Who is the manufacturer of Cryocheck Hex LA?

Precision Biologic filed the 510(k) submission for Cryocheck Hex LA (K193556).

What is the FDA product code for Cryocheck Hex LA?

GFO. It is classified under 21 CFR 864.7925 as a Class 2 device in the Hematology panel.

What is the regulatory pathway for Cryocheck Hex LA?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Cryocheck Hex LA?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Cryocheck Hex LA

K193556 · Precision Biologic · GFO · Oct 23, 2020 · Hematology

Device Facts

Record ID	K193556
Device Name	Cryocheck Hex LA
Applicant	Precision Biologic
Product Code	GFO · Hematology
Decision Date	Oct 23, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 864.7925
Device Class	Class 2

Intended Use

Cryocheck Hex LA is for clinical laboratory use as a qualitative test kit intended to aid in the detection of lupus anticoagulants (LA) in 3.2% citrated human plasma by the application of hexagonal phase phospholipids. Cryocheck Hex LA should be used as an integrated test for lupus anticoagulant detection. For in vitro diagnostic use. The performance of this device has not been established in neonate and pediatric patient populations.

Device Story

CRYOcheck Hex LA is an in vitro diagnostic test kit for clinical laboratory use; detects lupus anticoagulants (LA) in 3.2% citrated human plasma. Device uses hexagonal-phase phospholipid neutralization (HPNT) principle; integrates screening, confirmatory, and mixing procedures. Input: patient plasma samples. Process: plasma incubated with LA Start (pooled normal plasma + heparin neutralizer) and LA Correct (pooled normal plasma + heparin neutralizer + hexagonal phase phospholipid) reagents; APTT reagent and CaCl2 added to trigger intrinsic pathway clotting. Output: clot time difference (delta correction) between reaction mixtures. Performed on Diagnostica Stago STA-R Evolution instrument. Results compared to established cutoff (≥ 6.0 seconds = LA positive). Healthcare providers use output to aid in LA detection; supports clinical diagnosis of antiphospholipid syndrome or related coagulopathies.

Clinical Evidence

No clinical studies performed. Evidence based on analytical performance and method comparison. Method comparison study (n=446 clinical samples) against predicate STACLOT-LA showed 95.6% PPA (91-98% CI), 95.2% NPA (92-97% CI), and 95.3% overall agreement (93-97% CI). Precision studies (single-site and multi-site) evaluated within-run and total imprecision across various LA levels. Interference testing confirmed no clinically significant interference from common endogenous/exogenous substances (e.g., heparin, bilirubin, hemoglobin).

Technological Characteristics

Qualitative HPNT assay. Components: LA Start (pooled normal plasma, buffer, heparin neutralizer), LA Correct (pooled normal plasma, buffer, heparin neutralizer, inverted hexagonal phase phospholipid), LA APTT (silica-based reagent). Form factor: frozen reagents. Energy source: instrument-based (STA-R Evolution). Connectivity: standalone instrument-based processing. Software: embedded instrument firmware. Standards: CLSI EP07, EP05-A3, EP25-A, EP28-A3c.

Indications for Use

Indicated for the qualitative detection of lupus anticoagulants (LA) in 3.2% citrated human plasma. Performance not established in neonate or pediatric populations.

Regulatory Classification

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.

Predicate Devices

Staclot LA (K923731)

Related Devices

K990580 — CRYOCHECK LA SURE, MODEL SUR25-10 · Precision Biologic · Jul 28, 1999
K052124 — ACTICLOT, MODEL 824 · American Diagnostica, Inc. · Oct 17, 2005
K990579 — CRYOCHECK LA CHECK, MODELS CHK25-10 (25 X1.0 ML), CHK80-10 (80 X 1.0 ML) · Precision Biologic · Jul 23, 1999

