Predicate Devices

K042542, K043133, K050858, K053335, K060046, K060047, K060048, K060298, K060370, K060410, K060411, K060413, K060641, K070086, K070094, K070097, K070267, K070268, K070269, K070381, K070404, K070405, K070406, K070407, K070408, K070409, K080277, K080340, K090332, K090333, K090334, K090335, K090363, K090364, K090365, K090366, K090367, K090368, K090369, K100295, K100344, K100345, K100346, K100347, K100348, K100349, K100350, K100351, K100352, K100353, K100354, K100355, K110665, K110666, K110667, K110668, K110669, K110670, K110671, K110672, K110673, K110674, K110675, K110676, K110677, K110678, K110679, K110680, K120409, K120410, K120411, K120412, K120413, K120414, K120415, K120416, K120417, K120418, K130109, K130386, K130387, K130388, K130389, K130390, K130391, K130392, K130393, K130394, K130395, K130396, K130397, K140026, K140027, K140028, K140029, K140030, K140031, K140032, K140033, K140034, K140035, K140036, K140037, K140320, K140321, K140322, K140323, K140324, K140325, K140326, K140327, K140328, K140329, K140330, K140331, K140332, K140334, K140335, K140336, K140337, K140338, K140339, K140340, K140341, K140342, K140343, K140344, K140345, K140346, K140347, K140348, K140349, K140350, K151624, K151978, K151979, K151980, K160010, K160011, K160012, K160013, K160014, K160015, K160016, K160017, K160018, K160019, K160020, K160021, K160022, K160023, K160024, K160025, K160026, K160027, K160028, K160029, K160030, K170068, K170069, K170070, K170071, K170072, K170153, K170154, K170258, K170259, K170260, K170261, K170262, K170263, K170264, K170265, K170266, K170267, K170268, K170269, K170270, K170271, K170272, K170273, K170274, K170275, K170276, K170277, K170278, K170279, K170280, K170281, K170282, K170283, K170284, K170285, K170286, K170287, K170288, K170289, K170290, K170291, K170292, K170293, K170294, K170295, K170296, K170297, K170298, K170299, K170300, K170301, K170302, K170303, K170304, K170305, K170306, K170307, K170308, K170309, K170310, K170311, K170312, K170313, K170314, K170315, K170316, K170317, K170318, K170319, K170320, K170321, K170322, K170323, K170324, K170325, K170326, K170327, K170328, K170329, K170330, K170331, K170332, K170333, K170334, K170335, K170336, K170337, K170338, K170339, K170340, K170341, K170342, K170343, K170344, K170345, K170346, K170347, K170348, K170349, K170350, K170351, K170352, K170353, K170354, K170355, K170356, K170357, K170358, K170359, K170360, K170361, K170362, K170363, K170364, K170365, K170366, K170367, K170368, K170369, K170370, K170371, K170372, K170373, K170374, K170375, K170376, K170377, K170378, K170379, K170380, K170381, K170382, K170383, K170384, K170385, K170386, K170387, K170388, K170389, K170390, K170391, K170392, K170393, K170394, K170395, K170396, K170397, K170398, K170399, K170400, K170401, K170402, K170403, K170404, K170405, K170406, K170407, K170408, K170409, K170410, K170411, K170412, K170413, K170414, K170415, K170416, K170417, K170418, K170419, K170420, K170421, K170422, K170423, K170424, K170425, K170426, K170427, K170428, K170429, K170430, K170431, K170432, K170433, K170434, K170435, K170436, K170437, K170438, K170439, K170440, K170441, K170442, K170443, K170444, K170445, K170446, K170447, K170448, K170449, K170450, K170451, K170452, K170453, K170454, K170455, K170456, K170457, K170458, K170459, K170460, K170461, K170462, K170463, K170464, K170465, K170466, K170467, K170468, K170469, K170470, K170471, K170472, K170473, K170474, K170475, K170476, K170477, K170478, K170479, K170480, K170481, K170482, K170483, K170484, K170485, K170486, K170487, K170488, K170489, K170490, K170491, K170492, K170493, K170494, K170495, K170496, K170497, K170498, K170499, K170500, K170501, K170502, K170503, K170504, K170505, K170506, K170507, K170508, K170509, K170510, K170511, K170512, K170513, K170514, K170515, K170516, K170517, K170518, K170519, K170520, K170521, K170522, K170523, K170524, K170525, K170526, K170527, K170528, K170529, K170530, K170531, K170532, K170533, K170534, K170535, K170536, K170537, K170538, K170539, K170540, K170541, K170542, K170543, K170544, K170545, K170546, K170547, K170548, K170549, K170550, K170551, K170552, K170553, K170554, K170555, K170556, K170557, K170558, K170559, K170560, K170561, K170562, K170563, K170564, K170565, K170566, K170567, K170568, K170569, K170570, K170571, K170572, K170573, K170574, K170575, K170576, K170577, K170578, K170579, K170580, K170581, K170582, K170583, K170584, K170585, K170586, K170587, K170588, K170589, K170590, K170591, K170592, K170593, K170594, K170595, K170596, K170597, K170598, K170599, K170600, K170601, K170602, K170603, K170604, K170605, K170606, K170607, K170608, K170609, K170610, K170611, K170612, K170613, K170614, K170615, K170616, K170617, K170618, K170619, K170620, K170621, K170622, K170623, K170624, K170625, K170626, K170627, K170628, K170629, K170630, K170631, K170632, K170633, K170634, K170635, K170636, K170637, K170638, K170639, K170640, K170641, K170642, K170643, K170644, K170645, K170646, K170647, K170648, K170649, K170650, K170651, K170652, K170653, K170654, K170655, K170656, K170657, K170658, K170659, K170660, K170661, K170662, K170663, K170664, K170665, K170666, K170667, K170668, K170669, K170670, K170671, K170672, K170673, K170674, K170675, K170676, K170677, K170678, K170679, K170680, K170681, K170682, K170683, K170684, K170685, K170686, K170687, K170688, K170689, K170690, K170691, K170692, K170693

