The CEDIATM Heroin Metabolite (6-AM) Assay is a homogeneous enzyme immunoassay for the in vitro qualitative and or semi-quantitative determination of the presence of heroin metabolite (6-AM) in human urine at a cut-off concentration of 10 ng/mL. The assay is intended to be used in laboratories and provides a rapid analytical screening procedure to detect 6-Acetylmorphine in human urine. The assay is designed for use with a number of clinical chemistry analyzers. This product is intended to be used by trained professionals only.

The semi-quantitative mode is for the purpose of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Liquid Chromatography/tandem mass spectrometry (LC-MS/MS) or permitting laboratories to establish quality control procedures.

The assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/ mass spectrometry (GC/MS) or Liquid chromatography with tandem mass spectrometry (LC-MS/MS) is the preferred confirmatory method.

Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used. For In Vitro Diagnostic Use Only.

Device Description

CEDIA technology uses recombinant DNA technology to produce a unique homogeneous enzyme immunoassay system. The assay is based on the bacterial enzyme ßgalactosidase, which has been genetically engineered into two inactive fragments. These fragments spontaneously re-associate to form fully active enzymes that, in the assay format, cleave a substrate. This generates a color change that can be measured spectrophotometrically.

CEDIA™ Heroin Metabolite (6-AM) Assay is supplied as a two liquid and two lyophilized reagent kit homogeneous enzyme immunoassay. The assay uses an antibody that is specific for 6-Acetylmorphine and cross reacts with Heroin. The assay has minimal cross reactivity to structurally related and unrelated compounds. In the assay, analyte in the sample competes with analyte coniugated to one inactive fragment of B-galactosidase for antibody binding site. If analyte is present in the sample, it binds to antibody, leaving the inactive enzyme fragments free to form active enzyme. If analyte is not present in the sample, antibody binds to analyte conjuqated on the inactive fragment, inhibiting the reassociation of inactive ß- galactosidase fragments, and no active enzyme is formed. The amount of active enzyme formed and resultant absorbance change are directly proportional to the amount of drug present in the sample.

AI/ML Overview

The provided FDA 510(k) summary for the Microgenics Corporation CEDIA™ Heroin Metabolite (6-AM) Assay (K231007) does not contain the detailed information necessary to fully address all aspects of your request. This document is a summary of the device's substantial equivalence to a predicate device, not a complete study report.

Specifically, the document does not contain details regarding the study design, sample sizes for test and training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance. The studies mentioned are focused on analytical performance characteristics (precision, spike recovery, dilution linearity, method comparison, specificity, stability) relevant to an in vitro diagnostic assay, rather than a typical AI/ML device assessment.

