(268 days)
The LifeOutcomes C-Quest Blood Culture Sampling Device intended to collect a patient blood sample and sequester the first portion of the sample to reduce the frequency of blood culture contamination when contaminants are present in the initial blood sample compared to blood cultures drawn with standard procedure without manual diversion. It is used in conjunction with either a scalp vein set for venipuncture or access to an existing patient IV using an extension set. C-Quest may be used with a blood culture tube or a standard blood collection syringe.
The LifeOutcomes LLC (LO) C-Quest™ Blood Culture Sampling Device (C-Quest) is a blood collection system that diverts and sequesters the initial specimen prior to collection of a subsequent test sample. This reduces the frequency of blood culture contamination when contaminants are present in the initial blood sample compared to blood cultures drawn with standard procedure without manual diversion. C-Quest is intended for use by medical professionals. The C-Quest consists of three (3) major components: • the tee body assembly. • a universal culture tube holder, and - a third-party, FDA cleared, 5 ml diversion syringe.
The provided text describes the 510(k) premarket notification for the LifeOutcomes C-Quest™ Blood Culture Sampling Device (K231282). This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria and performance data in the typical sense for a diagnostic algorithm.
Here's a breakdown of the requested information based on the provided text. It's important to note that many of these points are not directly addressed as there was no clinical data submitted for this device, and the focus is on device function rather than diagnostic performance.
Acceptance Criteria and Device Performance (Based on Device Characteristics and Bench Testing):
Since no clinical data was submitted, the "acceptance criteria" are derived from the functional requirements and comparisons to the predicate device, as demonstrated through bench testing and compliance with standards.
| Acceptance Criteria (Inferred from testing/comparison) | Reported Device Performance (as stated in the document) |
|---|---|
| Initial Blood Volume Sequestered: Minimum 1.5 ml (Similar to predicate's 1.5-2.0 ml) | A minimum of 1.5 ml, not to exceed 2.0 ml sequestered. |
| Sterilization Assurance Level: SAL 10^-6 (Ethylene Oxide) | EO, SAL 10^-6. |
| Material Biocompatibility: Compliance with ISO 10993-1 and related tests (Cytotoxicity, Sensitization, Intracutaneous reactivity, Acute systemic toxicity, Material-mediated pyrogenicity, Hemolysis, Particulate testing per USP <788>). | Test results indicated that the C-Quest component materials comply with the applicable Standard and guidance document. |
| Shelf Life: At least 1 year (Predicate's shelf life) | 18 months, supported by testing post-accelerated aging. |
| Single Use: Yes | Yes |
| Labeled Non-pyrogenic: Yes | Yes |
| Packaging Material Compatibility/Integrity: Tested to FDA recognized consensus standards (e.g., ASTM F88-21, ISO 11607-1: 2019) | Test results indicated that the C-Quest sterile packaging complies with the applicable Standards and guidance document. |
| Mechanism of Action: User-controlled negative pressure to sequester initial contaminated blood, prevention of backflow, and subsequent independent blood flow path. | Same (as predicate). Tested to demonstrate sequestration performance, backflow prevention, and syringe activation force. |
| Performance - Sequestration Verification: Meets internal requirements. | C-Quest was tested for performance in accordance with internal requirements. |
| Performance - Actuation Force Verification: Meets internal requirements. | C-Quest was tested for performance in accordance with internal requirements. |
| Usability/Human Factors: Complies with IEC 62366: 2007. | C-Quest was tested for performance in accordance with internal requirements. |
| Risk Management: Complies with ISO 14971: 2019. | C-Quest was tested for performance in accordance with internal requirements. |
Detailed Study Information:
The provided document is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence. It explicitly states: "No clinical data was submitted in this submission." Therefore, information typically associated with a diagnostic performance study (like sample sizes for test/training sets, expert readers, ground truth methods, MRMC studies, or standalone performance) is not applicable to this submission as described.