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description details a chromogenic culture medium that relies on enzymatic reactions and visual color differentiation of bacterial colonies, not computational analysis or learning algorithms. The performance studies compare the medium's results to traditional culture methods and biochemical tests, with no mention of AI/ML components.

Therapeutic

No
The device is a diagnostic tool used for detecting VRE colonization and is explicitly stated as "not intended to diagnose VRE infection or to guide or monitor treatment for infections," which excludes it from being a therapeutic device.

Diagnostic

Yes

The device is intended for the qualitative detection of gastrointestinal colonization with vancomycin-resistant Enterococcus faecium and Enterococcus faecalis (VRE) to aid in the prevention and control of VRE in healthcare settings, which is a diagnostic purpose even though it explicitly states it is "not intended to diagnose VRE infection or to guide or monitor treatment for infections." The act of detecting colonization itself is a form of diagnosis for the presence of the organism.

SaMD (Software as a Medical Device)

No

The device is a chromogenic culture medium, which is a physical substance used in laboratory testing, not a software program.

IVD (In Vitro Diagnostic)

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 of gastrointestinal colonization with vancomycin-resistant Enterococcus faecium and Enterococcus faecalis (VRE) to aid in the prevention and control of VRE in healthcare settings." This involves testing human specimens (rectal swab and fecal specimens) to obtain information about a patient's health status (colonization with VRE).
Specimen Type: It uses human specimens (rectal swab and fecal specimens).
Purpose: The purpose is to provide information about the presence of VRE colonization, which is used in a healthcare setting for prevention and control.

These characteristics align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Remel Spectra™ VRE is a selective and differential chromogenic medium, containing 6 µg/ml of vancomycin, intended for use in the qualitative detection of gastrointestinal colonization with vancomycin-resistant Enterococcus faecium and Enterococcus faecalis (VRE) to aid in the prevention and control of VRE in healthcare settings. The test is performed with rectal swab and fecal specimens from patients to screen for VRE colonization. Spectra™ VRE is not intended to diagnose VRE infection or to guide or monitor treatment for infections. Subculture to non-selective media (e.g. Tryptic Soy Agar with 5% sheep blood) is needed for further identification, susceptibility testing, and epidemiological typing.