However, I can extract the available information regarding acceptance criteria and reported device performance:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria	Reported Device Performance
Precision	Qualitative/Semi-quantitative Mode: ≥ 95% of samples below the cutoff read as negative and ≥ 95% of samples above the cutoff read as positive.	Qualitative Mode: "All 20 replicates of spiked 7.5 ng/mL and 12.5 ng/mL samples are detected as Negative and Positive, respectively, when compared to 10 ng/mL spiked sample." (This implies 100% agreement, exceeding the ≥ 95% criterion for these specific concentrations.)Semi-quantitative Mode: "The spiked samples recover within 80–120% of the nominal values."
Spike Recovery	Qualitative Mode: No ± 2SD overlap between 10 ng/mL, 7.5 ng/mL, and 12.5 ng/mL samples. All 20 replicates of spiked 7.5 ng/mL and 12.5 ng/mL samples detected as Negative and Positive, respectively, compared to 10 ng/mL.	Qualitative Mode: "All 20 replicates of spiked 7.5 ng/mL and 12.5 ng/mL samples are detected as Negative and Positive, respectively, when compared to 10 ng/mL spiked sample." (Meets criteria)
Dilution Linearity	Linearity throughout the calibration range of 0 to 20 ng/mL with R > 0.99. Mean recovery at each level within 80-120% of expected values.	"The assay demonstrates linearity throughout the calibration range of 0 to 20 ng/mL and R > 0.99. The mean recovery at each level is within 80-120% of expected values." (Meets criteria)
Method Comparison	Not explicitly stated as "acceptance criteria", but implied good agreement is required.	Qualitative Mode: 100% negative agreement, 100% positive agreement, 100% overall correlation agreement.Semi-quantitative Mode: 98.4% negative agreement, 98.3% positive agreement, 98.4% overall correlation agreement.
Specificity (Cross-Reactivity)	Minimal cross-reactivity with structurally related and unrelated compounds.	"The assay is specific for 6-Acetylmorphine and demonstrates cross-reactivity to heroin. Minimal cross-reactivity is observed with other structurally related and unrelated compounds." (Meets criteria)
Specificity (Interference)	No significant interference from endogenous and exogenous substances at tested concentrations, and within pH 3-11 and specific gravity 1.000-1.030.	"Results demonstrate that there is no significant interference from the endogenous and exogenous substances in human urine at the tested concentrations, in samples within pH range of 3-11 and in samples with specific gravity within 1.000-1.030." (Meets criteria)
Stability (Reagents)	Supports claim of 60 days on-board, 60 days reconstituted, and 60 days open vial. Proposed shelf-life of 24 months.	Reagent On-Board: Supports 60 days for qualitative and semi-quantitative modes.Reconstituted Reagent: Supports 60 days for qualitative and semi-quantitative modes.Open Vial: Supports 60 days for qualitative and semi-quantitative modes (data from K192943).Real Time: Supports 24 months shelf-life (data from K192943).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size:
- For Precision / Spike Recovery in Qualitative Mode: "All 20 replicates of spiked 7.5 ng/mL and 12.5 ng/mL samples" were used. This indicates 20 replicates for each of these two concentrations, plus presumably samples for the 10 ng/mL cutoff for comparison. The total number of individual samples is not explicitly stated beyond these replicates for specific concentrations.
- For Method Comparison: No specific number for the test set is provided, only percentages of agreement.
- For Specificity (Interference): "tested concentrations" are mentioned, but the number of samples is not provided.
- For Reagent Stability: "one lot" for on-board, reconstituted, and open vial stability, and "three lots" for real-time stability.
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The studies appear to be laboratory-based analytical performance studies. The "human urine" matrix is mentioned, indicating human samples were used.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. For in vitro diagnostic devices like this assay, "ground truth" is typically established through a reference method (e.g., LC-MS/MS or GC/MS for drug levels) not by human experts interpreting images or other complex data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/not provided. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation of medical images or other subjective data where consensus among experts is needed. For an immunoassay, the "ground truth" is determined by a quantitative chemical method, not by expert consensus.

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 information is not applicable/not provided. An MRMC study is relevant for AI-powered diagnostic tools where human readers (e.g., radiologists) interact with or are assisted by the AI. This device is an in vitro diagnostic immunoassay, not an AI imaging or diagnostic algorithm designed to assist human readers.

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

This information is not applicable/not provided in the context of AI algorithms. This device is an immunoassay, and its "standalone performance" is what is described in the precision, spike recovery, dilution linearity, and specificity sections. It's an automated chemical analysis, not an AI algorithm performing a task without human intervention in an AI/ML sense.

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

The document mentions that for confirmation, "A more specific alternative chemical method must be used...Gas chromatography/mass spectrometry (GC/MS) or Liquid chromatography with tandem mass spectrometry (LC-MS/MS) is the preferred confirmatory method." This indicates that confirmatory chemical analysis (LC-MS/MS or GC/MS) serves as the "ground truth" or reference method for determining the presence and concentration of 6-Acetylmorphine in urine samples.

8. The sample size for the training set

This information is not provided. The development of an immunoassay may involve optimization and calibration with a set of samples, but these are typically not referred to as a "training set" in the context of machine learning.

