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510(k) Summary, Continued

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Performance characteristics (continued)

Claim	CoaguChekPT Test (Predicate)	CoaguChek ProPTN Test
VerifiedHematocritRange	32% - 52%	23% - 53%
Precision withcontrols	Control Mean CVBetween-DayLevel 1 12.6 sec 3.7%Level 2 23.2 sec 4.1%	Control Mean CVBetween-DayLevel 1 11.6 sec 5.2%0.9 INR 10.8%Level 2 21.6 sec 5.5%3.2 INR 11.6%
Precision withblood	Capillary17.2 sec 2.2% CVVenous17.6 sec 1.9% CV	Capillary17.7 sec 3.8% CV2.31 INR 8.4% CVVenous18.6 sec 3.3% CV2.57 INR 8.2% CV
Accuracy	Venous Whole Blood:CoaguChek vs. MLA700N=81Y=0.859X + 1.3R=0.985	Venous Whole Blood:CoaguChek Pro vs.MLA900CN=561Y=0.974X + 0.12R=0.922

の 2007年のアイデリアのアイデリアのアイデリアのアイデリアのアイデリアのアイデリアのアイデリアのアイデリア

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Image /page/4/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal is circular and features an abstract design of an eagle with its wings spread. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged around the top of the circle, and the overall design is in black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

NOV - 2 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Luann Ochs Regulatory Program Manager Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, Indiana 46250-0457

K992492 Re:

Trade Name: P1N Test Cartridges and Controls for the CoaguChek Pro System Regulatory Class: II Product Code: GJS Dated: October 7, 1999 Received: October 8, 1999

Dear Ms. Ochs:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have reviewed your becam b ro(i) its substantially equivalent (for the indications for use above and we nave determined the actested predicate devices marketed in interstate commerce stated in the enclosine) to legally manates of the Medical Device Amendments, or to devices that provision in the provisions with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Cosment Act (Act. Tournal), alorelers, listing in the Act include requirements for annual provisions of the Act. "The general othanifacturing practice, labeling, and prohibitions against misbranding and adultcration.

If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (000 aco've) and additional controls. Existing major regulations (Frediation), it may to sayou in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good A substantially Cqurvalent determinations as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to inspections, the Pood and Drug Nammounting on the end on addition, FDA may publish
comply with the GMP regulation may result in regulatory action. In addition, FDA may publi Comply with the GMT Tegarater and your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might response to your prematited as a sub-Radiation Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it docs, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

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, perroits 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"(21 CFR 807.97). Other greeral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Putman

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

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510(k) Number (if known): K 99 3497 Device Name: PTN Test and Controls for the CoaguChek Pro System Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Peter E. Moani

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K992492

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use __________

(Optional Format 1-2-96)

Roche Confidential

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Regulation Number and Section

§ 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).