Product codes

LDI

Device Description

Remel Spectra™ VRE is an opaque medium allowing differentiation of vancomycin-resistant E. faecium from vancomycin-resistant E. faecalis by incorporation of two chromogens that are targeted by phosphatase and agalactosidase. The action of these enzymes on the chromogens results in a build-up of color within the colony. The presence of phosphatase enzymes in both E. faecium and E. faecalis results in a light blue or blue colony. However, E. faecium also produces a-galactosidase, resulting in a mix of blué and pink chromophores within the bacterium producing navy blue or pink-purple colonies, which are distinquished from the light blue or blue E. faecalis colonies. Additional antibiotics. in combination with vancomycin, are present to suppress the growth of competing flora including E. gallinarum and E. casseliflavus, both of which are intrinsically resistant to vancomycin, possessing the chromosomally encoded VanC resistance mechanism.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

gastrointestinal

Indicated Patient Age Range

Not Found

Intended User / Care Setting

healthcare settings

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 Accuracy: The performance of Spectra™ VRE was evaluated at three geographically diverse regions of the United States. A total of six hundred twenty-three (623) prospective rectal swab and fecal surveillance specimens (yielding 629 data points) were evaluated. Results from Spectra™ VRE at 24 hours incubation were compared to results obtained from traditional culture on Bile Esculin Azide Agar with 6 µg/ml Vancomycin (BEAV) after 48 hours incubation. Two hundred twenty VRE with minimal inhibitory concentration MICs to vancomycin of >256 µg/ml were recovered from six hundred twenty three specimens (191 vancomycin-resistant E. faecium and 29 vancomycin-resistant E. faecalis). The overall recovery of VRE on Spectra™ VRE at 24 hours was 99.1% (218/220) compared to recovery of 95.5% (210/220) on BEAV at 48 hours. Suspect isolates of VRE were evaluated using the Vitek® 2 system and biochemical tests, and an antibiotic gradient method for determination of vancomycin MIC. For detection of VRE by colored colonies isolated on Spectra™ VRE at 24 hours compared to identification and susceptibility testing as described. the overall agreement was 99.5% (626/629).

Reproducibility: Reproducibility testing was conducted at four sites on three separate days with twenty blinded strains including vancomycin susceptible and resistant E. faecium and E. faecalis, as well as quality control reference strains. The strains produced the expected result with Spectra™ VRE 100% of the time at 24 hours.

Key Metrics

Spectra™ VRE vs. conventional methods: Positive % Agreement 99.1% (218/220) (95% CI = 96.8-99.9%), Negative % Agreement 99.8% (408/409) (95% CI = 98.6-100%).
VR-E. faecium: Positive % Agreement 99.0% (189/191) (95% CI = 96.3-99.9%), Negative % Agreement 99.8% (437/438) (95% CI = 98.7-100%).
VR-E. faecalis: Positive % Agreement 100% (29/29) (95% CI = 88.1-100%), Negative % Agreement 100% (600/600) (95% CI = 99.4-100%).
Overall agreement with commercially available devices: 82.7% (520/629).
Recovery of VRE (acquired resistance) on Bile Esculin Azide with 6 ug/ml Vancomycin: 95.5% (210/220).
Agreement for non-VRE on Bile Esculin Azide with 6 ug/ml Vancomycin: 75.8% (310/409).

Predicate Device(s)

Remel Bile Esculin Azide Aqar with 6 uq/ml Vancomycin

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 866.1700 Culture medium for antimicrobial susceptibility tests.

(a)
Identification. A culture medium for antimicrobial susceptibility tests is a device intended for medical purposes that consists of any medium capable of supporting the growth of many of the bacterial pathogens that are subject to antimicrobial susceptibility tests. The medium should be free of components known to be antagonistic to the common agents for which susceptibility tests are performed in the treatment of disease.(b)
Classification. Class II (performance standards).

Summary

0

K092819

510(k) SUMMARY

Contact Information: Mary Ann Silvius Director. New Product & Business Development Microbiology North America Thermo Fisher Scientific Remel Products 12076 Santa Fe Drive Lenexa. KS 66215 Phone: (913) 895-4054 Fax: (913) 895-4054 email: maryann.silvius@thermofisher.com

JUL 1 5 2010

Date Prepared: September 11, 2009
Device Trade Name: Spectra™ VRE
Predicate Device: Remel Bile Esculin Azide Aqar with 6 uq/ml Vancomycin

Device Classification: 21 CFR 866.1700: Culture medium for antimicrobial susceptibility tests.

