K Number

Device Name

George King Coumadin Plasma

Manufacturer

GEORGE KING BIO-MEDICAL, INC.

Date Cleared

2017-02-23

(288 days)

Product Code

GGN

Regulation Number

864.5425

Intended Use

The George King Coumadin® Plasma is an assayed control plasma derived from a single donor on Coumadin® therapy and is intended for in vitro diagnostic use in monitoring the accuracy of the coagulation analyzer and thromboplastin using the clottable prothrombin time/INR on an optical instrument with appropriate commercial reagents. George King Coumadin® Plasma may be used when evaluating a new lot of thromboplastin reagent or new coagulation analyzer.

Device Description

Each lot of George King Coumadin® Plasma is from a single human donor stabilized on at least 6-weeks of Coumadin® therapy. The donor plasma is obtained via plasmapheresis using 4.0% sodium citrate and frozen immediately at -70°C. The INR of the donor plasma is determined using the ACL Top 500 using RecombiPlastin 2G and each plasma is then categorized into one of the three INR levels of control material based on the testing results obtained using the following INR calculation: INR = (Patient PT / Mean of normal range) ISI. Level 1 - INR Control: 1.5-2.8 Level 2 - INR Control: 2.9-4.0 Level 3 - INR Control: >4.0

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

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Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K971219

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a control plasma used for calibrating and verifying coagulation analyzers. Its function is based on the known INR of the plasma, not on any AI/ML algorithms for analysis or interpretation. The summary explicitly states "Mentions AI, DNN, or ML: Not Found".

Therapeutic

No
This device is an in vitro diagnostic control plasma used for monitoring the accuracy of coagulation analyzers and thromboplastin, not for treating a disease or condition in a patient.

Diagnostic

The device is an assayed control plasma intended for in vitro diagnostic use in monitoring the accuracy of a coagulation analyzer and thromboplastin, not for directly diagnosing a medical condition in a patient. It is used to evaluate the performance of diagnostic equipment and reagents.

SaMD (Software as a Medical Device)

The device is a control plasma, which is a biological material used for in vitro diagnostic testing, not a software program.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is "intended for in vitro diagnostic use in monitoring the accuracy of the coagulation analyzer and thromboplastin using the clottable prothrombin time/INR". This directly aligns 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 purposes.
Device Description: The device is a control plasma derived from a human donor, which is a specimen used in laboratory testing.
User: The intended users are "trained laboratory personnel working in clinical laboratories", which are the typical settings for using IVD devices.
Performance Studies: The performance studies described (precision, reproducibility, stability) are standard types of studies conducted for IVD devices to demonstrate their analytical performance.

Therefore, based on the provided information, the George King Coumadin® Plasma clearly fits the criteria of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The intended users of the George King Coumadin® Plasma are trained laboratory personnel working in clinical laboratories.

Product codes

GGN

Device Description

The INR of the donor plasma is determined using the ACL Top 500 using RecombiPlastin 2G and each plasma is then categorized into one of the three INR levels of control material based on the testing results obtained using the following INR calculation:
INR = (Patient PT / Mean of normal range) ISI.

Level 1 - INR Control: 1.5-2.8
Level 2 - INR Control: 2.9-4.0
Level 3 - INR Control: >4.0

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

The intended users of the George King Coumadin® Plasma are trained laboratory personnel working in clinical laboratories and research centers.

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

Analytical performance
a. Precision: Precision was assessed in-house on 3 different lots of each of 3 INR ranges of GK Coumadin® Plasma on the ACL TOP 500. Precision was evaluated in accordance with CLSI EP05-A2, for 20 days with 2 runs per day and 2 replicates per run for each sample (n=80) using a specific lot of RecombiplasTin 2G. The results met pre-specified acceptance criteria of CV 4.1, Lot 1: Mean Value 4.66, n 80, Within-Run SD 0.05, CV% 1.14; Between-Run SD 0.00, CV% 0.00; Between-Day SD 0.04, CV% 1.03; Total SD 0.07, CV% 1.54.

