(212 days)
Not Found
No
The summary describes a reagent used in a laboratory procedure and does not mention any computational or algorithmic components, let alone AI/ML.
No
The device is intended for detecting lupus anticoagulants in human plasma, which is a diagnostic purpose, not a therapeutic one.
Yes
Explanation: The device is intended "for use in the Platelet Neutralization Procedure (PNP) which is useful in detecting the presence of lupus anticoagulants (LA) in human plasma." This directly indicates its use in identifying a medical condition, which is the definition of a diagnostic device.
No
The device description clearly states it is a "suspension of ruptured platelet membranes" prepared from human platelets, indicating it is a biological reagent, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is "intended for use in the Platelet Neutralization Procedure (PNP) which is useful in detecting the presence of lupus anticoagulants (LA) in human plasma." This indicates it is used to test human samples (plasma) in vitro (outside the body) to provide diagnostic information (detecting lupus anticoagulants).
- Device Description: The description details a reagent prepared from human platelets for use in a laboratory procedure.
- Performance Studies: The document describes performance studies involving testing with human plasma samples (normal and lupus anticoagulant positive) to evaluate the device's performance in the intended diagnostic procedure.
These characteristics align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Cryo✓Check™ PNP Platelet Lysate is intended for use in the Platelet Neutralization Procedure (PNP) which is useful in detecting the presence of lupus anticoagulants (LA) in human plasma.
Product codes (comma separated list FDA assigned to the subject device)
81 GIT, GGW
Device Description
Cryo Check™ PNP Platelet Lysate is prepared from human platelets obtained from normal healthy donors. The platelets are collected, washed, and resuspended in buffer and then frozen and thawed to yield a suspension of ruptured platelet membranes. This suspension is aliquoted into cryovials and stored frozen.
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
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non Clinical Performance Data:
-
Tests Performed
- PNP’s of normal and known lupus anticoagulant positive patient samples comparing the performance of Cryo Check™ PNP Platelet Lysate to the predicate device (see Table V-1).
- 8 hour open vial stability study to demonstrate consistent vial to vial PNP results with normal plasma and lupus anticoagulant positive plasma (see Table V-2).
- 14 hour open vial stability on an MDA-180 automated coagulation analyzer (see Table V-3).
- Comparison of PNP’s of LA negative patient samples using Cryov Check™ PNP Platelet Lysate on two different automated coagulation analyzer systems: 1. MDA-180 using a photo-optical clot detection system: 2. Stago ST4 using a mechanical clot detection system (see Table V-3).
-
Conclusions
- CryovCheck™ PNP Platelet Lysate demonstrated comparable specificity to the predicate device when tested against normal plasma and lupus anticoagulant positive patient plasmas when used in a platelet neutralization procedure.
- PNP procedures using Cryo Check™ PNP Platelet Lysate exhibited consistent vial to vial reactivity over an 8-hour period.
- Cryov Check™ PNP Platelet Lysate is stable for greater than 8 hours on an MDA 180 automated coagulation analyzer.
- Cryov Check™ PNP Platelet Lysate yielded consistent results when used on 2 different automated coagulation systems.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Specificity (when tested against normal plasma and lupus anticoagulant positive patient plasmas).
Table V-1: Comparison of Cryo Check PNP Platelet Lysate to BIO/DATA Platelet Extract Reagent.
- PNP Procedures, Instrument: Diagnostica Stago ST4, Reagent: Organon Teknika Automated APTT Lot# 161152.
- Normal Samples (n=5):
- Cryo Check PNP Platelet Lysate mean correction: 0.34 sec.
- BIO/DATA Platelet Extract mean correction: -0.6 sec.
- Correlation coefficient: -0.510.
- Lupus Samples (n=10):
- Cryo Check PNP Platelet Lysate mean correction: 15.72 sec.
- BIO/DATA Platelet Extract mean correction: 14.56 sec.
- Correlation coefficient: 0.987.
Table V-2: 8 Hour Open Vial Stability Study.
- System Information: Analyzer: MLA 900 C, APTT Reagent: Dade Actin FSL (Lot#: FSL164A), Normal Plasma: Cryo ✓ Check™ Normal (CCN) (Lot #: 1600), Lupus Plasma: Cryo ✓ Check™ Lupus (CCLP) (Lot#: 6100), Platelets: Cryo ✓ Check™ PNP Platelet Lysate (PNP) (Lot#: PL01).
