(29 days)
Not Found
No
The description focuses on real-time PCR technology and does not mention any AI or ML components.
No
This device is an in vitro diagnostic (IVD) test used to detect and differentiate HSV-1 and HSV-2 DNA, aiding in the diagnosis of infections. It does not provide therapy or treatment.
Yes
This device is intended as an aid in the diagnosis of HSV-1 and HSV-2 infections of the CNS.
No
The device description explicitly states that the system consists of the Simplexa™ HSV 1 & 2 Direct assay, the 3M Integrated Cycler (with 3M Integrated Cycler Studio Software), the Direct Amplification Disc and associated accessories. This includes hardware components (3M Integrated Cycler, Direct Amplification Disc, accessories) in addition to software (3M Integrated Cycler Studio Software).
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative detection and differentiation of HSV-1 and HSV-2 DNA in cerebrospinal fluid (CSF) samples from patients suspected of herpes simplex virus (HSV) infections of the central nervous system (CNS)." This involves testing samples taken from the human body to provide information about a disease state.
- Device Description: The description details a "real-time PCR assay system" that analyzes "unprocessed CSF specimens." This is a laboratory-based test performed on biological samples.
- Professional Use Only: The indication that it's for "professional use only" is consistent with IVDs, which are typically used by trained laboratory personnel.
- Control Pack: The mention of a "Positive Control Pack" further indicates it's a diagnostic test with quality control measures.
All of these characteristics align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Focus Diagnostics Simplexa™ HSV 1 & 2 Direct is intended for use on the 3M Integrated Cycler instrument for the qualitative detection and differentiation of HSV-1 and HSV-2 DNA in cerebrospinal fluid (CSF) samples from patients suspected of herpes simplex virus (HSV) infections of the central nervous system (CNS). This test is intended as an aid in the diagnosis of HSV-1 and HSV-2 infections of the CNS.
Negative results do not preclude HSV-1 or HSV-2 infection and should not be used as the sole basis for treatment or other patient management decisions.
The assay is not intended for use as a donor screening test. The assay is for professional use only.
The Simplexa™ HSV 1 & 2 Positive Control Pack is intended to be used as a control with the Simplexa™ HSV 1 & 2 Direct kit. This control is not intended for use with other assays or systems.
Product codes (comma separated list FDA assigned to the subject device)
PGH
Device Description
The Simplexa™ HSV 1 & 2 Direct assay system is a real-time PCR that enables the direct amplification, detection and differentiation of HSV-1 and/or HSV-2 DNA from unprocessed CSF specimens without nucleic acid extraction. The system consists of the Simplexa™ HSV 1 & 2 Direct assay, the 3M Integrated Cycler (with 3M Integrated Cycler Studio Software), the Direct Amplification Disc and associated accessories.
In the Simplexa™ HSV 1 & 2 Direct assay, bi-functional fluorescent probe-primers are used together with corresponding reverse primers to amplify HSV-1, HSV-2 and internal control targets. Well conserved regions of the HSV-1 and HSV-2 DNA polymerase genes are targeted to identify HSV-1 and HSV-2 DNA respectively in the specimen. An internal control is used to detect PCR failure and/or inhibition.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Central nervous system (CNS)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional use only.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
§ 866.3307 Herpes simplex virus nucleic acid-based assay for central nervous system infections.
(a)
Identification. A herpes simplex virus nucleic acid-based assay for central nervous system infections is a qualitative in vitro diagnostic device intended for the detection and differentiation of HSV-1 and HSV-2 in cerebrospinal fluid (CSF) samples from patients suspected of Herpes Simplex Virus (HSV) infections of the central nervous system (CNS). This test is intended as an aid in the diagnosis of HSV-1 and HSV-2 infections of the CNS. Negative results do not preclude HSV-1 or HSV-2 infection and should not be used as the sole basis for treatment or other patient management decisions.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Design verification and validation must include:
(i) Detailed documentation for the device description, including the device components, ancillary reagents required but not provided, and a detailed explanation of the methodology, including primer design and selection.
(ii) Detailed documentation from the following analytical and clinical performance studies: Analytical sensitivity (limit of detection), reactivity, inclusivity, precision, reproducibility, interference, cross reactivity, carryover, and cross contamination. Documentation must include reagent and sample stability recommendations.
(iii) Detailed documentation from a clinical study. The study, performed on a study population consistent with the intended use population, must compare the device performance to the results of two polymerase chain reaction methods followed by bidirectional sequencing.