Reproducibility for INR Range: 1.5 – 2.8, Lot 3603: Mean 2.32, n 75, Repeatability SD 0.02, CV 0.85; Between Day SD 0.05, CV 2.44; Between Site SD 0.02, CV 0.92; Reproducibility SD 0.06, CV 2.74.
Reproducibility for INR Range: 2.9-4.0, Lot 3748: Mean 3.27, n 75, Repeatability SD 0.03, CV 1.14; Between Day SD 0.12, CV 3.83; Between Site SD 0.00, CV 0.00; Reproducibility SD 0.13, CV 3.99.
Reproducibility for INR Range: >4.0, Lot 3750: Mean 4.66, n 75, Repeatability SD 0.04, CV 0.97; Between Day SD 0.11, CV 2.50; Between Site SD 0.00, CV 0.00; Reproducibility SD 0.12, CV 2.68.

Predicate Device(s)

K971219

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three faces in profile, stacked on top of each other. The faces are stylized and appear to be connected.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 23, 2017

George King Bio-Medical, Inc. Ms. Barbara Young Director of Scientific Affairs 11771 W.112" Street Overland Park, KS 66210

Re: K161316

Trade/Device Name: George King Coumadin® Plasma Regulation Number: 21 CFR 864.5425 Regulation Name: Multipurpose system for in vitro coagulation studies Regulatory Class: Class II Product Code: GGN Dated: January 20, 2017 Received: January 24, 2017

Dear Ms. Young:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Parts 801 and 809); medical device reporting (reporting of

medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800)638-2041 or (301)796-7100 or at its Internet addresshttp://www.fda.gov/MedicalDevicesforYou /Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov /MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/ Industrv/default.htm.

Sincerely,

Leonthena R. Carrington -S

Lea Carrington, MS, MBA, MT(ASCP) Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known) K161316

Device Name George King Coumadin® Plasma

Indications for Use (Describe)

The intended users of the George King Coumadin® Plasma are trained laboratory personnel working in clinical laboratories.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary (21 CFR 807.92) Coumadin® Plasma

A. Submitter George King Bio-Medical, Inc. 11771 W. 112th St Overland Park, KS 66210 Telephone: (913) 469-5464 Fax: (913) 469-0871
B. Contact Person Barbara Young Director of Laboratory Operations Telephone: (913) 469-5464 Fax: (913) 469-0871
C. Date prepared: 2-10-17
D. Device Identification

Common Name: Coumadin® Plasma Product Trade Name: George King Coumadin® Plasma

Classification Regulation: Plasma, Coagulation

E. Substantial Equivalence Information
Predicate device name: CryoCheck INR Validation Set Predicate 510(k) number: K971219 Precision BioLogic Inc. 140 Eileen Stubbs Ave, Dartmouth, NS B3B 0A9 Canada Telephone: (902) 468-6482

F. Device Description

Image /page/4/Figure/3 description: This image shows the formula for calculating INR (International Normalized Ratio). The formula is INR = (Patient PT / Mean of normal range) ISI. The formula is presented in a clear and concise manner, with each component labeled appropriately. The image is likely intended for use in a medical or laboratory setting.

Level 1 - INR Control: 1.5-2.8 Level 2 - INR Control: 2.9-4.0 Level 3 - INR Control: >4.0

G. Intended Use
The George King Coumadin® Plasma is an assayed control plasma derived from a single donor on Coumadin® therapy and is intended for use in monitoring the accuracy and control of oral anticoagulant therapy using the INR on an optical instrument with appropriate commercial reagents.

The intended users of the George King Coumadin® Plasma are trained laboratory personnel working in clinical laboratories and research centers.

