The QUANTA Lite™ h-tTG Screen is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of IgA and IgG antibodies to human tissue transglutaminase (htTG) in human serum. The presence of these antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of both IgA sufficient and IgA deficient celiac disease as well as dermatitis herpetiformis.

Device Description

Each device contains the following: polystyrene microplate strips with breakaway (12 (1x8) microwells coated with human tissue transglutaminase antigen with holder; high positive, low positive and negative controls (human serum); HRP wash concentrate; HRP sample diluent; HRP IgG and IgA (goat) anti-human conjugate; TMB chromogen; and HRP stop solution (0.344M sulfuric acid).

AI/ML Overview

Below is the information regarding the acceptance criteria and the study proving the device meets those criteria, extracted from the provided text.

QUANTA Lite™ h-tTG Screen

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria with pass/fail thresholds in a table format. However, it reports performance characteristics that serve as the basis for a substantial equivalence decision. These are presented below, along with the device's reported performance. The implied acceptance is that these values demonstrate performance comparable to the predicate devices and are clinically acceptable for the intended use.

Performance Metric	Reported Device Performance (QUANTA Lite™ h-tTG Screen)
Analytical Performance
Intra-Assay Precision (high conc.)	%CV: 1.2-7.7% (32.6-46.8 units)
Intra-Assay Precision (near cut-off)	%CV: 2.1-5.8% (18.3-22.3 units)
Intra-Assay Precision (negative)	%CV: 5.6-7.2% (7.7-13.5 units)
Inter-Assay Precision (high conc.)	%CV: 2.2-9.3% (31.3-49.3 units)
Inter-Assay Precision (near cut-off)	%CV: 4.8-11.3% (16.0-23.0 units)
Inter-Assay Precision (negative)	%CV: 6.1-18.4% (5.2-14.5 units)
Assay Specificity (healthy individuals)	97.9% (373/381)
Cut-off value	20.0 units
Cross-reactivity (other autoantibodies)	All 44 samples negative (mean value 4.6 U/mL)
Method Comparison with Predicate
Positive Percent Agreement (PPA)	100.0% (52/52)
Negative Percent Agreement (NPA)	97.1% (451/454)
Overall Agreement	97.4% (493/506)
Clinical Performance
Clinical Sensitivity	87.8% (36/41)
Clinical Specificity	97.1% (462/476)

2. Sample size used for the test set and the data provenance

Analytical Performance (Assay Cut-off): 381 random asymptomatic healthy individuals residing in the United States.
Method Comparison with Predicate Device: 506 samples in total. This included 125 samples from four celiac disease reference labs and 81 normal samples. The document doesn't explicitly state the country of origin for all samples beyond "United States" for the assay cut-off derivation. The study is retrospective, utilizing existing samples.
Clinical Sensitivity and Specificity: 517 clinically defined samples. This included 23 Celiacs untreated, 5 Celiac IgA Deficient, 18 Celiac 1st degree relatives, 13 Dermatitis Herpetiformis, 44 Disease Controls, and 414 Healthy individuals. The provenance is implied to be from a clinical setting, likely retrospective as samples are "clinically defined."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not specify the number of experts used or their qualifications for establishing the ground truth for the test set.

4. Adjudication method for the test set

The document does not describe an adjudication method (e.g., 2+1, 3+1) for the test set in the context of expert review. Clinical diagnoses and reference lab results likely served as the ground truth.

5. 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

This is an ELISA-based diagnostic assay for antibodies, not an imaging or interpretive device that would typically involve human "readers" or an "AI assistant" in the sense of an MRMC study. Therefore, no MRMC comparative effectiveness study was done, and terms like "human readers improve with AI" are not applicable here. The device itself is an automated test.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the performance data presented (precision, assay specificity, method comparison, clinical sensitivity/specificity) reflects the standalone performance of the QUANTA Lite™ h-tTG Screen ELISA assay. It's a laboratory test, not an AI algorithm, and its output (semi-quantitative detection of antibodies) is the direct result of the assay, to be interpreted by a healthcare professional.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Assay Cut-off: Derived from 381 asymptomatic healthy individuals, implying a ground truth of "absence of disease" or "normal" based on clinical status. One "strong positive" sample showing a value of 54.9 units was "believed to be from a true celiac patient based on a positive IgA anti-h-tTG result of 72.4 units," indicating a combination of existing diagnostic results and clinical judgment.
Method Comparison: Ground truth was established by comparing against predicate devices (QUANTA Lite™ h-tTG IgA and QUANTA Lite™ h-tTG IgG) and samples from "four celiac disease reference labs." This indicates ground truth based on established laboratory methods and clinical diagnoses from reference centers.
Clinical Sensitivity and Specificity: Ground truth was based on "clinically defined samples" with diagnoses such as "Celiacs untreated," "Celiac IgA Deficient," "Dermatitis Herpetiformis," "Disease Controls," and "Healthy individuals." This suggests a reliance on clinicians' diagnoses, potentially supported by other tests, pathology (e.g., biopsy for celiac disease), or expert consensus.