(iv) Documentation of an appropriate end user device training program that will be offered as part of efforts to mitigate the risk of failure to correctly operate the instrument.
(v) Quality assurance protocols and detailed documentation for device software, including standalone software applications and hardware-based devices that incorporate software.
(2) The labeling required under § 809.10(b) of this chapter must include:
(i) A detailed explanation of the interpretation of results and acceptance criteria.
(ii) A limiting statement indicating that negative results do not preclude HSV-1 or HSV-2 infection and should not be used as the sole basis for treatment or other patient management decisions.
0
Image /page/0/Picture/0 description: The image shows the logo for Focus Diagnostics. The logo consists of the word "FOCUS" in bold, sans-serif font, with the word "Diagnostics" in a smaller font size underneath. A curved, swooping line is placed to the left of the word "FOCUS", adding a dynamic element to the design. The logo is in black and white.
JUL 0 1 2014
510(k) Summary
Simplexa™ HSV 1 & 2 Direct REF MOL2150 Simplexa™ HSV 1 & 2 Positive Control Pack |REF|MOL2160 Prepared Date: July 1, 2014 Page 1 of 4
| Applicant | Focus Diagnostics, Inc.
11331 Valley View Street
Cypress, California 90630
USA |
|--------------------------------|-----------------------------------------------------------------------------------------|
| Establishment Registration No. | 2023365 |
| Contact Person | Sharon Young
tel 562.240.6680
fax 562.240.6529
syoung@focusdx.com |
| Summary Date | July 1, 2014 |
| Proprietary Name | Simplexa™ HSV 1 & 2 Direct and Simplexa™ HSV 1 & 2 Positive
Control Pack |
| Generic Name | HSV-1 & HSV-2 DNA detection |
| Classification | Class II |
| US Product Code | PGH - HSV-1 and HSV-2 CNS Nucleic-Acid based panel |
| Regulation Number | §21 CFR 866.3307 |
| Predicate Device | K133621 |
INTENDED USE
The Focus Diagnostics Simplexa™ HSV 1 & 2 Direct is intended for use on the 3M Integrated Cycler instrument for the qualitative detection and differentiation of HSV-2 DNA in cerebrospinal fluid (CSF) samples from patients suspected of herpes simplex virus (HSV) infections of the central nervous system (CNS). This test is intended as an aid in the diagnosis of HSV-1 and HSV-2 infections of the CNS.
Negative results do not preclude HSV-1 or HSV-2 infection and should not be used as the sole basis for treatment or other patient management decisions.
The assay is not intended for use as a donor screening test. The assay is for professional use only.
INTENDED USE
The Simplexa™ HSV 1 & 2 Positive Control Pack is intended to be used as a control with the Simplexa™ HSV 1 & 2 Direct kit. This control is not intended for use with other assays or systems.
DEVICE DESCRIPTION
The Simplexa™ HSV 1 & 2 Direct assay system is a real-time PCR that enables the direct amplification, detection and differentiation of HSV-1 and/or HSV-2 DNA from unprocessed CSF specimens without nucleic acid extraction. The system consists of the Simplexa™ HSV 1 & 2 Direct assay, the 3M Integrated Cycler (with 3M Integrated Cycler Studio Software), the Direct Amplification Disc and associated accessories.
In the Simplexa™ HSV 1 & 2 Direct assay, bi-functional fluorescent probe-primers are used together with corresponding reverse primers to amplify HSV-1, HSV-2 and internal control targets. Well conserved regions of the HSV-1 and HSV-2 DNA polymerase genes are targeted to identify HSV-1 and HSV-2 DNA respectively in the specimen. An internal control is used to detect PCR failure and/or inhibition.
1
Image /page/1/Picture/0 description: The image shows the logo for Focus Diagnostics. The logo features the word "FOCUS" in bold, uppercase letters, with a curved line extending from the left side of the "F" and arching over the top of the word. Below "FOCUS" is the word "Diagnostics" in a smaller, non-bold font, underlined with a thin line.