Remel Spectra™ VRE is a selective and differential Intended Use: chromogenic medium, containing 6 µg/ml of vancomycin, intended for use in the qualitative detection of gastrointestinal colonization with vancomycin-resistant Enterococcus faecium and Enterococcus faecalis (VRE) to aid in the prevention and control of VRE in healthcare settings. The test is performed with rectal swab and fecal specimens from patients to screen for VRE colonization. Spectra™ VRE is not intended to diagnose VRE infection or to guide or monitor treatment for infections. Subculture to non-selective media (e.g. Tryptic Sov Agar with 5% sheep blood) is needed for further identification. susceptibility testing, and epidemiological typing.
Device Description: Remel Spectra™ VRE is an opaque medium allowing differentiation of vancomycin-resistant E. faecium from vancomycin-resistant E. faecalis by incorporation of two chromogens that are targeted by phosphatase and agalactosidase. The action of these enzymes on the chromogens results in a build-up of color within the colony. The presence of phosphatase enzymes in both E. faecium and E. faecalis results in a light blue or blue colony. However, E. faecium also produces a-galactosidase, resulting in a mix of blué and pink chromophores within the bacterium producing navy blue or pink-purple colonies, which are distinquished from the light blue or blue E. faecalis colonies. Additional antibiotics. in combination with vancomycin, are present to suppress the growth of competing flora including E. gallinarum and E. casseliflavus, both of which are intrinsically resistant to vancomycin, possessing the chromosomally encoded VanC resistance mechanism.

1

Device Comparison:

| Characteristic | Remel Spectra™ VRE | Remel Bile Esculin
Azide with Vancomycin |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | Remel Spectra™ VRE is a selective and
differential chromogenic medium,
containing 6 µg/ml of vancomycin,
recommended for use in the qualitative
detection of gastrointestinal colonization of
vancomycin-resistant Enterococcus (VRE)
to aid in the prevention and control of VRE
in healthcare settings. The test is
performed with rectal swabs and fecal
specimens from patients to screen for VRE
colonization. Spectra™ VRE is not
intended to diagnose VRE infection or to
guide or monitor treatment for infections.
Subculture to non-selective media (e.g.
Tryptic Soy Agar with 5% sheep blood) is
needed for further identification,
susceptibility testing, and epidemiological
typing. | Remel Bile Esculin Azide Agar
w/ 6 µg/ml Vancomycin is a
solid medium recommended for
use in qualitative procedures as
a screening method for primary
isolation and presumptive
identification of vancomycin-
resistant enterococci (VRE)
from surveillance cultures. |
| Inoculation | Direct Specimen | Direct Specimen |
| Sample Type | Fecal specimens
Rectal swabs | Fecal Specimens
Urine specimens |
| Interpretation | Manual, visual | Manual, visual
Additional confirmation required |
| Test
Methodology | Enzymatic | Enzymatic |
| Incubation | 24 hours | 24-48 hours |
| Differences | | |
| Target
Enzyme | Phosphatase
α-galactosidase | Esculin hydrolysis |
| Species
Differentiation | Positive - Vancomycin-resistant E. faecium
colonization: Navy blue or purple-pink
colonies.
Positive - Vancomycin-resistant E. faecalis
colonization: Light blue to blue colonies.
Negative - No VRE colonization: No
colored colonies | Positive - Dark brown to black
color around colonies and
diffusing into the medium.
Negative - No blackening of the
media. |

Summary of Performance Data:

Clinical Accuracy:

The performance of Spectra™ VRE was evaluated at three geographically diverse regions of the United States. A total of six hundred twenty-three (623) prospective rectal swab and fecal surveillance specimens (yielding 629 data points) were evaluated. Results from Spectra™ VRE at 24 hours incubation were compared to results obtained from traditional culture on Bile Esculin Azide Agar with 6 µg/ml Vancomycin (BEAV) after 48 hours incubation. Two hundred twenty VRE with minimal inhibitory concentration MICs to vancomycin of >256 µg/ml were recovered from six hundred twenty three specimens (191 vancomycin-resistant E. faecium and 29

2

vancomycin-resistant E. faecalis). The overall recovery of VRE on Spectra™ VRE at 24 hours was 99.1% (218/220) compared to recovery of 95.5% (210/220) on BEAV at 48 hours.