- Test Results:
- Normal Plasma:
- Time = 0 hrs: Mean Correction = 4.7 sec (SD = 0.292)
- Time = 8 hrs: Mean Correction = 3.84 sec (SD = 0.358)
- Lupus Plasma:
- Time = 0 hrs: Mean Correction = 12.6 sec (SD = 1.39)
- Time = 8 hrs: Mean Correction = 11.0 sec (SD = 0.358)
- Normal Plasma:
Table V-3: ON BOARD STABILITY STUDY CryoCheck PNP Platelet Lysate.
- Instrument: MDA 180, Reagent: Platelin-L Lot #: 161132
- Precision Biologicals Normal Control: CCN-10 lot# 1580; expires Mar.'00 (n=17 time points)
- Mean Neutralization: -4.14 sec (Std. Dev.: 0.291)
- Precision Biologicals Lupus Positive Control:CCLP-10 lot# 6100; expires Sept.'00 (n=17 time points)
- Mean Neutralization: 17.2 sec (Std. Dev.: 0.819)
- HRF "in-house" positive control (n=17 time points)
- Mean Neutralization: 29.8 sec (Std. Dev.: 1.055)
Table V-4: Cryo Check PNP Platelet Lysate Comparison of Reactivity on 2 Automated Coagulation Analyzers With Normal Patient Samples.
- Instrument: MDA 180 (Photo-Optical Clot Detection) (n=25 samples)
- Mean neutralization: -2.084 sec (std dev: 1.051)
- Instrument: ST4 (Mechanical Clot Detection) (n=25 samples)
- Mean neutralization: -3.664 sec (std dev: 1.151)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 864.7925 Partial thromboplastin time tests.
(a)
Identification. A partial thromboplastin time test is a device used for primary screening for coagulation abnormalities, for evaluation of the effect of therapy on procoagulant disorders, and as an assay for coagulation factor deficiencies of the intrinsic coagulation pathway.(b)
Classification. Class II (performance standards).
0
JAN 1 3 1999
Image /page/0/Picture/1 description: The image is a black and white photograph. The image is mostly white, with a few black spots scattered throughout. The black spots are small and irregular in shape. The spots are concentrated in the lower half of the image, with a few scattered in the upper half.
510(k) Summary for Cryo✓Check™ PNP Platelet Lysate
-
- Submitter's Address and Contact Information
- a) Company Address
Precision BioLogic Incorporated 900 Windmill Rd. Unit # 100 Dartmouth, Nova Scotia Canada B3B 1P7
-
b) Contact
Mr. Sandy Morrison Manager, Technical Operations Phone: (902) 468-6422 Fax: (902) 468-6421 E-mail: smorrison@precisionbiologic.com -
c) Date Prepared:
June 5, 1998 -
- Device Name
- Proprietary (trade) name: Cryov Check™ PNP Platelet Lysate a)
- b) Common name: Platelet Extract (human)
- Classification name: Partial Thromboplastin Time, Reagents, Controls c)
- d) Classification information : Regulatory Class II Hematology Panel Product Code - 81 GIT
Device Description 3.
- a)
Cryo Check™ PNP Platelet Lysate is prepared from human platelets obtained from normal healthy donors. The platelets are collected, washed,
V - 1
1
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and resuspended in buffer and then frozen and thawed to yield a suspension of ruptured platelet membranes. This suspension is aliquoted into cryovials and stored frozen.
Intended Use 4.
Cryo Check™ PNP Platelet Lysate is intended for use in the Platelet Neutralization Procedure (PNP). The PNP is useful in detecting the presence of lupus anticoagulants in human plasma.
-
- Substantially Equivalent Device
- 510(k) number: K873382 a)
- Trade Name: Platelet Extract Reagent b)
- Manufacturer: BIO/DATA Corporation c)
- d) Substantial Equivalence Comparison
Cryo Check™ PNP Platelet Lysate is similar to the equivalent device in that they are both intended for use in the PNP for detecting the presence of lupus anticoagulants; have the same target population; and are both made from human platelets.