Here's what can be inferred or explicitly stated:
-
Sample size used for the test set and the data provenance:
- Not Applicable. No clinical test set data was submitted. The "test set" for this device constitutes the number of units or materials subjected to bench testing (e.g., sterilization validation, biocompatibility tests, performance bench tests). The document does not specify the number of units tested for these bench activities, only that they comply with standards.
- Data Provenance: Not applicable for clinical data. For bench testing, it would be laboratory testing conducted by the manufacturer or accredited labs.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. No clinical ground truth was established as no clinical data was submitted.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No clinical test set.
-
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:
- Not Applicable. This is a medical device for blood collection, not an AI-assisted diagnostic tool.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device, not an algorithm. Bench testing demonstrates its standalone functional performance (e.g., sequestration, sterility).
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. For the functional tests, the "ground truth" would be the specified characteristics or performance metrics defined by relevant standards (e.g., SAL of 10^-6 for sterility, specific volume for sequestration, passing biocompatibility tests). Outcomes data regarding reduction in blood culture contamination would be the ultimate clinical ground truth, but this was not provided in this submission.
-
The sample size for the training set:
- Not Applicable. This is not an AI/machine learning device.
-
How the ground truth for the training set was established:
- Not Applicable. This is not an AI/machine learning device.
Conclusion from the document:
The LifeOutcomes C-Quest™ Blood Culture Sampling Device gained 510(k) clearance by demonstrating substantial equivalence to a legally marketed predicate device (Steripath® Gen2 Blood Collection System, K192247) through:
- Similar indications for use (with a subset of the predicate's indications, specifically excluding infusion).
- Similar technological characteristics (e.g., mechanism of action, single use, sterilization method).
- Bench testing and compliance with recognized standards for critical device attributes such as:
- Sterilization efficacy (SAL 10^-6, EO).
- Shelf-life (18 months).
- Biocompatibility of materials.
- Performance (sequestration verification, actuation force, backflow prevention).
- Packaging integrity.
The FDA's determination is based on the argument that "The differences between the predicate and the subject device do not raise new or different questions of safety or effectiveness."
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January 26, 2024
LifeOutcomes LLC % Thomas Kroenke Principal Consultant Speed To Market, Inc. P.O. Box 3018 Nederland, Colorado 80466
Re: K231282
Trade/Device Name: LifeOutcomes C-Quest™ Blood Culture Sampling Device Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: Class II Product Code: JKA Dated: December 22, 2023 Received: December 26, 2023
Dear Thomas Kroenke:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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,
ely, Porsche Bennett
Porsche Bennett For David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices. and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K231282
Device Name
LifeOutcomes C-Quest™ Blood Culture Sampling Device
Indications for Use (Describe)
The LifeOutcomes C-Quest Blood Culture Sampling Device intended to collect a patient blood sample and sequester the first portion of the sample to reduce the frequency of blood culture contamination when contaminants are present in the initial blood sample compared to blood cultures drawn with standard procedure without manual diversion. It is used in conjunction with either a scalp vein set for venipuncture or access to an existing patient IV using an extension set. C-Quest may be used with a blood culture tube or a standard blood collection syringe.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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| Preparation Date: | 26 January 2024 |
|---|---|
| Submitter: | LifeOutcomes LLC88 Inverness Circle East, Unit E-102Englewood, CO 80112 USA |
| SubmitterCorrespondent | Mr. Robert J. McKinnonPhone: +1 (720) 797-8070Email: jon@lifeoutcomes.us |
| ApplicationCorrespondent: | Thomas KroenkePrincipal ConsultantSpeed To Market, Inc.PO Box 3018Nederland, CO 80466 USAtkroenke@speedtomarket.net+1 (303) 956 4232 |
| Trade Name: | LifeOutcomes C-Quest™ Blood Culture Sampling Device |
| Common Name: | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Regulation Name: | Blood Specimen Collection Device |
| RegulationNumber: | 21 CFR §862.1675 |
| Product Code: | JKA |
| Predicate Device: | Steripath® Gen2 Blood Collection System (K192247) |
| Device Description: | The LifeOutcomes LLC (LO) C-Quest™ Blood Culture SamplingDevice (C-Quest) is a blood collection system that diverts and sequestersthe initial specimen prior to collection of a subsequent test sample. Thisreduces the frequency of blood culture contamination when contaminantsare present in the initial blood sample compared to blood cultures drawnwith standard procedure without manual diversion. C-Quest is intendedfor use by medical professionals.The C-Quest consists of three (3) major components:• the tee body assembly.• a universal culture tube holder, and |
- a third-party, FDA cleared, 5 ml diversion syringe.