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

This information is not provided. Similar to point 8, the concept of a "training set" and its "ground truth" establishment as used in AI/ML is not directly applicable or documented for this type of in vitro diagnostic device in this summary. The development process would involve optimizing the assay's chemical components and reaction parameters using well-characterized samples.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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.

Microgenics Corporation Amrit Takhar Regulatory Affairs Specialist II 46500 Kato Road Fremont, California 94538

Re: K231007

Trade/Device Name: CEDIA"M Heroin Metabolite (6-AM) Assay Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate Test System Regulatory Class: Class II Product Code: DJG Dated: August 11, 2023 Received: August 15, 2023

Dear Amrit Takhar:

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. 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 located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm 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.

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,

{1}------------------------------------------------

including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-howreport-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,

Joseph A. Kotarek -S

Digitally signed by Joseph A. Kotarek -S Date: 2023.09.27 17:25:56 -04'00'

Joseph Kotarek Toxicology Branch Chief Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K231007

Device Name CEDIATM Heroin Metabolite (6-AM) Assay

Indications for Use (Describe)

Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used. For In Vitro Diagnostic Use Only.

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect

of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510K Summary K231007

Device Information l.

Contact Details
Sponsor:	Microgenics Corporation Thermo FisherScientific 46500 Kato RoadFremont, CA 94538Phone: 510-979-5000FAX: 510-979-5002
Correspondent Contact Information:	Amrit TakharRegulatory Affairs Specialist II,Regulatory AffairsEmail: Amrit.Takhar@thermofisher.comPhone: 510-979-5000FAX: 510-979-5002
Device Name
Device Trade Name:	CEDIA™ Heroin Metabolite (6-AM) Assay
Common Name:	Opiate Test System
Classification Name:	Enzyme Immunoassay, Opiates
Regulation Number:	862.3650
Product Code:	DJG
Legally Marketed Predicate Device
Predicate Premarket Notification Number:	K192943
Predicate Trade Name:	CEDIA™ Heroin Metabolite (6-AM) Assay
Predicate Common Name:	Opiate Test System
Predicate Classification Name:	Enzyme Immunoassay, Opiates
Predicate Regulation Number:	862.3650
Predicate Product Code:	DJG

ll. Date Summary Prepared

September 27, 2023

lll. Description of Device

{4}------------------------------------------------

reactivity to structurally related and unrelated compounds. In the assay, analyte in the sample competes with analyte coniugated to one inactive fragment of B-galactosidase for antibody binding site. If analyte is present in the sample, it binds to antibody, leaving the

inactive enzyme fragments free to form active enzyme. If analyte is not present in the sample, antibody binds to analyte conjuqated on the inactive fragment, inhibiting the reassociation of inactive ß- galactosidase fragments, and no active enzyme is formed. The amount of active enzyme formed and resultant absorbance change are directly proportional to the amount of drug present in the sample.

IV. Intended Use

A. Indications for Use:

See indications for use below.

B. Intended Use:

The CEDIA™ Heroin Metabolite (6-AM) Assay is a homogeneous enzyme immunoassay for the in vitro qualitative and/or semi-quantitative determination of the presence of heroin metabolite (6-AM) in human urine at a cut-off concentration of 10 ng/mL. The assay is intended to be used in laboratories and provides a rapid analytical screening procedure to detect 6-Acetylmorphine in human urine. The assay is designed for use with a number of clinical chemistry analyzers. This product is intended to be used by trained professionals only.

The semi-quantitative mode is for the purpose of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Liguid Chromatography/tandem mass spectrometry (LC-MS/MS) or permitting laboratories to establish quality control procedures.

Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used. For In Vitro Diagnostic Use Only.