Suspect isolates of VRE were evaluated using the Vitek® 2 system and biochemical tests, and an antibiotic gradient method for determination of vancomycin MIC. For detection of VRE by colored colonies isolated on Spectra™ VRE at 24 hours compared to identification and susceptibility testing as described. the overall agreement was 99.5% (626/629).

	Positive % Agreement	Negative % Agreement
Spectra™ VRE vs.
conventional methods	99.1%	99.8%
	(218/220)	(408/409)
	(95% CI = 96.8-99.9%)	(95% CI = 98.6-100%)

Note : CI = Confidence Interval

Forty rectal swabs (eleven positive and twenty-eight negative) were tested which did not yield a statistically sound 95% lower bound confidence interval. The results are not included in the data.

Spectra™ VRE vs. Conventional Methods

	Positive % Agreement	Negative % Agreement
VR-E. faecium	99.0%
(189/191)a
(95% CI = 96.3-99.9%)	99.8%
(437/438)b
(95% CI = 98.7-100%)
VR-E. faecalis	100%
(29/29)
(95% CI = 88.1-100%)	100%
(600/600)
(95% CI = 99.4-100%)

Note : Cl = Confidence Interval

4 One isolate showed expected results at 28 hours and one isolate showed expected results at 48 hours.

6 One isolate developed pink colonies and was identified as Lactobacillus sp.

Performance Compared to Commercially Available Devices:

Spectra™ VRE was compared to culture on Bile Esculin Azide with 6 ug/ml Vancomycin, with subsequent identification and susceptibility testing. There was 82.7% (520/629) agreement with six hundred twenty-nine isolates. The Bile Esculin Azide with 6 ug/ml Vancomycin demonstrated 95.5% (210/220) agreement for the recovery of VRE (acquired resistance) and 75.8% (310/409) agreement for non-VRE.

Interfering Substances:

The following substances were evaluated for potential interference of the chromogenic reaction of Spectra™ VRE. These substances were tested in combination with vancomvcinresistant E. faecalis and E. faecium isolates at a concentration of 50 CFU: blood, mucous, MYLANTA® Maximum Strength, Pepto-Bismol®, Imodium® A-D, Kaopectate®, Fletcher's Castoria®, PEPCID® AC Maximum Strength, Tagamet HB 200®, Prilosec OTC®, vancomycin, metronidazole, barium sulfate, Preparation Ho, petroleum jelly, glycerin, bisacodyl, witch hazel, miconazole, nonoxynol-9, KY® Jelly. Hydrocortisone acetate was not evaluated. Blood, Pepto-Bismol®, glycerin, vancomycin, miconazole, and Preparation H® may reduce the recovery of vancomycin resistant E. faecalis and E. faecium strains.

Reproducibility:

Reproducibility testing was conducted at four sites on three separate days with twenty blinded strains including vancomycin susceptible and resistant E. faecium and E. faecalis, as well as quality control reference strains. The strains produced the expected result with Spectra™ VRE 100% of the time at 24 hours.

3

Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

JUL 15 2010

ThermoFisher SCIENTIFIC Remel Products c/o Mary Ann Silvius Director, New Product & Business Development Microbiology North America 12076 Santa Fe Drive Lenexa, KS 66215

Re: K092819

Trade/Device Name: Spectra™ VRE Regulation Number: 21 CFR § 866.1700 Regulation Name: Remel Spectra™ VRE Chromogenic VRE Media Regulatory Class: Class II Product Code: . 180 Dated: July 13, 2010 Received: July 14, 2010

Dear Ms. Silvius

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, ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

4

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97).

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Saga Agona

Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

5

INDICATIONS FOR USE

510(k) Number (if known): K092819

Device Name: Spectra™ VRE

Indications For Use: Remel Spectra™ VRE is a selective and differential chromogenic medium, containing 6 µg/ml of vancomycin, intended for use in the qualitative detection of gastrointestinal colonization with vancomycin-resistant Enterococcus faecium and Enterococcus faecalis (VRE) to aid in the prevention and control of VRE in healthcare settings. The test is performed with rectal swab and fecal specimens from patients to screen for VRE colonization. Spectra™ VRE is not intended to diagnose VRE infection or to guide or monitor treatment for infections. Subculture to non-selective media (e.g. Tryptic Soy Agar with 5% sheep blood) is needed for further identification, susceptibility testing, and epidemiological typing.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ludolite. Rooly

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k)