8. The sample size for the training set

The document does not explicitly mention a "training set" in the context of machine learning. For an ELISA assay, the equivalent of a training set would be samples used during the development and optimization of the assay, including optimization of reagents, reaction conditions, and establishment of controls and calibrators. The document mentions that "positive and negative controls are prepared in-house and arbitrary units are assigned during the development process," which would involve a set of samples, but a specific "sample size for the training set" is not provided.

9. How the ground truth for the training set was established

As noted above, a formal "training set" with ground truth in the machine learning sense is not applicable. For the development process (equivalent to "training"), ground truth for controls was established by preparing them "in-house." For assay development and optimization, various samples (e.g., known positive, known negative) would have been used. The "assay cut-off" was established from 381 healthy individuals, providing a benchmark for defining "negative." Clinical samples with established diagnoses would have been used to guide the development of an assay that accurately reflects disease status. However, the specific details of ground truth establishment for all developmental samples are not provided.

Summary

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FEB 1 2 2008

K073/45

510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

K073145 B. Purpose for Submission: New device C. Measurand: Anti-human tissue transglutaminase (htTG) IgG and IgA antibodies D. Type of Test: Semi-quantitative ELISA E. Applicant: NOVA Diagnostics, Inc. F. Proprietary and Established Names: QUANTA Lite™ h-tTG Screen

G. Regulatory Information:

1. Regulation section: 21 CFR § 866.5660 Multiple autoantibodies immunological test systems
1. Classification: Class II

A. 510(k) Number:

1. Product codes: MVM, Autoantibodies, Endomysial (Tissue Transglutaminase) 4. Panel:
  Immunology 82

H. Intended Use:

1. Intended use(s):
  The QUANTA Lite™ h-tTG Screen is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of IgA and IgG antibodies to human tissue transglutaminase (htTG) in human serum. The presence of these antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of both IgA sufficient and IgA deficient celiac disease as well as dermatitis herpetiformis
1. Indication(s) for use:
- Same as Intended use.
Special conditions for use statement(s): 3. For prescription only.
1. Special instrument requirements: Microplate reader capable of measuring OD at 450 nm (or 650 for dual wavelength readings)

I. Device Description:

J. Substantial Equivalence Information:

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1. Predicate device name(s): QUANTA Lite™ h-tTG IgA
  QUANTA Lite™ h-tTG IgG

Predicate K number(s):

K011566 (h-tTG IgA) K011570 (h-tTG IgG)
1. Comparison with predicate:

Similarities
Item	New Device	Predicate Device
	QUANTA Lite™ h-tTG Screen	QUANTALite™ h-tTGIgAQUANTALite™ h-tTGIgG
Technology	ELISA	Same
Antigen	Purified h-tTG antigen	Same
Measurement	Semi-quantitative	Same
Assay Platform	96 well microtiter plate	Same
Sample type anddilution	Serum at 1:101	Same
Sample volumerequired	5 μL	Same
Low Positive, Highpositive andNegative Control	Pre-diluted humanserum. Ready to use.	Same
Diluent	HRP sample diluent	Same
HRP Washconcentrate	40X	Same
Substrate	TMB Chromogen	Same
HRP Stop solution	0.344M Sulfuric Acid	Same
Assay washing step	Two steps	Same
Incubation times	30-30-30 minutes	Same
SpectrophotometricOD Reading	450nm (or 620 for dualwavelength)	Same
Detection Method	Colorimetric	Same
Cut-off	20.0 units	Same

Item	Device	Predicate
Intended use	QUANTA Lite™h-tTG Screen	QUANTA Lite™h-tTG IgA	QUANTA Lite™h-tTG IgG
	For the semi-quantitativedetection of IgAand IgG antibodiesto human tissuetransglutaminase	For the semi-quantitativedetection of IgAantibodies totissuetransglutaminase	For the semi-quantitativedetection IgGantibodies totissuetransglutaminase

