(268 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, not data processing or algorithmic decision-making. There is no mention of AI, ML, or related concepts.
No
Explanation: The device is intended to collect blood samples and reduce contamination, not to treat a disease or condition.
No
The device is a blood sample collection system designed to reduce contamination in blood cultures by diverting the initial portion of a blood sample. It is used to collect samples, not to analyze them or provide diagnostic information.
No
The device description clearly outlines physical components (tee body assembly, universal culture tube holder, diversion syringe) and the performance studies focus on sterilization, shelf-life, biocompatibility, and bench testing of these physical components. There is no mention of software as a component or its functionality.
Based on the provided text, the LifeOutcomes C-Quest Blood Culture Sampling Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to collect a blood sample and sequester the initial portion to reduce contamination during blood culture collection. It is a device used in the process of obtaining a sample for a diagnostic test (blood culture), but it does not perform the diagnostic test itself.
- Device Description: The description focuses on the physical components and how it diverts and sequesters blood. It doesn't mention any reagents, assays, or analytical processes that are characteristic of IVDs.
- Performance Studies: The performance studies described focus on sterilization, shelf-life, biocompatibility, and bench performance related to the device's function of collecting and diverting blood. There are no studies related to the analytical performance of a diagnostic test (e.g., sensitivity, specificity, etc.).
- Predicate Device: The predicate device (Steripath® Gen2 Blood Collection System) also appears to be a blood collection system designed to reduce contamination, not an IVD.
An IVD is a device intended for use in vitro for the examination of specimens, including blood, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or congenital abnormality, or to determine the safety and compatibility of transfused blood. The C-Quest device facilitates the collection of a sample for such an examination, but it does not perform the examination itself.
N/A
Intended Use / Indications for Use
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.
Product codes
JKA
Device Description
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.
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
medical professionals.
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
Clinical Testing: No clinical data was submitted in this submission.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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).
1
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
2
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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3
| Preparation Date: | 26 January 2024 |
|---|---|
| Submitter: | LifeOutcomes LLC |
| 88 Inverness Circle East, Unit E-102 | |
| Englewood, CO 80112 USA | |
| Submitter | |
| Correspondent | Mr. Robert J. McKinnon |
| Phone: +1 (720) 797-8070 | |
| Email: jon@lifeoutcomes.us | |
| Application | |
| Correspondent: | Thomas Kroenke |
| Principal Consultant | |
| Speed To Market, Inc. | |
| PO Box 3018 | |
| Nederland, CO 80466 USA | |
| tkroenke@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 |
| Regulation | |
| Number: | 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 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.
4
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 Medical
Technologies, Inc.
Steripath Gen2 Blood
Collection System
(Predicate Device -
K192247) | LifeOutcomes LLC
C-Quest Blood Culture
Sampling Device
(Subject Device -
K231282) | Discussion of Differences |
|-------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The Steripath® Gen2 Blood
Collection System is a
system to draw blood for in
vitro diagnostic testing.
The Steripath® Gen2 Blood
Collection System is
indicated for use as a blood
collection system that
diverts and sequesters the
initial specimen prior to
collection of a subsequent
test 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.
Additionally, components of
the system may be used for
infusion following sample
collection after
disconnection of the Initial
Specimen Diversion
Device® (ISDD®).
Venipuncture needles are
indicated for short term
infusion (less than 2 hours). | The LifeOutcomes C-
Quest Blood Culture
Sampling Device (C-
Quest) is 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. | Both C-Quest and the
predicate are indicated
for the collection of blood
samples, and
sequestration of the initial
1.5 ml of blood.
C-Quest components are
not indicated for infusion
whereas the predicate
device components are
indicated for infusion
after removal of the
ISDD. The subject device
is indicated for a subset
of the predicate device's
indication. The difference
does not raise different
questions of safety and
effectiveness. |
| Product Code
and Regulation | JKA, 21 CFR §862.1675.
FPA, 21 CFR §880.5440. | JKA, 21 CFR §862.1675. | C-Quest components are
not indicated for infusion
whereas the predicate
device components are
indicated for infusion
after removal of the
ISDD. The subject device
is indicated for a subset
of the predicate device's
indication. The difference
does not raise different
questions of safety and
effectiveness. |
| Characteristic | Magnolia Medical
Technologies, Inc.
Steripath Gen2 Blood
Collection System
(Predicate Device -
K192247) | LifeOutcomes LLC
C-Quest Blood Culture
Sampling Device
(Subject Device -
K231282) | Discussion of Differences |
| Initial Blood
Volume
Sequestered | 1.5 to 2.0 ml. | A minimum of 1.5 ml, not
to exceed 2.0 ml. | Same; a slight difference
in how the sequestration
amount is stated. |
| Single Use | Yes | Yes | Same. |
| Sterilization
Method and
Sterility
Assurance Level | Ethylene Oxide (EO), SAL
10-6. | EO, SAL 10-6. | Same. |
| Labeled Non-
pyrogenic | Yes. | Yes. | Same. |
| Shelf Life | 1 year. | 18 months. | C-Quest has an 18 month
shelf-life supported by
testing post-accelerated
aging. Therefore, the
difference does not raise
different questions of
safety and effectiveness. |
| Components | The Steripath Gen2 Blood
Collection System includes:
· Initial specimen
diversion device
(ISDD®).
Inlet accessory
(venipuncture needle or
extension set).
· Outlet accessory
(culture blood transfer
adapter or blood
collection syringes). | The C-Quest Blood
Culture Sampling Device
includes:
· C-Quest diversion
device.
Inlet accessory
(venipuncture needle or
extension set).