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it. October 23, 2020 Precision BioLogic Karen Black VP of Compliance and Product Development 140 Eileen Stubbs Avenue Dartmouth, Nova Scotia B3B 0A9 Canada Re: K193556 Trade/Device Name: Cryocheck Hex LA Regulation Number: 21 CFR 864.7925 Regulation Name: Partial Thromboplastin Time Tests Regulatory Class: Class II Product Code: GFO Dated: December 20, 2019 Received: December 23, 2019 Dear Karen Black: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 Part {1}------------------------------------------------ 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Takeesha Taylor-Bell Chief Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K193556 Device Name Cryocheck Hex LA #### Indications for Use (Describe) Cryocheck Hex LA is for clinical laboratory use as a qualitative test kit intended to aid in the detection of lupus anticoagulants (LA) in 3.2% citrated human plasma by the application of hexagonal phase phospholipids. Cryocheck Hex LA should be used as an integrated test for lupus anticoagulant detection. For in vitro diagnostic use. The performance of this device has not been established in neonate and pediatric patient populations. Type of Use (Select one or both, as applicable) | <div> ☒ Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | |--------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------| |--------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------| #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # � 510(k) Summary ## 510(k) Summary cryocheck™ Hex LA™ This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. The assigned 510(k) number is K193556 | Submitter's Information | Precision BioLogic Inc. 140 Eileen Stubbs Ave. Dartmouth, Nova Scotia B3B 0A9 Canada | | | Similarities | | | |--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|-----------------------------------------------------------|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person | Karen M. Black, VP of Compliance & Product Development Phone: 902-468-6422 ext. 226, or 902-706-3125 E-mail: kblack@precisionbiologic.com | | | | Staclot LA | CRYOcheck Hex LA | | Preparation Date | 14 October 2020 | | | Measurand | lupus anticoagulant | lupus anticoagulant | | Device Trade Name | CRYOcheck ™ Hex LA | | | Product Code | GFO | GFO | | Regulatory Information | Regulation Number and Description | | 21 CFR 864.7925 Partial thromboplastin time test | | Partial thromboplastin time tests | Partial thromboplastin time tests | | | Classification | | Class II | Regulation Section | 21 CFR 864.7925 | 21 CFR 864.7925 | | | Product Code | | GFO; Partial thromboplastin time test; 21 CFR 864.7290 | | Partial thromboplastin time tests | Partial thromboplastin time test | | | Classification Panel | | Hematology | Classification | Class II | Class II | | | | | | Panel | 81 (Haematology) | 81 (Haematology) | | Predicate Device | Staclot LA (K923731) | | | Intended Use | The Staclot LA test kit is a reagent system designed for the qualitative detection of lupus anticoagulants (LA) in plasma by the use of hexagonal HII phase phospholipid molecules. (In the USA this procedure has been assigned to the high complexity category per CLIA 1988 - CDC Analyte Code 3728; CDC Test System Code 13285). | CRYOcheck Hex LA is for clinical laboratory use as a qualitative test kit intended to aid in the detection of lupus anticoagulants (LA) in 3.2% citrated human plasma by the application of hexagonal phase phospholipids. CRYOcheck Hex LA should be used as an integrated test for lupus anticoagulant detection. For in vitro diagnostic use. The performance of this device has not been established in neonate and pediatric patient populations. | | Indication for Use/ Intended Use | CRYOcheck Hex LA is for clinical laboratory use as a qualitative test kit intended to aid in the detection of lupus anticoagulants (LA) in 3.2% citrated human plasma by the application of hexagonal phase phospholipids. CRYOcheck Hex LA should be used as an integrated test for lupus anticoagulant detection. For in vitro diagnostic use. The performance of this device has not been established in neonate and pediatric patient populations. | | | Assay Type | Qualitative; hexagonal phase neutralization test | Qualitative; hexagonal phase neutralization test | | Device Description | CRYOcheck Hex LA is comprised of three reagents supplied in a frozen format as follows: LA Start: Pooled normal plasma with buffer and a heparin neutralizer. LA Correct: Pooled normal plasma with buffer, a heparin neutralizer, and inverted hexagonal phase phospholipid. LA APTT: Silica-based lupus sensitive APTT reagent with stabilizer. | | | Methodology | The Staclot LA test procedure is based on the following principle: the test plasma that is suspected to contain LA is first allowed to incubate at 37°C with (Tube 2) and without (Tube 1) hexagonal phase phosphatidylethanolamine (HPE) (Reagent 2); next, an APTT is performed on both tubes using an LA sensitive reagent (Reagent 4); if LA were present in the test plasma, they would be neutralized by HPE in tube 2, and this would