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The LifeOutcomes C-Quest Blood Culture Sampling Device (C-Quest) is Indications for Use: a device intended to collect a patient blood sample and sequester the first portion of the sample to reduce the frequency of blood culture contamination when contaminants are present in the initial blood sample compared to blood cultures drawn with standard procedure without manual diversion. It is used in conjunction with either a scalp vein set for venipuncture or access to an existing patient IV using an extension set. C-Quest may be used with a blood culture tube or a standard blood collection syringe.
The C-Ouest employs the same or similar technological characteristics as the predicate device.
| Characteristic | Magnolia MedicalTechnologies, Inc.Steripath Gen2 BloodCollection System(Predicate Device -K192247) | LifeOutcomes LLCC-Quest Blood CultureSampling Device(Subject Device -K231282) | Discussion of Differences |
|---|---|---|---|
| Indications forUse | The Steripath® Gen2 BloodCollection System is asystem to draw blood for invitro diagnostic testing.The Steripath® Gen2 BloodCollection System isindicated for use as a bloodcollection system thatdiverts and sequesters theinitial specimen prior tocollection of a subsequenttest sample to reduce thefrequency of blood culturecontamination whencontaminants are present inthe initial blood samplecompared to blood culturesdrawn with standardprocedure without manualdiversion.Additionally, components ofthe system may be used forinfusion following samplecollection afterdisconnection of the InitialSpecimen DiversionDevice® (ISDD®).Venipuncture needles areindicated for short terminfusion (less than 2 hours). | The LifeOutcomes C-Quest Blood CultureSampling Device (C-Quest) is a device intendedto collect a patient bloodsample and sequester thefirst portion of the sampleto reduce the frequency ofblood culturecontamination whencontaminants are present inthe initial blood samplecompared to blood culturesdrawn with standardprocedure without manualdiversion. It is used inconjunction with either ascalp vein set forvenipuncture or access toan existing patient IVusing an extension set. C-Quest may be used with ablood culture tube or astandard blood collectionsyringe. | Both C-Quest and thepredicate are indicatedfor the collection of bloodsamples, andsequestration of the initial1.5 ml of blood.C-Quest components arenot indicated for infusionwhereas the predicatedevice components areindicated for infusionafter removal of theISDD. The subject deviceis indicated for a subsetof the predicate device'sindication. The differencedoes not raise differentquestions of safety andeffectiveness. |
| Product Codeand Regulation | JKA, 21 CFR §862.1675.FPA, 21 CFR §880.5440. | JKA, 21 CFR §862.1675. | C-Quest components arenot indicated for infusionwhereas the predicatedevice components areindicated for infusionafter removal of theISDD. The subject deviceis indicated for a subsetof the predicate device'sindication. The differencedoes not raise differentquestions of safety andeffectiveness. |
| Characteristic | Magnolia MedicalTechnologies, Inc.Steripath Gen2 BloodCollection System(Predicate Device -K192247) | LifeOutcomes LLCC-Quest Blood CultureSampling Device(Subject Device -K231282) | Discussion of Differences |
| Initial BloodVolumeSequestered | 1.5 to 2.0 ml. | A minimum of 1.5 ml, notto exceed 2.0 ml. | Same; a slight differencein how the sequestrationamount is stated. |
| Single Use | Yes | Yes | Same. |
| SterilizationMethod andSterilityAssurance Level | Ethylene Oxide (EO), SAL10-6. | EO, SAL 10-6. | Same. |
| Labeled Non-pyrogenic | Yes. | Yes. | Same. |
| Shelf Life | 1 year. | 18 months. | C-Quest has an 18 monthshelf-life supported bytesting post-acceleratedaging. Therefore, thedifference does not raisedifferent questions ofsafety and effectiveness. |