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Item	Device	Predicate
	(htTG) in human serum.	(endomysium) in human serum.
Indications for Use	Aid in the diagnosis of both IgA sufficient and IgA deficient celiac disease as well as dermatitis herpetiformis	Aid in the diagnosis of certain gluten sensitive enteropathies such as celiac disease and dermatitis herpetiformis
		Aid in the diagnosis of certain gluten sensitive enteropathies such as celiac disease and dermatitis herpetiformis. This test is intended for providing added sensitivity when testing IgA deficient patients
Enzyme Conjugate	Horseradish Peroxidase, Goat anti-human IgA and IgG	Horseradish Peroxidase, Goat anti-human IgA
		Horseradish Peroxidase, Goat anti-human IgG
Result Interpretation	Neg = $<$ 20 UnitsPos = $≥$ 20 Units	Neg = $<$ 20 UnitsWk Pos = 20 -30Mod to Strong Positive = $>$ 30
		Neg = $<$ 20 UnitsWk Pos = 20 -30Mod to Strong Positive = $>$ 30

K. Standard/Guidance Document Referenced (if applicable):

CLSI (NCCLS) H18-A3 Sample storage conditions and CLSI (NCCLS) C24-A3 Appropriate Quality Control Practices.

L. Test Principle:

Native human tissue transglutaminase is bound to the wells of a polystyrene microwell plate under conditions that will preserve the antigen in its native state. Prediluted controls and diluted patient sera are added to separate wells, allowing any htTG IgA or IgG antibodies present to bind to the immobilized antigen. Unbound sample is washed away and an enzyme labeled anti-human IgA and IgG conjugate is added to each well. A second incubation allows the enzyme labeled anti-human IgA and IgG to bind to any patient antibodies, which have become attached to the microwells. After washing away any unbound enzyme labeled anti-human IgA and IgG, the remaining enzyme activity is measured by adding a chromogenic substrate and measuring the intensity of the color that develops. The assay can be evaluated spectrophotometrically by measuring and comparing the color intensity that develops in the patient wells with the color in the control wells

M. Performance Characteristics (if/when applicable):

1. Analytical performance:
- a. Precision/Reproducibility:

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The intra-assay precision was determined by testing nine serum samples five times on one kit lot by one operator. Results showed that 4 samples with high anti-h-tTG concentrations (32.6-46.8 units) had %CV of 1.2-7.7%. 3 samples close to the cut-off (18.3-22.3 units) had % CV of 2.1-5.8% and 2 negative samples (7.7-13.5 units) had %CV of 5.6-7.2% (see table below).

Sample		1
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CT		. .	œ- 9 had	. .
C10	.			1	A B AR A C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C	CONTRACTOR A CARREN & CLANDLE & CONTRACT AND	1C

Intra-assay Performance of QUANTA Lite™ h-tTG Screen ELISA

The inter-assay precision was determined by testing twelve serum samples in duplicate six times for five days on one kit lot by one operator. Results showed that 5 samples with high anti-h-tTG concentrations (31.3-49.3 units) had %CV of 2.2-9.3%, 3 samples close to the cut-off (16.0-23.0 units) had % CV of 4.8-11.3% and 4 negative samples (5.2-14.5units) had %CV of 6.1-18.4% (see table below).

Inter-assay Performance for QUANTA Lite™ h-tTG Screen ELISA

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b. Linearity/assay reportable range: Not applicable.
Traceability, Stability, Expected values (controls, calibrators, or methods): C. There are no reference standards for htTG. The positive and negative controls are prepared in-house and arbitrary units are assigned during the development process.

Stability: The expiration date claim is one year for the QUANTA Lite™ htTG Screen.

d. Detection limit:
Not applicable.
Analytical specificity: e.
Interference by endogenous substances: No data provided. The package insert states that grossly hemolyzed, lipemic, icteric, microbially contaminated, heattreated samples or specimens containing visible particulate should be avoided in this assay.

Crossreactivity with other autoantibodies: The QUANTA Lite™ h-tTG Screen was tested with 44 sera containing other autoantibodies specific for:

Chromatin (4), Centromere (4), GBM (4), SS-B (4), RNP (5), SCL-70 (6), Jo-1 (5), Sm (4), SS-A (4), and TPO (4). All samples were negative with the QUANTA Lite"" h-tTG Screen with a mean value of 4.6 U/mL which is below

the 20 unit cut-off.