· Outlet accessory
(blood culture bottle or
blood collection
syringe). | Both the predicate and
subject devices are
systems that incorporate a
blood diversion device,
and inlet and outlet
accessories. Both blood
diversion devices initially
sequester 1.5 to 2.0 ml of
potentially contaminated
blood and prevent
backflow of the
potentially contaminated
blood into the
uncontaminated blood
sample. Both systems
utilize inlet and outlet
accessories, which allow
venous access through
either a venipuncture or
extension line connected
to a patient intravenous
(IV) line. The C-Quest
device was tested to
demonstrate sequestration
performance, backflow
prevention, and syringe
activation force.
Therefore, the differences
do not raise different
questions of safety and
effectiveness. |
| Characteristic | Magnolia Medical
Technologies, Inc.
Steripath Gen2 Blood
Collection System
(Predicate Device -
K192247) | LifeOutcomes LLC
C-Quest Blood Culture
Sampling Device
(Subject Device -
K231282) | Discussion of Differences |
| Materials | Medical grade materials
(stainless steel, PVC tubing,
medical grade adhesives
polycarbonate) | Medical grade materials
(stainless steel, silicone,
polypropylene) | Similar. The subject and
predicate devices are
comprised of medical
grade materials; the
difference in the specific
component materials
were tested to FDA
recognized consensus
standards to demonstrate
biocompatibility
compliance. Therefore,
the difference does not
raise different questions
of safety and
effectiveness. |
| Packaging | Chevron Pouch, 12" x 6"
TPT-0270 to TPF-0524a | Chevron Pouch, 9" x 6" 60
gm/m2 Arjo paper, glue
coated heated sealed to
52µm PET/PE film. | While different materials,
both pouches are
comprised of materials
routinely used for
sterilized and sterilizable
medical device pouches;
the difference in the
specific packaging
materials were tested to
FDA recognized
consensus standards to
demonstrate package
integrity compliance.
Therefore, the difference
does not raise different
questions of safety and
effectiveness. |
| Mechanism of
Action | User-controlled negative
pressure to sequester 1.5 ml
to 2 ml of the initial
contaminated blood drawn
into a chamber.
A second, independent
blood flow path, after the
sequestration of this initial
contaminated blood, is
isolated from this chamber
which prevents the
contaminated blood from
entering the non-
contaminated blood sample. | User-controlled negative
pressure to sequester a
minimum of 1.5 ml of the
initial contaminated blood
drawn. Once the initial
contaminated blood is
drawn into the syringe, it is
isolated in the syringe by
the unidirectional check
value in the C-Quest tee
body assembly which
prevents backflow of the
initial contaminated blood
from entering the non-
contaminated blood
sample.
The subsequent blood flow
is directed into a second,
independent blood flow
path, which could be either
a blood culture bottle or
into a blood collection
syringe activated by the
user pulling the plunger on
the blood collection
syringe. | Same. |
Technology Comparison:
5
Technology Comparison (continued):
6
Technology Comparison (continued):
7
Summary of Verification and Validation Activities:
| Sterilization | The C-Quest sterilization process and sterilized product was validated
in 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 Sterile
Barrier Systems for Medical Devices. |
| | • ISO 10993-7: 2008, Cor1: 2009, Am1: 2019, Biological evaluation
of medical devices – Part 7: Ethylene oxide sterilization residuals. |
| | • ISO 11135: 2014 – Sterilization of health-care products – Ethylene
oxide – Requirements for the development, validation and routine
control of a sterilization process for medical devices. |
| | • Submission and Review of Sterility Information in Premarket
Notification (510(k)) Submissions for Devices Labeled as Sterile, 2
Jan 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.
8
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 in
accordance with the following Standards and guidance document:
ASTM F88-21, Standard Test Method for Seal Strength of Flexible
Barrier Materials. ASTM F1980-16, Standard Guide for Accelerated Aging of Sterile
Barrier Systems for Medical Devices. ISO 10993-7: 2008, Am1: 2019, Biological evaluation of medical
devices – Part 7: Ethylene oxide sterilization residuals (including
Amendment 1: Applicability of allowable limits for neonates and
infants). ISO 11607-1: 2019 – Packaging for terminally sterilized medical
devices - Part 1: Requirements for materials, sterile barrier systems
and packaging systems. ISTA 3A – 18, Packaged-Products for Parcel Delivery System
Shipment 70kg or Less. Submission and Review of Sterility Information in Premarket
Notification (510(k)) Submissions for Devices Labeled as Sterile, 21
Jan 16 Shelf Life of Medical Devices, Apr 91 Test results indicated that the C-Quest sterile packaging complies with
the applicable Standards and guidance document. |
| ------------ | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
9
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 .
Test results indicated that the C-Quest component materials comply with the applicable Standard and guidance document.
10
| Performance Testing
– Bench | C-Quest was tested for performance in accordance with internal
requirements, and the following internal requirements, applicable
Standards, and guidance document: |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Sequestration Verification. Actuation Force Verification. IEC 62366: 2007, Medical devices – Application of usability
engineering 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 risk
management to medical devices. ISO 80369-7:2021 Small-bore connectors for liquids and gases in
healthcare applications-Part 7: Connectors for intravascular or
hypodermic applications. ISO 80639-20: 2015, Small-bore connectors for liquids and gases in
healthcare 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 not
raise new or different questions of safety or effectiveness. The
LifeOutcomes C-Quest™ Blood Culture Sampling Device is
substantially equivalent to the Steripath® Gen2 Blood Collection
System with respect to the indications and technological characteristics. |