H. Technical Comparison with Predicate

Similarities

ITEM	DEVICE	PREDICATE
Indications for use	George King
Coumadin® Plasma
The George King Coumadin® Plasma is an
assayed control plasma derived from a single
donor on Coumadin® therapy and is intended
for in vitro diagnostic use in monitoring the
accuracy of the coagulation analyzer and
thromboplastin using the clottable
prothrombin time/INR on an optical
instrument with appropriate commercial
reagents. George King Coumadin® Plasma
may be used when evaluating a new lot of
thromboplastin reagent or new coagulation
analyzer.
The intended users of the George King
Coumadin® Plasma are trained laboratory
personnel working in clinical laboratories.	Precision BioLogic CryoCheck INR
Validation Set (K971219)
The Prothrombin Time (PT) was first described
by Quick and is a common method of
monitoring oral anticoagulant treatment in
patients receiving warfarin and related drugs.
In 1983 the World Health Organization (WHO)
described a scheme for PT standardization
based on the Internal Normalized Ratio (INR).
Indicated for use in monitoring the accuracy
and control of oral anticoagulant therapy using
the INR.
Not intended for use as calibration or reference
plasma and should not be used for calibrating
the local International Sensitivity Index (ISI) of
commercial thromboplastins.
Designed to enhance the effective monitoring
of oral anticoagulant therapy

ITEM	DEVICE	PREDICATE
	George King
Coumadin® Plasma	Precision BioLogic CryoCheck INR
Validation Set (K971219)
Product Code	GGN- Plasma, Coagulation Control	GGN- Plasma, Coagulation Control
Test
Principle	$INR = \left(\frac{\text{Patient PT}}{\text{Mean of normal range}}\right)^{\text{ISI}}$	Same
Composition	Human fresh frozen citrated plasma with
no additives	Assumed frozen citrated plasma since
most controls sold by P.B are frozen in
nature.

Differences

ITEM	DEVICE	PREDICATE
Preparation	Collected via plasmapheresis
from individual human donors
stabilized on Coumadin® therapy.	Well characterized warfarinized plasmas
(could not find preparation method)
How Sold	Purchased by individual vials, not
as a “set”.	Packaged as a “set” with varying INR ranges

Has the same indications for use
Same test principle and composition
Demonstrates that the device is as safe and effective as a legally marketed device, and does not raise different questions of safety and effectiveness than the predicate device.

I. Summary of Performance Characteristics

1. Analytical performance

a. Precision

Precision was assessed in-house on 3 different lots of each of 3 INR ranges of GK Coumadin® Plasma on the ACL TOP 500. Precision was evaluated in accordance with CLSI EP05-A2, for 20 days with 2 runs per day and 2 replicates per run for each sample (n=80) using a specific lot of RecombiplasTin 2G.

INR Range: 1.5 – 2.8

Sample Description	Mean Value	n	Within-Run		Between-Run		Between-Day		Total
			SD	CV%	SD	CV%	SD	CV%	SD	CV%
Lot 1	2.33	80	0.04	1.82	0.00	0.00	0.03	1.54	0.05	2.38
Lot 2	2.27	80	0.03	1.75	0.00	0.00	0.03	1.30	0.02	1.30
Lot 3	2.31	80	0.04	1.98	0.00	0.00	0.03	1.32	0.03	1.32

Protime

| Sample Description | Mean
Value | n | Within-Run | | Between-Run | | Between-Day | | Total | |
|--------------------|---------------|----|-------------|-----|-------------|-----|-------------|-----|-------------|-----|
| | | | SD | CV% | SD | CV% | SD | CV% | SD | CV% |
| Lot 1 | 28.2 | 80 | 0.51 / 1.81 | | 0.00 / 0.00 | | 0.44 / 1.56 | | 0.67 / 2.39 | |
| Lot 2 | 27.5 | 80 | 0.48 / 1.76 | | 0.00 / 0.00 | | 0.36 / 1.33 | | 0.61 / 2.21 | |
| Lot 3 | 27.9 | 80 | 0.55 / 1.98 | | 0.00 / 0.00 | | 0.37 / 1.34 | | 0.67 / 2.39 | |

