GradiPlasma LA High is a high positive control plasma for use in Lupus Anticoagulant clotting test assays, specifically LA SCREEN (DRVVT) and LA CONFIRM (DRVVT) from Gradipore. GradiPlasma LA Low is a low positive control plasma for use in Lupus Anticoagulant clotting test assays, specifically LA SCREEN (DRVVT) and LA CONFIRM (DRVVT) from Gradipore.

Device Description

GradiPlasma LA High and Low are preparations of fresh human citrated plasma with added buffers and stabilizers, for in vitro diagnostic use. The controls are prepared from patients diagnosed with Lupus Anticoagulant and lyophilized in two levels (High and Low) and two volumes (0.5ml and 1.0ml).

AI/ML Overview

The provided document describes the GradiPlasma LA High and Low, which are Lupus Anticoagulant Quality Control Plasmas. The FDA determined the device to be substantially equivalent to a predicate device, Verify® LA Control (K961370).

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

1. Table of Acceptance Criteria and Reported Device Performance:

The primary acceptance criteria appear to be related to the within-run variance of the control plasmas, demonstrating similar performance to the predicate device and being below a specified threshold. Stability after reconstitution and single freeze-thaw were also criteria.

Acceptance Criteria	Reported Device Performance (GradiPlasma LA)
Within-run %CV for LA SCREEN (DRVVT)	High: 1.7%Low: 0.8%Predicate (Verify® LA): 0.8%
Within-run %CV for LA CONFIRM (DRVVT)	High: 1.4%Low: 0.9%Predicate (Verify® LA): 2.3%
Target Specification for Within-run %CV	Well below 5%
Reconstituted Stability	Stable for 8 hours at 2-8℃ (using Dade Behring BCT analyzer)
Freeze-thaw Stability	Able to be freeze-thawed once (using Dade Behring BCT analyzer)
Equivalence to Predicate Device (Overall)	Demonstrated overall performance characteristics, intended use, safety, and effectiveness similar to Verify® LA Control. (Conclusion stated in document)

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

Sample Size for Test Set: The document does not explicitly state the numerical sample sizes (e.g., number of runs, number of replicates, or distinct patient samples) used for the comparative performance study. It mentions "a comparative performance study."
Data Provenance: The studies were performed using IL ACL300, IL MLA 800, and Dade Behring BCT instruments. The submitter is Gradipore Ltd, Australia, suggesting the data likely originates from Australia. The study appears to be prospective in nature, as it describes the testing of the new device against the predicate.

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

This information is not provided in the document. The study focuses on the performance of control plasmas in laboratory assays rather than on diagnostic interpretations by experts. The "ground truth" for these control plasmas is their known positive status for Lupus Anticoagulant, established during their preparation from diagnosed patients.

4. Adjudication method for the test set:

This information is not applicable and not provided. The study involves objective measurements from laboratory instruments, not human interpretation that would require adjudication.

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:

This information is not applicable and not provided. This device is an in-vitro diagnostic control plasma, not an AI-powered diagnostic tool requiring human reader studies.

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

This information is not applicable and not provided. This is not an algorithmic device; it is a laboratory reagent.

7. The type of ground truth used:

The ground truth for the GradiPlasma LA controls is their known status as positive for Lupus Anticoagulant (High and Low levels), derived from patients diagnosed with Lupus Anticoagulant. This is an inherent property of the control material, established during its manufacturing process.

8. The sample size for the training set:

This information is not provided and not applicable in the context of this device. It is a control plasma, not a machine learning algorithm that requires a training set. The "training" for such a device would be its manufacturing and characterization process.

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

This information is not provided and not applicable for the same reasons as #8. The ground truth (known positive LA status) is established during the selection of plasma from diagnosed patients for manufacturing.

Summary

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FEB 16 2000

K9933332

GRADIPLASMA LA HIGH AND LOW PREMARKET NOTIFICATION 510(K) SUMMARY (Summary of Safety and Effectiveness)

Submitter:	Rhonda PilgrimRegulatory Affairs ManagerGradipore LtdLot 16 Riverside Corporate Park35 - 105 Delhi Rd, North Ryde 2113Australia1800 762 2620Fax (612) 9805 0624
Contact Person:	Rhonda Pilgrim1800 762 2620
Date Prepared:	January 17, 2000
Trade Name:	GradiPlasma LA High and Low
Common or Usual Name:	Lupus Anticoagulant Quality Control Plasmas
Classification Name:	Control, Plasma, AbnormalPer 21CFR section 864.7925, Class II
Equivalent Device:	Verify® LA Control, K961370

Description of the device / intended use:

Validation studies for the GradiPlasma LA High and GradiPlasma LA Low have been performed using IL ACL300, IL MLA 800 and Dade Behring BCT instruments.

