CRYO CHECK FACTOR XII DEFICIENT PLASMA MODEL FDP12-10 (1.0ML) AND FDP12-15 (1.5ML)

K981174 · Precision Biologicals, Inc. · GJT · Jan 13, 1999 · Hematology

Device Facts

• Record ID: K981174
• Device Name: CRYO CHECK FACTOR XII DEFICIENT PLASMA MODEL FDP12-10 (1.0ML) AND FDP12-15 (1.5ML)
• Applicant: Precision Biologicals, Inc.
• Product Code: GJT · Hematology
• Decision Date: Jan 13, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7290
• Device Class: Class 2

Intended Use

CryovCheck™ Factor XII Deficient Plasma is recommended for use as a substrate in clot-based Factor XII assays using the activated partial thromboplastin time (APTT) assay.

Device Story

Cryo✓Check™ Factor XII Deficient Plasma is a frozen human plasma product used as a substrate in clinical laboratory coagulation testing. It is prepared from citrated pooled normal human plasma depleted of Factor XII via immunoadsorption. The device is intended for use by laboratory professionals to perform clot-based Factor XII assays using the activated partial thromboplastin time (APTT) method. By providing a substrate with <1% Factor XII activity and >50% activity for all other coagulation factors, it enables the quantification of Factor XII levels in patient samples. The product is supplied frozen and requires thawing before use in the laboratory setting.

Clinical Evidence

Bench testing only. Open vial stability study performed comparing Factor XII recovery at 0 and 24 hours using a known reference plasma. Results showed mean recovery of 92.8% at 0 hours and 93% at 24 hours, supporting an 8-hour open vial stability claim.

Technological Characteristics

Frozen human plasma; Factor XII depleted via immunoadsorption; Factor XII activity <1%; other coagulation factors >50%.

Indications for Use

Indicated for use as a substrate in clot-based Factor XII assays using the activated partial thromboplastin time (APTT) assay for clinical laboratory testing.

Predicate Devices

• Factor XII Deficient Plasma (K900412)

Submission Summary (Full Text)

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JAN 1 3 1999

K981174

## 510(k) Summary for Cryo✓Check™ Factor XII Deficient Plasma

- Submitter's Address and Contact Information 1.
- Precision Biologicals Incorporated a) 900 Windmill Rd. Unit # 100 Dartmouth, Nova Scotia Canada B3B 1P7
- b) Contact

Mr. Sandy Morrison Manager, Technical Operations Phone: [phone] [phone] Fax: E-mail: [e-mail]

- Date Prepared: March 10, 1998 c)
- Device Name 2.

| a) | Proprietary (trade) name: | Cryo✓Check™ Factor XII Deficient Plasma |
|----|-----------------------------|------------------------------------------------------------------|
| b) | Common name: | Factor 12 Deficient Plasma (human) |
| c) | Classification name: | Coagulation Factor Deficient Plasma |
| d) | Classification information: | Regulatory Class II<br>Hematology Panel<br>Product Code - 81 GJT |

## 3. Device Description:

Cryo✓Check™ Factor XII Deficient Plasma is frozen human plasma deficient in the Factor XII coagulation factor. It is prepared from citrated pooled normal human plasma which has been depleted of Factor XII by immunoadsorption. Activity levels of Factor XII are assayed at less than 1% normal levels while all other coagulation factors are greater than 50%.

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## Intended Use 4.

CryovCheck™ Factor XII Deficient Plasma is recommended for use as a substrate in clot-based Factor XII assays using the activated partial thromboplastin time (APTT) assay.

- Substantially Equivalent Device 5.
- 510(k) number: K900412 a)
- Trade Name: Factor XII Deficient Plasma b)
- Manufacturer: Sigma c)
- d) Substantial Equivalence Comparison

Cryo Check™ Factor XII Deficient Plasma is similar to the predicate device in that they both have the same "indications for use"; target population; and are both made from human plasma.

Cryo Check™ Factor XII Deficient Plasma differs from the predicate device in that it is a frozen liquid preparation and not a lyophillized Additionally, Cryo Check™ Factor XII Deficient Plasma is product. prepared from normal human plasma from which Factor XII has been immunoadsorbed, while the predicate device is derived from human donors with a congenital Factor XII deficiency.

To our knowledge, these differences do not affect the intended use or performance of the device.

- Non-Clinical Performance Data 24 Hour Open Vial Stability : 6.
- a) Testing Performed:
- i) Factor XII assays were performed on a known reference plasma using vials of Cryor Check™ Factor XII Deficient Plasma as a substrate. Recovered factor XII values were measured at 0 hours and 24 hours. (see table for results)
- b) Conclusions:

Test results indicate that a claim of 8 hours open vial stability is acceptable.

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| Table S1 | | | |
|-------------------------------------------------------------------------------------------|---------|----------|---------|
| Open Vial Stability of Cryo <span style="font-family: Arial, sans-serif;">✓</span> Check™ | | | |
| Factor XII Deficient Plasma | | | |
| Summary Statistics (% Recovery) | | | |
| | 0 Hours | 24 Hours | Average |
| MEAN | 92.8 | 93 | 92.9 |
| MAXIMUM | 96 | 97 | 97 |
| MINIMUM | 90 | 89 | 89 |
| S.D. | 2.17 | 3.16 | 2.56 |
| 2 S.D. | 4.34 | 6.32 | 5.12 |
| SAMPLE SIZE | 5 | 5 | 10 |
| C.V.% | 2.34 | 3.4 | 2.75 |

## Note: Reference Value =

Acceptable values are: Mean (+/-) 5% of reference value; and %C.V. < 5%