CRYOCHECK LA CHECK, MODELS CHK25-10 (25 X1.0 ML), CHK80-10 (80 X 1.0 ML)

K990579 · Precision Biologic · GIR · Jul 23, 1999 · Hematology

Device Facts

• Record ID: K990579
• Device Name: CRYOCHECK LA CHECK, MODELS CHK25-10 (25 X1.0 ML), CHK80-10 (80 X 1.0 ML)
• Applicant: Precision Biologic
• Product Code: GIR · Hematology
• Decision Date: Jul 23, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.8950
• Device Class: Class 1

Intended Use

Cryo✓Check™ LA Check™ dilute Russell's Viper Venom Test (dRVVT) reagent is a low concentration phospholipid reagent intended for use as a screening test for the presence of lupus anticoagulants (LA). It may be used in conjunction with CryovCheck™ LA Sure™ (a high concentration phospholipid confirmatory reagent) to establish a ratio (LA Check/LA Sure) useful in discriminating between LA positive and LA negative specimens.

Device Story

Cryo/Check™ LA Check is an in vitro diagnostic reagent utilizing dilute Russell's Viper Venom Test (dRVVT) chemistry. It functions as a low-phospholipid screening test for lupus anticoagulants (LA). Used in clinical laboratories by trained personnel; the reagent is mixed with patient plasma samples. The principle of operation relies on the dRVVT pathway, where the venom directly activates Factor X in the presence of phospholipids and calcium. In the presence of LA, the clotting time is prolonged due to the low phospholipid concentration. Results are interpreted by comparing the screening time against a confirmatory test (LA Sure) to calculate a ratio. This ratio assists clinicians in identifying the presence of LA, which is associated with antiphospholipid syndrome and potential thrombotic risk.

Technological Characteristics

In vitro diagnostic reagent; dilute Russell's Viper Venom Test (dRVVT) chemistry; low phospholipid concentration formulation; liquid reagent format; intended for use with automated or manual coagulation analyzers.

Indications for Use

Indicated for use as a screening test for the presence of lupus anticoagulants (LA) in patient specimens. Used in conjunction with a confirmatory reagent to discriminate between LA positive and LA negative specimens.

Regulatory Classification

Identification

Russell viper venom reagent is a device used to determine the cause of an increase in the prothrombin time.

Reference Devices

• CryoCheck™ LA Sure™

Submission Summary (Full Text)

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JUL 23 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Sandy Morrison Manager, Technical Operations Precision Biologicals Incorporated 900 Windmill Road Unit # 100 Dartmouth. Nova Scotia CANADA B3B 1P7

Re: K990579

> Trade Name: Cryo / Check™ LA Check Regulatory Class: II Product Code: GIR Dated: May 25, 1999 Received: May 26, 1999

Dear Mr. Morrison:

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

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 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 [phone] or [phone], 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: _ K 9905 79

Device Name: Cryo Check™ LA Check

## Indications for Use

Cryo✓Check™ LA Check™ dilute Russell's Viper Venom Test (dRVVT) reagent is a low concentration phospholipid reagent intended for use as a screening test for the presence of lupus anticoagulants (LA). It may be used in conjunction with CryovCheck™ LA Sure™ (a high concentration phospholipid confirmatory reagent) to establish a ratio (LA Check/LA Sure) useful in discriminating between LA positive and LA negative specimens.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | <i>Titu E Madini</i> |
|-----------------------------------------|----------------------|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K990579 |

| Prescription Use | <div> <span style="text-decoration: underline;">✓</span> </div> |
|----------------------|-----------------------------------------------------------------|
| (Per 21 CFR 801.109) | |

OR

| Over-The-Counter Use | <div> <span style="text-decoration: underline;">_</span> </div> |
|--------------------------|-----------------------------------------------------------------|
| (Optional Format 1-2-96) | |