INR Range: 2.9 – 4.0

| Sample Description | Mean
Value | n | Within-Run | | Between-Run | | Between-Day | | Total | |
|--------------------|---------------|----|------------|------|-------------|------|-------------|------|-------|------|
| | | | SD | CV% | SD | CV% | SD | CV% | SD | CV% |
| Lot 1 | 3.25 | 80 | 0.04 | 1.53 | 0.00 | 0.00 | 0.04 | 1.39 | 0.06 | 2.07 |
| Lot 2 | 3.03 | 80 | 0.04 | 1.53 | 0.00 | 0.00 | 0.03 | 1.17 | 0.05 | 1.93 |
| Lot 3 | 2.83 | 80 | 0.03 | 1.28 | 0.00 | 0.00 | 0.03 | 1.05 | 0.04 | 1.66 |

Protime

| Sample Description | Mean
Value | n | Within-Run | | Between-Run | | Between-Day | | Total | |
|--------------------|---------------|----|-------------|-----|-------------|-----|-------------|-----|-------------|-----|
| | | | SD | CV% | SD | CV% | SD | CV% | SD | CV% |
| Lot 1 | 39.3 | 80 | 0.61 / 1.55 | | 0.00 / 0.00 | | 0.56 / 1.41 | | 0.83 / 2.10 | |
| Lot 2 | 36.9 | 80 | 0.58 / 1.57 | | 0.00 / 0.00 | | 0.44 / 1.19 | | 0.73 / 1.97 | |
| Lot 3 | 34.5 | 80 | 0.45 / 1.32 | | 0.00 / 0.00 | | 0.37 / 1.08 | | 0.59 / 1.70 | |

INR Range: > 4.1

Sample Description	Mean Value	n	Within-Run		Between-Run		Between-Day		Total
			SD	CV%	SD	CV%	SD	CV%	SD	CV%
Lot 1	4.66	80	0.05	1.14	0.00	0.00	0.04	1.03	0.07	1.54
Lot 2	6.95	80	0.10	1.46	0.00	0.00	0.05	0.79	0.11	1.66
Lot 3	4.74	80	0.06	1.45	0.00	0.00	0.03	0.75	0.07	1.64

Protime

| Sample Description | Mean
Value | n | Within-Run | | Between-Run | | Between-Day | | Total | |
|--------------------|---------------|----|-------------|-----|-------------|-----|-------------|-----|-------------|-----|
| | | | SD | CV% | SD | CV% | SD | CV% | SD | CV% |
| Lot 1 | 57.2 | 80 | 0.66 / 1.16 | | 0.00 / 0.00 | | 0.61 / 1.07 | | 0.90 / 1.58 | |
| Lot 2 | 86.0 | 80 | 1.28 / 1.49 | | 0.00 / 0.00 | | 0.69 / 0.80 | | 1.46 / 1.69 | |
| Lot 3 | 58.3 | 80 | 0.85 / 1.46 | | 0.00 / 0.00 | | 0.44 / 0.76 | | 0.96 / 1.64 | |

. The results met pre-specified acceptance criteria of CV 4.0

Lot	Mean	n	Repeatability		Between Day		Between Site		Reproducibility
Lot	Mean	n	SD	CV	SD	CV	SD	CV	SD	CV
3750	4.66	75	0.04	0.97	0.11	2.50	0.00	0.00	0.12	2.68
3752	6.94	75	0.08	1.16	0.28	4.09	0.00	0.00	0.29	4.26
3753	4.74	75	0.05	1.10	0.16	3.44	0.00	0.00	0.17	3.61

Protime

			Repeatability		Between Day		Between Site		Reproducibility
Lot	Mean	n	SD	CV	SD	CV	SD	CV	SD	CV
3750	56.9	75	0.55	0.98	1.45	2.55	0.00	0.00	1.56	2.73
3752	85.2	75	0.97	1.14	3.49	4.10	0.52	0.61	3.66	4.30
3755	57.9	75	0.63	1.10	2.04	3.52	0.00	0.00	2.13	3.68

The results met pre-specified acceptance criteria of CV