result in a shortening of the clotting time of tube 2 compared with that of tube 1. By comparing the difference between the two clotting times, the presence of LA antibodies in the test plasma can be identified. The Reagent 3 contains a heparin inhibitor which makes the test system insensitive to heparin levels up to 1 IU/mL. Furthermore, the Staclot LA procedure calls for the addition of a normal plasma (Reagent 3) to the test system to | CRYOcheck Hex LA is a hexagonal-phase phospholipid neutralization test (HPNT), which is an integrated test that combines screening, confirmatory and mixing test procedures into a single assay. CRYOcheck LA works on the principle that LA are neutralized by hexagonal phase phospholipids that are present in the assay's confirmatory reaction mixture and not the screening reaction mixture. The presence of LA in plasma samples is confirmed by the correction of APTT clot times in the presence of a reaction mixture containing hexagonal phase phospholipids. In the CRYOcheck Hex LA assay, the test plasma suspected to contain LA is incubated in two reaction cuvettes, both of which entail dilution with pooled normal | | | Comparison to Predicate | | | | | | | Item | Predicate | | New Device | | | | | Proprietary and Established Names | Staclot LA | | CRYOcheck Hex LA | | | | | Manufacturer | American Bioproducts Inc (original applicant); Diagnostica Stago (current manufacturer) | | Precision BioLogic Inc | | | | {4}------------------------------------------------ {5}------------------------------------------------ | Similarities | | | |-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Staclot LA | CRYOcheck Hex LA | | | clotting time due to factor deficiencies that might be present. If the Staclot LA does not produce a shortening of the clotting time, then the presence of anti-factor antibodies should be suspected; in this case, use an appropriate test for anti-factor antibodies. Compare the clotting time of tube 1 (CT1) with that of tube 2 (CT2). A shortening of clotting time of 8 seconds or more of tube 2 compared with that of tube 1 is significant of a neutralization of anti-phospholipid antibodies (this 8- second cut-off in clotting times has been determined with the ST4/ST art® instrument - Diagnostica Stago). | neutralizer), thus satisfying the mixing test requirement. In the first cuvette, the screening test reaction is performed by mixing the test plasma with the LA Start reagent (pooled normal plasma). In the second cuvette, the confirmatory reaction is performed by mixing the test plasma with the LA Correct reagent (pooled normal plasma with hexagonal phase phospholipid). The LA APTT reagent is then added to each cuvette, followed by 0.025 M CaCl2 to activate clotting via the intrinsic pathway. Clot times are recorded for the screening reaction mixture containing LA Start and the confirmatory reaction mixture containing LA Correct. The result is reported as the difference in clot time in seconds ("delta correction") between LA Start and LA Correct cuvettes. delta correction = (CT LA Start) - (CT LA Correct) The result is then compared to an established cut-off. A result greater than or equal to the established cut-off is considered LA positive, while a result less than the established cut-off is considered LA negative. | | Expression of results | Qualitative; results are reported as clot time delta (seconds) and are interpreted as positive or negative relative to an established cut-off value. | Qualitative; results are reported as clot time delta (seconds) and are interpreted as positive or negative relative to an established cut-off value. | {6}------------------------------------------------ | Differences | | | | | | | | | |---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--| | | Staclot LA | CRYOcheck Hex LA | | | | | | | | Format | Staclot LA is comprised of three lyophilized reagents and two reconstitution liquids as follows: Reagent 1 : ready-for-use buffer Reagent 2 : lyophilized hexagonal phase phosphatidylethanolamine Reagent 3 : lyophilized normal human plasma containing a heparin inhibitor Reagent 4 : lyophilized PTT-LS reagent consisting of cephalin prepared from rabbit cerebral tissues and a particulate siliceous activator Reagent 5 : solvent for reconstitution of Reagent 4. | CRYOCheck Hex LA is comprised of three reagents supplied in a frozen format as follows: LA Start : Pooled normal plasma with buffer and a heparin neutralizer. LA Correct : Pooled normal plasma with buffer, a heparin neutralizer, and inverted hexagonal phase phospholipid. LA APTT : Silica-based LA sensitive APTT reagent with stabilizer. | | | | | | | | Storage | 2-8°C until expiration | ≤-70°C until expiration | | | | | | | | Instrument | Manual (ST4/ST art®) | STA-R Evolution® | | | | | | | | Associated Controls | STA® - Control LA 1 + 2 | CRYOCheck Lupus Negative Control CRYOCheck Weak Lupus Positive Control CRYOCheck Lupus Positive Control | | | | | | | | Cut-off | A shortening of clotting time of 8 seconds or more of tube 2 compared with that of tube 1 is significant of a neutralization of anti-phospholipid antibodies (this 