K141458
510(k) Summary Simplexa™ HSV 1 & 2 Direct REF MOL2150 Simplexa™ HSV 1 & 2 Positive Control Pack |REF|MOL2160 Prepared Date: July 1, 2014 Page 2 of 4
Simplexa™ HSV 1 & 2 Direct REF MOL2150
| Kit Description | |||||||
|---|---|---|---|---|---|---|---|
| Component Name | REF | EC SYMBOL | |||||
| ON LABEL | Abbreviated Name | Cap Color | Number of Vials | Reactions per Vial/Kit | Volume per Vial | ||
| Simplexa™ HSV 1 & 2 | |||||||
| Direct Reaction Mix | MOL2151 | REAG | . RM | Brown | 24 | 1/24 | 50 $ μ $ L |
Component Description
| Kit Component | Contents | ||||
|---|---|---|---|---|---|
| DNA polymerase, buffer, dNTPs, template DNA (Internal Control) dye-labeled fluorescent probe- | |||||
| primers specific for detection of HSV-1 and/or HSV-2 and for the DNA Internal Control. | |||||
| Target | Probe | ||||
| Fluorophore | |||||
| (Dye) | Excitation (nm) | Emission (nm) | Targeted Gene | ||
| Simplexa™ HSV 1 & | |||||
| 2 Direct Reaction Mix | |||||
| (RM) | HSV-1 | CFR610 | 590 | 610 | HSV-1 DNA |
| polymerase | |||||
| HSV-2 | FAM | 495 | 520 | HSV-2 DNA | |
| polymerase | |||||
| DNA Internal | |||||
| Control | Q670 | 644 | 670 | NA | |
| Simplexa™ HSV 1 & | |||||
| 2 Kit Barcode Card | Assay specific parameters. |
Simplexa™ HSV 1 & 2 Positive Control Pack REF MOL2160
Product Description
| Component Name | REF | Description | Cap Color | Number of Vials | Reactions per Vial/Kit | Volume per Vial |
|---|---|---|---|---|---|---|
| Simplexa™ HSV 1 & 2 Direct Positive Control | MOL2161 | Inactivated HSV-1 Virus, Inactivated HSV-2 Virus | Red | 10 | 1/10 | 100 μL |
MATERIALS SUPPLIED SEPARATLY
Direct Amplification Disc Kit (REF MOL1455) 1.
- a. Direct Amplification Discs for use on the 3M Integrated Cycler.
2
Image /page/2/Picture/0 description: The image shows the logo for Focus Diagnostics. The logo features the word "FOCUS" in bold, uppercase letters. Below "FOCUS" is the word "Diagnostics" in a smaller font size, underlined with a thin line. To the left of the word "FOCUS" is a curved, black shape that resembles a check mark.
K141458
510(K) Simplexa™ HSV 1 & 2 Direct REF|MOL2150
Simplexa™ HSV 1 & 2 Positive Control Pack [RE] MOL2150
Simplexa™ HSV 1 & 2 Positive Control Pack [REF]MOL2160 Prepared Date: July 1, 2014 Page 3 of 4
COMPARISON TO PREDICATE
Similarities
| Feature | Predicate K133621 | Modified Device K141458 |
|---|---|---|
| Intended Use | The Focus Diagnostics Simplexa™ | |
| HSV 1 & 2 Direct is intended for use | ||
| on the 3M Integrated Cycler | ||
| instrument for the qualitative | ||
| detection and differentiation of HSV- | ||
| 1 and HSV-2 DNA in cerebrospinal | ||
| fluid (CSF) samples from patients | ||
| suspected of Herpes Simplex Virus | ||
| (HSV) infections of the central | ||
| nervous system (CNS). This test is | ||
| intended as an aid in the diagnosis of | ||
| HSV-1 and HSV-2 infections of the | ||
| CNS. |
Negative results do not preclude
HSV-1 or HSV-2 infection and should
not be used as the sole basis for
treatment or other patient
management decisions.
The assay is not intended for use as
a donor screening test. The assay is
for professional use only.
The Positive Control is intended to
be used as a control with the
Simplexa™ HSV 1 & 2 Direct. This
control is not intended for use with
other assays or systems. | Same |
| Technology | The Simplexa™ HSV 1 & 2 Direct
assay system is a real-time PCR that
enables the direct amplification,
detection and differentiation of HSV-
1 and/or HSV-2 DNA from
unprocessed CSF specimens without
nucleic acid extraction. | Same |
| Analyte | HSV-1 & HSV-2 DNA. | Same |
| Assay Type | Qualitative. | Same |
3
Image /page/3/Picture/0 description: The image shows the logo for Focus Diagnostics. The logo consists of the word "FOCUS" in large, bold, sans-serif font, with the word "Diagnostics" in a smaller font size underneath. A curved, swooping shape is positioned to the left of the word "FOCUS", adding a dynamic element to the design. The overall design is simple, clean, and professional.