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f. Assav cut-off:
The assay cut-off of 20 units for the assay was established from 381 random asymptomatic healthy individuals residing in the United States. Age and gender were available for 269 samples and unavailable for the remaining 112 samples. The age ranges were 14-76 years and included 141 male subjects and 128 female subjects. The assay specificity was 97.9% (373/381). The mean value of 381 samples was 8.6 units. The standard deviation (SD) of the samples was 4.4 units. The mean value was 2.5SDs below the cut-off value of 20 units. Of the 8 positive samples, six were weak positive with values from 20.3 - 28.4 units; one moderate positive value was 32.4 units and one strong positive value was 54.9 units which was believed to be from a true celiac patient based on a positive IgA anti-h-tTG result of 72.4 units.
1. Comparison studies:
- a. Method comparison with predicate device:

Testing was performed on 125 samples from four celiac disease reference labs and 81 normal samples. The Positive Percent Agreement was 100.0% (52/52); the Negative Percent Agreement was 97.1% (451/454) and the Overall Agreement was 97.4% (493/506).

		QUANTA Lite TM h-tTG IgA or IgG
		Positive	Negative	Total
QUANTALiteTM h-tTGScreen	Positive	52	13*	65
QUANTALiteTM h-tTGScreen	Negative	0	441	441
QUANTALiteTM h-tTGScreen	Total	52	454	506

- Of the 13 samples found to be h-tTG Screen positive, yet negative on both h-tTG IgA and h-tTG IgG kits, 3 from celiac patients on GFDs, two from 1st degree relatives, and eight from apparently healthy subjects. All 13 samples had values under 30 units.
b. Matrix comparison:

Serum is the only recommended matrix.

1. Clinical studies:
- Clinical Sensitivity and specificity: a.

The clinical sensitivity and specificity study were evaluated on 517 clinically defined samples from patients with the following diagnosis: 23 Celiacs untreated, 5 Celiac IgA Deficient, 18 Celiac 1st degree relatives, 13 Dermatitis Herpetiformis, 44 Disease Controls, and 414 Healthy individuals. The QUANTA Lite™ h-tTG Screen assay sensitivity and specificity were 87.8% (36/41) and 97.1% (462/476) respectively (refer to table below).

		Diagnosis
		Positives(Celiacs untreatedand IgA deficient)	Negative(1st degree relatives, DiseaseControls and Healthy Controls)	Totals
QUANTALITE™ h-tTGScreen	Positive	36	14	50
QUANTALITE™ h-tTGScreen	Negative	5	462	467
QUANTALITE™ h-tTGScreen	Total	41	476	517

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In addition, a summary of the results for the individual diagnosis is listed below:

	Diagnosis	n	Positive h-tTG Screen	% Sensitivity
PatientGroups	Celiacs untreated	23	23	100%
	Celiac IgA Deficient	5	4	80%
	Celiacs on Gluten-Free Diet	33*	15	45%
	1st degree relatives	18	4	22%
	Dermatitis Herpetiformis	13	9	69%
	Disease Controls	44	0	0%
Normals		414	10**	2.4%

*33 GFD Celiacs were excluded from the previous sensitivity/ specificity table.

** 1 of the 10 positives was found to be positive on individual h-tTG ELISA assays and also positive for tTG by fluid phase RIA.

b. Other clinical supportive data (when a. is not applicable): Not applicable.
1. Clinical cut-off:

Same as assay cut-off.

1. Expected values/Reference range:
  Expected values in the normal population should be negative.

N. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

O. Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circle around the symbol. The caduceus is a common symbol associated with healthcare and medicine.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 1 2 2008

INOVA Diagnostics, Inc. c/o Mr. Joseph Phillips Group Lead Development 9900 Old Grove Rd. San Diego, CA 92131-1638

Re: K073145

Trade/Device Name: QUANTA Lite™ h-tTG Screen Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple autoantibodies immunological test system Regulatory Class: Class II Product Code: MVM Dated: February 5, 2008 Received: February 6, 2008

Dear Mr. Myers:

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.

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The

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Page 2 -

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) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Robert H. Becker

Robert L. Becker, Jr., M.D., Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K073145

Device Name: QUANTA Lite™ h-tTG Screen

Indications for Use:

The QUANTA Lite™ h-tTG Screen is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of IgA and IgG antibodies to human tissue transglutaminase (h-tTG) in human serum. The presence of these antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of both IgA sufficient and IgA deficient celiac disease as well as dermatitis herpetiformis.

Prescription Use ਮ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Marci M Chan
Division Sign-Off

Division sign on

Office of in Vitro Diagnostic Device Evaluation and Safety Page 1 of

510kK073/45

Regulation Number and Section

§ 866.5660 Multiple autoantibodies immunological test system.

(a)
Identification. A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).(b)
Classification. Class II (performance standards).