Cryo Check™ PNP Platelet Lysate differs from the equivalent device in that it is a frozen liquid preparation and not a lyophilized product.
To our knowledge, this difference does not affect the intended use or performance of the device.
-
- Non Clinical Performance Data
- Tests Performed a)
- i) PNP's of normal and known lupus anticoagulant positive patient samples comparing the performance of Cryo Check™ PNP Platelet Lysate to the predicate device (see Table V-1)
- ii) 8 hour open vial stability study to demonstrate consistent vial to vial PNP results with normal plasma and lupus anticoagulant positive plasma (see Table V-2)
- iii) 14 hour open vial stability on an MDA-180 automated coagulation analyzer (see Table V-3)
2
Image /page/2/Picture/0 description: The image shows a white background with several black spots scattered across it. The spots vary in size and shape, with some appearing as small dots and others as larger, irregular blotches. The distribution of the spots is somewhat random, with no apparent pattern or clustering.
- iv) Comparison of PNP's of LA negative patient samples using Cryov Check™ PNP Platelet Lysate on two different automated coagulation analyzer systems: 1. MDA-180 using a photo-optical clot detection system: 2. Stago ST4 using a mechanical clot detection system (see Table V-3)
b) Conclusions
- CryovCheck™ PNP Platelet Lysate demonstrated comparable i) specificity to the predicate device when tested against normal plasma and lupus anticoagulant positive patient plasmas when used in a platelet neutralization procedure.
- PNP procedures using Cryo Check™ PNP Platelet Lysate exhibited ii) consistent vial to vial reactivity over an 8-hour period.
- Cryov Check™ PNP Platelet Lysate is stable for greater than 8 iii) hours on an MDA 180 automated coagulation analyzer.
- Cryov Check™ PNP Platelet Lysate yielded consistent results iv) when used on 2 different automated coagulation systems.
3
Image /page/3/Picture/0 description: The image shows a scattering of small, dark, irregular shapes against a bright white background. The shapes are distributed somewhat sparsely across the frame, with no apparent pattern or organization. The contrast between the dark shapes and the white background is high, making the shapes stand out clearly.
Table V-1
Comparison of Cryo Check PNP Platelet Lysate to BIO/DATA Platelet Extract Reagent
Procedure: Platelet Neutralization Procedure Instrument: Diagnostica Stago ST4 Organon Teknika Automated APTT Lot# 161152 Reagent:
| Saline | Cryo | |||
|---|---|---|---|---|
| Dilution | BIO/DATA | Check | ||
| Baseline | 50:50 | PNP | PNP | |
| APTT | APTT | correction | correction | |
| Sample | (sec.) | (sec.) | (sec.) | (sec.) |
| Normal 1 | 31.4 | 35.8 | -2.0 | 0.6 |
| Normal 2 | 28.7 | 30.4 | 0.4 | -0.9 |
| Normal 3 | 32.6 | 32.3 | -0.5 | 0.1 |
| Normal 4 | 30.5 | 35.4 | -0.4 | 0.9 |
| Normal 5 | 31.9 | 34.7 | -0.4 | 1.0 |
| Lupus 1 | 75.6 | 63.1 | 22.7 | 22.1 |
| Lupus 2 | 55.8 | 43.6 | 7.1 | 6.1 |
| Lupus 3 | 51.7 | 40.9 | 7.6 | 4.5 |
| Lupus 4 | 103.8 | 89.6 | 40.6 | 44.5 |
| Lupus 5 | 62.5 | 49.4 | 6.5 | 7.3 |
| Lupus 6 | 53.7 | 47 | 5.7 | 6.6 |
| Lupus 7 | 47.1 | 41.2 | 4.5 | 3.4 |
| Lupus 8 | 80.5 | 70 | 23.8 | 28.9 |
| Lupus 9 | 64.7 | 57.7 | 15.3 | 19.5 |
| Lupus 10 | 73.3 | 59.2 | 11.8 | 14.3 |
| summary - | |||
|---|---|---|---|
| PNP's of normal plasmas | PNP's of Lupus plasmas | ||
| Cryo | |||
| Check | |||
| PNP | |||
| Platelet | |||
| Lysate | BIO/DATA | ||
| Platelet | |||
| Extract | Cryo | ||
| Check | |||
| PNP | |||
| Platelet | |||
| Lysate | BIO/DATA | ||
| Platelet | |||
| Extract | |||
| mean 0.34 | -0.6 | mean 15.72 | 14.56 |
| correlation coefficient* -0.510 | correlation coefficient 0.987 |
*The low correlation coefficient with the normal samples is attributed to the short correction time values and does not indicate that either product is defective.