510(k) Summary Simplexa™ HSV 1 & 2 Direct REF MOL2150 Simplexa™ HSV 1 & 2 Positive Control Pack |REF| MOL2160 Prepared Date: July 1, 2014 Page 4 of 4
Differences
| Predicate | Modified Device | |
|---|---|---|
| Integrated Cycler Studio Software | Integrated Cycler Studio Software | |
| version 5.0 or higher. | Integrated Cycler Studio Software | |
| version 6.0 or higher. |
Software changes were made to
restrict manual modification of the
spectral matrix and to resolve
anomalies. |
SUMMARY OF DESIGN CONTROL ACTIVITIES
Design controls in accordance with $21 CFR 820.30 were conducted to modify the device. Verification activities for the Integrated Cycler Studio software version 6.0 included development of verification test plans with defined acceptance criteria (design inputs), conducting and documenting verification testing and review of the verification results as they compared to the verification test plans predetermined acceptance criteria (design outputs). Integrated Cycler Studio software version 6.0 was validated in a similar fashion with the development of validation test plans with defined acceptance criteria (design inputs), conducting validation testing and review of the validation results as they compared to the validation test plans predetermined acceptance criteria (design outputs). The results of verification and validation of Integrated Cycler Studio software version 6.0 show the results met the predetermined acceptance criteria. The results of assays ran with the Integrated Cycler Studio software version 6.0 demonstrate that the results obtained with the previously released versions of Integrated Cycler Studio software were equivalent to the results obtained using Integrated Cycler Studio software version 6.0.
The changes made to the Integrated Cycler Studio software version 6.0 were assessed using risk management. Risk management involved analysis of the characteristics of Integrated Cycler Studio software version 6.0, the characteristics of the process that might create a hazard with the Integrated Cycler Studio software version 6.0, and the possible hazards associated with the use of the Integrated Cycler Studio software version 6.0. The risk management process consisted of risk analysis, risk evaluation, risk benefit and evaluation of residual risk acceptability. A thorough review was performed to ensure identified from all hazardous situations were considered to assess if previously estimated risks were affected. After risk control measures were applied, any residual risk(s) were evaluated. Acceptability of overall residual risk took into consideration whether anticipated medical benefits outweighed the overall residual risks of a product placed on the market for its intended use.
A declaration of conformity to design controls in accordance to §21 CFR 820.30 is included in the K141458 Simplexa™ HSV 1 & 2 Direct REF MOL2150 and Simplexa™ HSV 1 & 2 Positive Control Pack [REF] MOL2160 Special 510(k) submission. The declaration of conformity was signed by the individuals responsible for the activities.
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Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an emblem that appears to be a stylized representation of an eagle or bird.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 1, 2014
FOCUS DIAGNOSTICS SHARON YOUNG 11331 VALLEY VIEW STREET CYPRESS, CA 90630
Re: K141458 Trade/Device Name: Simplexa™ HSV 1 & 2 Direct and Simplexa™ HSV 1 & 2 Positive Control Pack Regulation Number: 21 CFR 866.3307 Regulation Name: Herpes simplex virus nucleic acid-based assay for central nervous system infections Regulatory Class: II Product Code: PGH Dated: May 29, 2014 Received: June 2, 2014
Dear Ms. Young:
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. 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 }] (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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
5
Page 2-Ms. Young
If vou desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/delault.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Stephen J. Lovell -S
Sally A. Hojvat. M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
6
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K141458
Device Name Simplexa™ HSV 1 & 2 Direct Simplexa™ HSV 1 & 2 Positive Control Pack
Indications for Use (Describe)
Simplexa™ HSV 1 & 2 Direct (MOL2150)
The Focus Diagnostics Simplexa™ HSV 1 & 2 Direct is intended for use on the 3M Integrated Cycler instrument for the qualitative detection and differentiation of HSV-1 and HSV-2 DNA in cerebrospinal fluid (CSF) samples from patients suspected of herpes simplex virus (HSV) infections of the central nervous system (CNS). This test is intended as an aid in the diagnosis of HSV-1 and HSV-2 infections of the CNS.
Negative results do not preclude HSV-1 or HSV-2 infection and should not be used as the sole basis for treatment or other patient management decisions.
The assay is not intended for use as a donor screening test. The assay is for professional use only.
SimplexaTM HSV 1 & 2 Positive Control Pack (MOL2160)
The Simplexa™ HSV 1 & 2 Positive Control Pack is intended to be used as a control with the Simplexa™ HSV 1 & 2 Direct kit. This control is not intended for use with other assays or systems.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Stephen J. Lovell -S 2014.07.01 14:37:03 -04'00' Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
7
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