Candidate Device Predicate Device CEDIA™ Heroin Characteristics CEDIA™ Heroin Comparison Metabolite (6-AM) Assay Metabolite (6-AM) Assay (K192943) See intended use below for See intended use below for Indications for Identical Use indications use indications use

V. Comparison to Predicate Device

{5}------------------------------------------------

Characteristics	Candidate DeviceCEDIATM HeroinMetabolite (6-AM) Assay	Predicate DeviceCEDIATM HeroinMetabolite (6-AM) Assay(K192943)	Comparison
Intended Use	The CEDIATM HeroinMetabolite (6-AM) Assay isa homogeneousenzyme immunoassay forthe in vitro qualitativeand/or semi-quantitativedetermination of thepresence of heroinmetabolite (6-AM) inhuman urine at a cut-offconcentration of 10 ng/mL.The assay is intended to beused in laboratories andprovides a rapid analyticalscreening procedure todetect 6-Acetylmorphine inhuman urine. The assay isdesigned for use with anumber of clinicalchemistry analyzers. Thisproduct is intended to beused by trainedprofessionals only.The semi-quantitativemode is for the purpose ofenabling laboratories todetermine an appropriatedilution of the specimen forconfirmation by aconfirmatory method suchas LiquidChromatography/tandemmass spectrometry (LC-MS/MS) or permittinglaboratories to establishquality control procedures.The assay provides only apreliminary analytical testresult. A more specificalternative chemical	The CEDIATM HeroinMetabolite (6-Acetylmorphine, or 6-AM)Assay is a homogeneousenzyme immunoassay forthe in vitro qualitativeand/or semi-quantitativedetermination of thepresence of heroinmetabolite (6-AM) inhuman urine at a cut-offconcentration of 10 ng/mL.The assay is intended to beused in laboratories andprovides a rapid analyticalscreening procedure todetect 6-Acetylmorphine inhuman urine. The assay isdesigned for use with anumber of clinicalchemistry analyzers. Thisproduct is intended to beused by trainedprofessionals only.The semi-quantitativemode is for the purpose ofenabling laboratories todetermine an appropriatedilution of the specimen forconfirmation by aconfirmatory method suchas LiquidChromatography/tandemmass spectrometry (LC-MS/MS) or permittinglaboratories to establishquality control procedures.The assay provides only apreliminary analytical testresult A more specific	Identical
Characteristics	Candidate DeviceCEDIA™ HeroinMetabolite (6-AM) Assay	Predicate DeviceCEDIA™ HeroinMetabolite (6-AM) Assay(K192943)	Comparison
	method must be used toobtain a confirmedanalytical result. Gaschromatography/massspectrometry (GC/MS) orLiquid chromatography/mass spectrometry (LC-MS/MS) is the preferredconfirmatory method.Clinical and professionaljudgment should be appliedto any drug of abuse testresult, particularly whenpreliminary results areused.For In Vitro Diagnostic UseOnly.	alternative chemicalmethod must be used toobtain a confirmedanalytical result. Gaschromatography/massspectrometry (GC/MS) orLiquid chromatography/mass spectrometry (LC-MS/MS) is the preferredconfirmatory method.Clinical and professionaljudgment should be appliedto any drug of abuse testresult, particularly whenpreliminary results areused.For In Vitro Diagnostic UseOnly.
FDA ProductCode	DJG	DJG	Identical
DeviceClassificationand Name	Class II, 21 CFR 862.3650- Opiate testsystem, 91 – Toxicology	Class II, 21 CFR 862.3650 -Opiate testsystem, 91 – Toxicology	Identical
OperatingPrinciple(Technology)	CEDIA	CEDIA	Identical
Analyte	6-Acetylmorphine	6-Acetylmorphine	Identical
Characteristics	Candidate DeviceCEDIA™ HeroinMetabolite (6-AM) Assay	Predicate DeviceCEDIA™ HeroinMetabolite (6-AM) Assay	Comparison
		(K192943)
MeasuredAnalyte	Heroin and 6-Acetylmorphine	Heroin and 6-Acetylmorphine	Identical
Test Matrix	Human Urine	Human Urine	Identical
Cut-off Levels	10 ng/mL	10 ng/mL	Identical
Methodology	Homogeneous EnzymeImmunoassay	Homogeneous EnzymeImmunoassay	Identical
Materials	Assay contains buffer salts,stabilizer, and preservative,BSA. Assay contains mousemonoclonal anti-6-Acetylmorphine derivativeantibody, Enzyme Acceptor(Escherichia Coli), andEnzyme Donor (EscherichiaColi) Conjugated to 6-Acetylmorphinederivative	Assay contains buffer salts,stabilizer, and preservative,BSA. Assay contains mousemonoclonal anti-6-Acetylmorphine derivativeantibody, Enzyme Acceptor(Escherichia Coli), andEnzyme Donor (EscherichiaColi) Conjugated to 6-Acetylmorphine derivative	Identical
Reagent Form	EA and ED:Lyophilized(Reconstitution Required)EARB and EDRB: Liquidready-to-use	EA and ED: Lyophilized(Reconstitution Required)EARB and EDRB: Liquidready-to-use	Identical
Characteristics	Candidate DeviceCEDIA™ HeroinMetabolite (6-AM) Assay	Predicate DeviceCEDIA™ HeroinMetabolite (6-AM) Assay(K192943)	Comparison
Antibody	Mouse MonoclonalAntibodies	Mouse MonoclonalAntibodies	Identical
Storage	2-8°C until expirationdate	2-8°C until expiration date	Identical
PrincipalOperator	Trained professionals	Trained professionals	Identical
Instrument	Horiba Yumizen C1200	Horiba Pentra C400	DifferentclinicalchemistryAnalyzer