| Components | The Steripath Gen2 BloodCollection System includes:· Initial specimendiversion device(ISDD®).Inlet accessory(venipuncture needle orextension set).· Outlet accessory(culture blood transferadapter or bloodcollection syringes). | The C-Quest BloodCulture Sampling Deviceincludes:· C-Quest diversiondevice.Inlet accessory(venipuncture needle orextension set).· Outlet accessory(blood culture bottle orblood collectionsyringe). | Both the predicate andsubject devices aresystems that incorporate ablood diversion device,and inlet and outletaccessories. Both blooddiversion devices initiallysequester 1.5 to 2.0 ml ofpotentially contaminatedblood and preventbackflow of thepotentially contaminatedblood into theuncontaminated bloodsample. Both systemsutilize inlet and outletaccessories, which allowvenous access througheither a venipuncture orextension line connectedto a patient intravenous(IV) line. The C-Questdevice was tested todemonstrate sequestrationperformance, backflowprevention, and syringeactivation force.Therefore, the differencesdo not raise differentquestions of safety andeffectiveness. |
| Characteristic | Magnolia MedicalTechnologies, Inc.Steripath Gen2 BloodCollection System(Predicate Device -K192247) | LifeOutcomes LLCC-Quest Blood CultureSampling Device(Subject Device -K231282) | Discussion of Differences |
| Materials | Medical grade materials(stainless steel, PVC tubing,medical grade adhesivespolycarbonate) | Medical grade materials(stainless steel, silicone,polypropylene) | Similar. The subject andpredicate devices arecomprised of medicalgrade materials; thedifference in the specificcomponent materialswere tested to FDArecognized consensusstandards to demonstratebiocompatibilitycompliance. Therefore,the difference does notraise different questionsof safety andeffectiveness. |
| Packaging | Chevron Pouch, 12" x 6"TPT-0270 to TPF-0524a | Chevron Pouch, 9" x 6" 60gm/m2 Arjo paper, gluecoated heated sealed to52µm PET/PE film. | While different materials,both pouches arecomprised of materialsroutinely used forsterilized and sterilizablemedical device pouches;the difference in thespecific packagingmaterials were tested toFDA recognizedconsensus standards todemonstrate packageintegrity compliance.Therefore, the differencedoes not raise differentquestions of safety andeffectiveness. |
| Mechanism ofAction | User-controlled negativepressure to sequester 1.5 mlto 2 ml of the initialcontaminated blood drawninto a chamber.A second, independentblood flow path, after thesequestration of this initialcontaminated blood, isisolated from this chamberwhich prevents thecontaminated blood fromentering the non-contaminated blood sample. | User-controlled negativepressure to sequester aminimum of 1.5 ml of theinitial contaminated blooddrawn. Once the initialcontaminated blood isdrawn into the syringe, it isisolated in the syringe bythe unidirectional checkvalue in the C-Quest teebody assembly whichprevents backflow of theinitial contaminated bloodfrom entering the non-contaminated bloodsample.The subsequent blood flowis directed into a second,independent blood flowpath, which could be eithera blood culture bottle orinto a blood collectionsyringe activated by theuser pulling the plunger onthe blood collectionsyringe. | Same. |
Technology Comparison:
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Technology Comparison (continued):
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Technology Comparison (continued):
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Summary of Verification and Validation Activities:
| Sterilization | The C-Quest sterilization process and sterilized product was validatedin accordance with the following Standards and guidance document: |
|---|---|
| • ANSI AAMI ST72: 2019, Bacterial endotoxins - Test methods,routine monitoring, and alternatives to batch testing. | |
| • ASTM F1980-16, Standard Guide for Accelerated Aging of SterileBarrier Systems for Medical Devices. | |
| • ISO 10993-7: 2008, Cor1: 2009, Am1: 2019, Biological evaluationof medical devices – Part 7: Ethylene oxide sterilization residuals. | |
| • ISO 11135: 2014 – Sterilization of health-care products – Ethyleneoxide – Requirements for the development, validation and routinecontrol of a sterilization process for medical devices. | |
| • Submission and Review of Sterility Information in PremarketNotification (510(k)) Submissions for Devices Labeled as Sterile, 2Jan 16 |
An analysis and use of adoption methods indicated that the C-Quest sterilization process and sterilized product complies with the applicable Standards and guidance document.