8-second cut-off in clotting times has been determined with the ST4/ST art® instrument - Diagnostica Stago). Each laboratory should verify this 8-second cut-off by testing the plasma of at least 20 normal individuals, using its own methodology to obtain the mean delta T + 4 SD. | The cut-off for the assay delta correction was determined using pooled data from a normal range study conducted on Stago STA-R Evolution® analyzers and calculating the mean + 4 SD, with the following results: Delta Correction Interpretation < 6.0 seconds LA Negative ≥ 6.0 seconds LA Positive The results were obtained using specific lots of reagent. The cut-off is calculated as the mean of the delta correction + 4 SD, consistent with accepted methods for hexagonal phase neutralization tests. This method of establishing cut-off is different than that indicated for confirmatory tests in Pengo et al., 2009.1 Each laboratory should verify its own cut-off, by | | | | | | | 1 Pengo V, Tripodi A, Reber G, Rand JH, Ortel TL, Galli M, deGroot PG. Update of the guidelines for lupus anticoagulant detection. J. Thromb. Haemost. 2009;7(10):1737-1740. {7}------------------------------------------------ | Differences | | | |-----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Staclot LA | CRYOcheck Hex LA | | | | testing the plasma of at least 20 normal individuals. | | Heparin Interference | No interference up to 1 IU/mL | Unfractionated heparin: no interference up to 2 IU/mL Low molecular weight heparin: no interference up to 2 IU/mL | | Direct Thrombin and Xa Inhibitor Interference | Thrombin inhibitors (e.g., hirudin, argatroban...) present in the sample to be tested may interfere in the test and lead to falsely positive results. | Dabigatran, rivaroxaban, and fondaparinux do not interfere with the interpretation of CRYOcheck Hex LA results but may increase the delta correction of LA positive samples. | | Warfarin Interference | The Staclot® LA procedure was used to test plasmas from stabilized coumadin patients (n = 29). All plasmas gave negative results with Staclot® LA. | Plasma samples with elevated INR (up to 4.5) do not interfere with the interpretation of CRYOcheck Hex LA results | | Factor VIII Inhibitor Antibody Interference | The presence of anti-factor antibodies does not normally produce a correction in clotting time with the Staclot LA test procedure. However considering the heterogeneity of these antibodies, some may interfere in the test. Consequently, when these are suspected, use an appropriate test for anti-factor antibodies | Factor VIII inhibitor antibodies do not interfere with the interpretation of CRYOcheck Hex LA results, but at titers above 15 BU/mL may increase the delta correction of LA positive samples. | | Factor Deficiency Interference | A total of 21 factor deficient plasmas, comprising deficiencies of F. VIII (n = 8), F. VIII with the presence of anti-F. VIII-antibodies (n = 5), F. IX (n = 4), F. XI (n = 2), F. XII (n = 1) and F. II (n = 1), were tested with the Staclot® LA procedure. The observed CT1-CT2 was found in all cases < 8 seconds. | Factor VII and factor IX deficiencies do not interfere with CRYOcheck Hex LA. Abnormally low factor X activities (below 50%) do not interfere with the interpretation of CRYOcheck Hex LA results but may increase the delta correction for LA positive samples. Abnormally low factor II activities (below 50%) may interfere with the interpretation of CRYOcheck Hex LA, potentially resulting in false negative results for weakly LA positive plasmas. | | HIL interference | Unknown | Hemoglobin: ≤ 500 mg/dL Bilirubin (unconjugated): ≤ 20 mg/dL Bilirubin (conjugated): ≤ 2 mg/dL Intralipid: ≤ 500 mg/dL | | Differences | | | | | Staclot LA | CRYOcheck Hex LA | | C-reactive protein interference | Unknown | C-reactive protein does not interfere with the interpretation of CRYOcheck Hex LA results but at concentrations above 15 µg/mL may increase the delta correction of LA positive samples. | | Elevated factor interference | Unknown | Elevated factor VIII activity (up to 180%) does not interfere with CRYOcheck Hex LA. Elevated fibrinogen concentrations do not interfere with the interpretation of CRYOcheck Hex LA results but may increase the delta correction of LA positive samples. | {8}------------------------------------------------ {9}------------------------------------------------ #### Performance Summary: All studies were performed using CRYOcheck Hex LA on Diagnostica Stago STA-R Evolution® instrument(s). #### Precision An internal precision study was performed using three different lots of CRYOcheck Hex LA on a STA-R Evolution instrument in accordance with CLSI EP05-A3. Three lot numbers of CRYOcheck Hex LA were used to test three control plasmas and five plasmas with varying LA positivity, in duplicate, twice a day for 20 days. The results demonstrated a pooled precision of < 5% CV for LA Start and <…

Cryocheck Hex LA

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

Cryocheck Hex LA

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

Create Alert

Search Filters

Agent Token

Welcome

Check your email

Welcome!