Image /page/0/Picture/8 description: The image shows the words "Gradipore" and "ORIGINAL" stacked on top of each other. Below that, the words "(if in red)" are written. The text appears to be part of a document or label, possibly indicating the authenticity or original status of a product.

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510(k) Premarket Notification - Additional Information Gradipore LTD GradiPlasma LA High and Low K993332

Statement of how the technological characteristics of the Device compare to the predicate device

GradiPlasma LA High and Low were compared against Organon Teknika's Verify® LA Control, a 510(k) cleared device. Both devices are unassayed in vitro diagnostic controls prepared by lyophilization of known positive lupus anticoagulant patients, with added buffers and stabilizers. Both controls are intended for use in dilute Russell's Viper Venom Time test systems such as LA SCREEN (DRVVT) with phospholipid neutralization tests such as LA CONFIRM (DRVVT). The Verify® LA Control is a single level control whereas the GradiPlasma LA has both a high and low level. Each level of GradiPlasma LA is available in 10 X 0.5ml and 10 X 1.0ml volumes while the Verify® LA Control is available only in 10 X 0.5ml.

Summary of Performance Data

In a comparative performance study on an IL MLA800 instrument, the GradiPlasma LA High and GradiPlasma LA Low exhibited similar within-run variance to the predicate device, Verify® LA Control. Within-run %CV for both levels of GradiPlasma was well below specifications (5%). GradiPlasma LA High gave 1.7% CV with LA SCREEN and 1.4% with LA CONFIRM; GradiPlasma LA Low gave 0.8% with LA SCREEN and 0.9% with LA CONFIRM, while the predicate Verify® LA Control gave 0.8% with LA SCREEN and 2.3% with LA CONFIRM.

In a study comparing reconstituted stability of the devices using a Dade Behring BCT analyzer the GradiPlasma LA High and Low were stable for 8 hours at 2-8℃ and were able to be freeze thawed once. The Verify® LA was also stable for 8 hours at 2-8°C.

Conclusion

Based on the data provided, Gradipore concludes that GradiPlasma LA High and Low are substantially equivalent to the predicate device, Verify® LA Control in overall performance characteristics, intended use, safety and effectiveness. The one new performance characteristic of the GradiPlasma LA, (two levels of control), is designed to provide a more comprehensive set of controls for lupus anticoagulant testing.

Gradipore
ORIGINAL
(if in red)

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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, serif font. The text is centered in the image and is the only element present.

FEB 1 6 2000

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Rhonda Pilgrim Regulatory Affairs Manager Gradipore Limited Lot 16 Riverside Corporate Park 35-105 Delhi Road, North Ryde 2113 AUSTRALIA

Re: K993332 Trade Name: GradiPlasma LA High and Low Regulatory Class: II Product Code: GGC Dated: January 17, 2000 Received: January 19, 2000

Dear Ms. Pilgrim:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2

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, permits 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" (21CFR 807.97). Other general 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 Butman

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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INTENDED USE STATEMENT

510(k) Number (If known): 993332

Device Names: GradiPlasma LA-High and GradiPlasma LA - Low

Indications For Use:

GradiPlasma LA High is a high positive control plasma for use in Lupus Anticoagulant clotting test assays, specifically LA SCREEN (DRVVT) and LA CONFIRM (DRVVT) from Gradipore.

GradiPlasma LA Low is a low positive control plasma for use in Lupus Anticoagulant clotting test assays, specifically LA SCREEN (DRVVT) and LA CONFIRM (DRVVT) from Gradipore.

Validation studies for the GradiPlasma LA High and GradiPlasma LA Low have been performed using IL ACL300, IL MLA 800 and Dade Behring BCT instruments.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number	K993332
Prescription Use
(Per 21 CFR 801.109)
OR	Over-The-Counter Use
	(Optional Format 1-2-96)

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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.