V - 4
4
Table V-2
8 Hour Open Vial Stability Study
System Information:
-
- Analyzer: MLA 900 C
| 2. APTT Reagent: Dade Actin FSL | Lot#: FSL164A | Expiry: Feb., 1999 |
|---|---|---|
| 3. Normal Plasma: Cryo ✓ Check™ Normal (CCN) | Lot #: 1600 | Expiry: April, 2000 |
| 4. Lupus Plasma: Cryo ✓ Check™ Lupus (CCLP) | Lot#: 6100 | Expiry: Sept., 2000 |
| 5. Platelets: Cryo ✓ Check™ PNP Platelet Lysate (PNP) | Lot#: PL01 | Expiry: April, 2000 |
Test Method:
-
- Baseline APTT's determined for normal plasma and lupus anticoagulant positive plasma
-
- APTT's determined for 1:1 mixture of above plasmas diluted with saline
-
- APTT's determined for 1:1 mixture of above plasmas with PNP Platelet Lysate
-
- Corrections calculated by subtracting the time in seconds of the plasma : platelet lysate mixture from the time in seconds of the plasma : saline mixture
Test Results:
| Time = 0 hrs | Time = 8 hrs | |||||||
|---|---|---|---|---|---|---|---|---|
| Normal Plasma | Lupus Plasma | Normal Plasma | Lupus Plasma | |||||
| APTT | ||||||||
| (seconds) | Correction | |||||||
| (seconds) | APTT | |||||||
| (seconds) | Correction | |||||||
| (seconds) | APTT | |||||||
| (seconds) | Correction | |||||||
| (seconds) | APTT | |||||||
| (seconds) | Correction | |||||||
| (seconds) | ||||||||
| Baseline | 28.3 | N/A | 59.8 | N/A | 27.6 | N/A | 58.3 | N/A |
| Saline | 42.3 | N/A | 54.2 | N/A | 40.3 | N/A | 53.4 | N/A |
| PNP Vial 1 | 37.2 | 5.1 | 39.3 | 14.9 | 36.4 | 3.9 | 42.9 | 10.5 |
| PNP Vial 2 | 37.5 | 4.8 | 43.0 | 11.2 | 37.0 | 3.3 | 42.7 | 10.7 |
| PNP Vial 3 | 38.0 | 4.3 | 41.4 | 12.8 | 36.5 | 3.8 | 42.1 | 11.3 |
| PNP Vial 4 | 37.6 | 4.7 | 41.9 | 12.3 | 36.4 | 3.9 | 42.1 | 11.3 |
| PNP Vial 5 | 37.7 | 4.6 | 42.2 | 12.0 | 36.0 | 4.3 | 42.4 | 11.0 |
| Mean | 4.7 | Mean | 12.6 | Mean | 3.84 | Mean | 11.0 | |
| SD | 0.292 | SD | 1.39 | SD | 0.358 | SD | 0.358 |
5
... .. .. . Table Ữ - 3
ﮨﮯ
ON BOARD STABILITY STUDY CryoCheck PNP Platelet Lysate
| Instrument: MDA 180 | Reagent: Platelin-L
Lot #: 161132 | | | |
|-------------------------------------------------------------------------|--------------------------------------|-------------|----------|----------------|
| Precision Biologicals Normal Control: CCN-10 lot# 1580; expires Mar.'00 | | | | |
| | | saline/1580 | PNP/1580 | Neutralization |
| test time | | seconds | seconds | seconds |
| 0 min | | 22.7 | 27.3 | -4.6 |
| 30 min | | 22.6 | 27.2 | -4.6 |