{6}------------------------------------------------

{7}------------------------------------------------

{8}------------------------------------------------

Summary of Performance Testing VI.

A. Precision:

For Qualitative and semi-quantitative mode. ≥ 95% of samples below the cutoff read as neqative and ≥ 95% of samples above the cutoff read as positive.

B. Spike Recovery:

In qualitative mode, there is no ± 2SD overlap between the spiked 10 ng/mL, 7.5 and 12.5 ng/mL samples. All 20 replicates of spiked 7.5 ng/mL and 12.5 ng/mL samples are detected as Negative and Positive, respectively, when compared to 10 ng/mL spiked sample.

In semi-quantitative mode, the spiked samples recover within 80–120% of the nominal values.

C. Dilution Linearity:

The assay demonstrates linearity throughout the calibration range of 0 to 20 ng/mL and R > 0.99. The mean recovery at each level is within 80-120% of expected values.

D. Method Comparison:

{9}------------------------------------------------

The negative agreement in qualitative mode is 100% and semi-quantitative mode is 98.4%. The positive agreement in qualitative mode is 100% and Semi-quantitative mode is 98.3%. The overall correlation agreement in Qualitative mode is 100% and Semi-quantitative mode is 98.4%.

E. Specificity:

Cross-Reactivity

The assay is specific for 6-Acetylmorphine and demonstrates cross-reactivity to heroin. Minimal cross-reactivity is observed with other structurally related and unrelated compounds.

Interference

Results demonstrate that there is no significant interference from the endogenous and exogenous substances in human urine at the tested concentrations, in samples within pH range of 3-11 and in samples with specific gravity within 1.000-1.030.

F. Stability:

Reagent On-Board Stability

Reagent On-Board stability studies for one lot stored on-board clinical analyzer supports the claim of 60 days for qualitative and semi-quantitative modes.

Reconstituted Reagent Stability

Reconstituted Reagent stability studies for one lot stored at 2-8°C supports the claim of 60 days for qualitative and semi-quantitative modes.

Open Vial Stability

Open Vial stability studies for one lot stored at 2-8°C supports the claim of 60 days for qualitative and semi-quantitative modes. This data was presented in the original 510(k) submission K192943.

Real Time Stability for Reagent

Real time stability studies for three lots of reagents stored at 2–8°C have been carried out for up to 26 months. Proposed shelf-life claim is 24 months. This data was presented in the 510(k) submission K192943.

VII. Conclusion

The information supports a determination of substantial equivalence between CEDIA™ Heroin Metabolite (6-AM) Assay and the predicate device CEDIA™ Heroin Metabolite (6-AM) Assay (K192943).

Regulation Number and Section

§ 862.3650 Opiate test system.

(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).