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Summary of Verification and Validation Activities (continued):
| Shelf-Life | The C-Quest sterile packaging has a shelf life of 18 months.The C-Quest sterile packaging was tested for packaging integrity inaccordance with the following Standards and guidance document:ASTM F88-21, Standard Test Method for Seal Strength of FlexibleBarrier Materials. ASTM F1980-16, Standard Guide for Accelerated Aging of SterileBarrier Systems for Medical Devices. ISO 10993-7: 2008, Am1: 2019, Biological evaluation of medicaldevices – Part 7: Ethylene oxide sterilization residuals (includingAmendment 1: Applicability of allowable limits for neonates andinfants). ISO 11607-1: 2019 – Packaging for terminally sterilized medicaldevices - Part 1: Requirements for materials, sterile barrier systemsand packaging systems. ISTA 3A – 18, Packaged-Products for Parcel Delivery SystemShipment 70kg or Less. Submission and Review of Sterility Information in PremarketNotification (510(k)) Submissions for Devices Labeled as Sterile, 21Jan 16 Shelf Life of Medical Devices, Apr 91 Test results indicated that the C-Quest sterile packaging complies withthe applicable Standards and guidance document. |
|---|---|
| ------------ | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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Summary of Verification and Validation Activities (continued):
Biocompatibility C-Quest is considered a blood path indirect contact, external communicating device for limited contact (less than 24 hours).
The indirect patient-contact materials in C-Quest were tested for biocompatibility compliance in accordance with the following Standard and guidance document:
- . ISO 10993-1: 2018, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process.
- Use of International Standard ISO 10993-1, "Biological evaluation . of medical devices - Part 1: Evaluation and testing within a risk management process," 04 Sep 20.
The following biocompatibility tests were performed:
- Cytotoxicity.
- Sensitization.
- Intracutaneous reactivity.
- Acute system toxicity. ●
- Material-mediated pyrogenicity. ●
- Hemolysis.
- . Particulate testing per USP <788>.
Test results indicated that the C-Quest component materials comply with the applicable Standard and guidance document.
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| Performance Testing– Bench | C-Quest was tested for performance in accordance with internalrequirements, and the following internal requirements, applicableStandards, and guidance document: |
|---|---|
| Sequestration Verification. Actuation Force Verification. IEC 62366: 2007, Medical devices – Application of usabilityengineering to medical devices. ISO 8536-12: 2021, Infusion equipment for medical use – Part 12:Check valves for single use. ISO 14971: 2019, Medical devices – Application of riskmanagement to medical devices. ISO 80369-7:2021 Small-bore connectors for liquids and gases inhealthcare applications-Part 7: Connectors for intravascular orhypodermic applications. ISO 80639-20: 2015, Small-bore connectors for liquids and gases inhealthcare applications – Part 20: Common test methods. | |
| Test results indicated that C-Quest complies with internal requirements,applicable Standards, and the guidance document. | |
| Clinical Testing | No clinical data was submitted in this submission. |
| Conclusion | The differences between the predicate and the subject device do notraise new or different questions of safety or effectiveness. TheLifeOutcomes C-Quest™ Blood Culture Sampling Device issubstantially equivalent to the Steripath® Gen2 Blood CollectionSystem with respect to the indications and technological characteristics. |
§ 862.1675 Blood specimen collection device.
(a)
Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.(b)
Classification. Class II.