| 45 min | | 22.7 | 27 | -4.3 |
| 1 hr | | 22.8 | 27.2 | -4.4 |
| 2 hr | | 23.2 | 26.9 | -3.7 |
| 3 hr | | 23.0 | 27.2 | -4.2 |
| 4 hr | | 23.3 | 26.9 | -3.6 |
| 5 hr | | 23.0 | 27.2 | -4.2 |
| 6 hr | | 23.2 | 27 | -3.8 |
| 7 hr | | 23.1 | 27.3 | -4.2 |
| 8 hr | | 23.1 | 27.5 | -4.4 |
| 9 hr | | 23.6 | 27.5 | -3.9 |
| 10 hr | | 23.6 | 27.9 | -4.3 |
| 11 hr | | 23.8 | 27.8 | -4 |
| 12 hr | | 23.6 | 27.7 | -4.1 |
| 13 hr | | 23.9 | 28 | -4.1 |
| 14 hr | | 23.9 | 27.8 | -3.9 |
| | mean | 23.2 | 27.4 | -4.14 |
| | Std. Dev. | 0.427 | 0.356 | 0.291 |
| Precision Biologicals Lupus Positive Control:CCLP-10 lot# 6100; expires Sept.'00 | ||||
|---|---|---|---|---|
| saline/6100 | PNP/6100 | Neutralization | ||
| test time | seconds | seconds | seconds | |
| 0 min | 54.8 | 37.5 | 17.3 | |
| 30 min | 54.1 | 37.2 | 16.9 | |
| 45 min | 54.6 | 37.2 | 17.4 | |
| 1 hr | 54.7 | 37.7 | 17 | |
| 2 hr | 54.5 | 37.4 | 17.1 | |
| 3 hr | 55.5 | 37.4 | 18.1 | |
| 4 hr | 55 | 37.1 | 17.9 | |
| 5 hr | 53.3 | 37.6 | 15.7 | |
| 6 hr | 55.4 | 37.7 | 17.7 | |
| 7 hr | 56.5 | 38.3 | 18.2 | |
| 8 hr | 55.6 | 38.1 | 17.5 | |
| 9 hr | 55.1 | 37.9 | 17.2 | |
| 10 hr | 55.2 | 38.7 | 16.5 | |
| 11 hr | 54.9 | 38.5 | 16.4 | |
| 12 hr | 55 | 38.8 | 16.2 | |
| 13 hr | 54.8 | 38.4 | 16.4 | |
| 14 hr | 57.4 | 38.5 | 18.9 | |
| mean | 55.1 | 37.9 | 17.2 | |
| Std. Dev. | 0.902 | 0.563 | 0.819 |
| HRF "in-house" positive control | ||||
|---|---|---|---|---|
| test time | saline/HRF | |||
| seconds | PNP/HRF | |||
| seconds | Neutralization | |||
| seconds | ||||
| 0 min | 69.6 | 41.3 | 28.3 | |
| 30 min | 70 | 41.8 | 28.2 | |
| 45 min | 70.4 | 41.5 | 28.9 | |
| 1 hr | 70.1 | 41.1 | 29 | |
| 2 hr | 72.1 | 42.2 | 29.9 | |
| 3 hr | 72.2 | 42.7 | 29.5 | |
| 4 hr | 72.2 | 42.9 | 29.3 | |
| 5 hr | 70.5 | 42.1 | 28.4 | |
| 6 hr | 71.5 | 42.4 | 29.1 | |
| 7 hr | 74.3 | 43.8 | 30.5 | |
| 8 hr | 74.6 | 44.7 | 29.9 | |
| 9 hr | 75.2 | 45.1 | 30.1 | |
| 10 hr | 76.1 | 45.5 | 30.6 | |
| 11 hr | 76.8 | 45.8 | 31 | |
| 12 hr | 75.9 | 45.7 | 30.2 | |
| 13 hr | 77.9 | 46.1 | 31.8 | |
| 14 hr | 77.9 | 46.7 | 31.2 | |
| mean | 73.4 | 43.6 | 29.8 | |
| std. Dev. | 2.889 | 1.910 | 1.055 |
V - 6
6
Image /page/6/Picture/0 description: The image shows a scatter plot of points. There are nine points in total, scattered across the image. The points are arranged in a somewhat irregular pattern, with some points clustered together and others more isolated.
Table V -4
Cryo Check PNP Platelet Lysate Comparison of Reactivity on 2 Automated Coagulation Analyzers With Normal Patient Samples
Instrument: MDA 180 Type: Photo-Optical Clot Detection Instrument: ST4 Type: Mechanical Clot Detection
| Sample # | 50:50 | 50:50 | ||||
|---|---|---|---|---|---|---|
| Sal./Sample | ||||||
| APTT (sec.) | PL/Sample | |||||
| APTT (sec.) | neutraliz. | |||||
| (sec.) | Sal./Sample | |||||
| APTT (sec.) | PL/Sample | |||||
| APTT (sec.) | neutraliz. | |||||
| (sec.) | ||||||
| 1 | 23.1 | 25.6 | -2.5 | 23.0 | 25.7 | -2.7 |
| 2 | 18.8 | 19.7 | -0.9 | 29.2 | 32.7 | -3.5 |
| 3 | 25.2 | 26.3 | -1.1 | 31.2 | 33.6 | -2.4 |
| 4 | 24.4 | 27.6 | -3.2 | 30.1 | 34.7 | -4.6 |
| 5 | 25.1 | 27.2 | -2.1 | 28.4 | 33.7 | -5.3 |
| 6 | 22.0 | 23.8 | -1.8 | 27.4 | 31.1 | -3.7 |
| 7 | 32.4 | 34.9 | -2.5 | 37.8 | 42.4 | -4.6 |
| 8 | 23.7 | 26.1 | -2.4 | 28.9 | 33.8 | -4.9 |
| 9 | 21.2 | 23.7 | -2.5 | 27.5 | 31.9 | -4.4 |
| 10 | 24.1 | 24.7 | -0.6 | 30.1 | 33.0 | -2.9 |
| 11 | 21.2 | 23.1 | -1.9 | 26.3 | 30.6 | -4.3 |
| 12 | 26.3 | 25.9 | 0.4 | 27.7 | 32.7 | -5 |
| 13 | 24.7 | 28.1 | -3.4 | 34.0 | 34.7 | -0.7 |
| 14 | 22.7 | 25.8 | -3.1 | 31.8 | 35.9 | -4.1 |
| 15 | 24.7 | 27.6 | -2.9 | 32.5 | 37.1 | -4.6 |
| 16 | 19.2 | 21.9 | -2.7 | 24.8 | 27.8 | -3 |
| 17 | 30.9 | 33.2 | -2.3 | 37.7 | 42.2 | -4.5 |
| 18 | 20.6 | 24.2 | -3.6 | 27.2 | 31.1 | -3.9 |
| 19 | 23.9 | 25.1 | -1.2 | 28.8 | 31.7 | -2.9 |
| 20 | 18.3 | 20.7 | -2.4 | 24.1 | 27 | -2.9 |
| 21 | 24.7 | 26.9 | -2.2 | 29.1 | 33.1 | -4 |
| 22 | 24.6 | 25.5 | -0.9 | 31.0 | 32.4 | -1.4 |
| 23 | 23.7 | 24.0 | -0.3 | 28.9 | 31.4 | -2.5 |
| 24 | 19.9 | 22.4 | -2.5 | 25.1 | 29.7 | -4.6 |
| 25 | 22.9 | 26.4 | -3.5 | 29.7 | 33.9 | -4.2 |
| mean | -2.084 | mean | -3.664 | |||
| std dev | 1.051 | std dev | 1.151 |
7
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 1 3 1999
Mr. Sandy Morrison Manager, Technical Operations Precision BioLogic Incorporated 900 Windmill Road Unit # 100 Dartmouth, Nova Scotia CANADA B3B 1P7
Re: K982062
Trade Name: Cryo Check™ PNP Platelet Lysate Regulatory Class: II Product Code: GGW Dated: June 5, 1998 Received: June 15, 1998
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.
8
Page 2
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 (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, 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"(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 (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
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
9
K982062 510(k) Number: ___
Device Name: CryovCheck™ PNP Platelet Lysate
Indications for Use
Cryo✓Check™ PNP Platelet Lysate is intended for use in the Platelet Neutralization Procedure (PNP) which is useful in detecting the presence of lupus anticoagulants (LA) in human plasma.
Peter E. Mapes
oratory Devices | (GB 2062
Prescription
Use