Diazyme's HCY POC Test Kit is intended to be used with the SMART analyzer in a Point-of-Care setting for the in vitro quantitative determination of total L-homocysteine in serum or plasma. The assay can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. For in vitro diagnostic use only.

Device Description

Diazyme HCY POC Test Kit contains reagents intended for use with the SMART analyzer for the quantitative determination of Homocysteine (HCY) in human serum or plasma. Diazyme HCY POC Test is based on a novel enzyme cycling method as published in the Journal of Clinical Chemistry. In this assay, oxidized HCY is first reduced to free HCY which then reacts with a co-substrate, S-adenosylmethionine (SAM) catalyzed by a HCY S-methyltransferase to form methionine (Met) and S-adenosylhomocysteine (SAH). SAH is assessed by coupled enzyme reactions including SAH hydrolase, adenosine (Ado) deaminase and glutamate dehydrogenase, wherein SAH is hydrolyzed into adenosine (Ado) and HCY by SAH hydrolase. The formed HCY that is originated from the co-substrate SAM is cycled into the HCY conversion reaction by HCY S-methyltransferase. This forms a co-substrate conversion product-based enzyme cycling reaction system with signification of detection signals. The formed Ado is immediately hydrolyzed into inosine and ammonia which reacts with glutamate dehydrogenase with concomitant conversion of NADH to NAD+. The concentration of HCY in the sample is indirectly proportional to the amount of NADH converted to NAD+ (ΔA340mm).

The Diazyme HCY POC Test system thus consists of the following:

HCY POC Test Kit. Reagents are provided in prefilled tubes, cuvettes and . cuvette caps. The DRS cuvette and cuvette caps can only work with the SMART analyzer.
HCY POC Test Control Kit. Controls are provided for quality control of the . HCY POC Test.

AI/ML Overview

Here’s an analysis of the acceptance criteria and study data for the Diazyme HCY POC Test, based on the provided document:

Acceptance Criteria and Device Performance for Diazyme HCY POC Test

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance
Precision (Manufacture site)	"These results meet precision criteria." (Implied generally low CV%)	Within CV%:- 7.5 µmol/L HCY: 3.2%- 11.8 µmol/L HCY: 1.8%- 29.0 µmol/L HCY: 2.8%Total CV%:- 7.5 µmol/L HCY: 3.4%- 11.8 µmol/L HCY: 3.5%- 29.0 µmol/L HCY: 3.3%
Precision (POL sites - 1)	"The results indicated good precision..." (Implied generally low CV%)	POL 1 (Sample 1): Within CV% 3.1%, Total CV% 5.2%POL 1 (Sample 2): Within CV% 2.8%, Total CV% 3.7%POL 1 (Sample 3): Within CV% 2.8%, Total CV% 4.1%POL 1 (Sample 4): Within CV% 3.5%, Total CV% 6.0%POL 1 (Sample 5): Within CV% 2.6%, Total CV% 3.2%
Precision (POL sites - 2)	"a CV% of less than 8% was obtained at the three POL sites." for 9 serum samples ranging from 10.26 µmol/L to 42.73 µmol/L.	Site 1: - Sample 1: Total CV 7.0%- Sample 2: Total CV 5.3%- Sample 3: Total CV 6.4%Site 2:- Sample 1: Total CV 6.6%- Sample 2: Total CV% 5.5%- Sample 3: Total CV% 4.4%Site 3:- Sample 1: Total CV% 6.0%- Sample 2: Total CV% 6.8%- Sample 3: Total CV% 5.5%
Linearity/Reportable Range	Implied acceptable linearity and range. Based on R2, often >0.99 for diagnostic assays.	Linear from 3 - 50 µmol/L.Regression equation: Recovered HCY = 0.9749 * Expected HCY + 0.751Correlation coefficient (R2): 0.9992
Traceability	Traceable to a higher-order standard.	HCY POC Test calibration is traceable to the higher order NIST SRM 1955.
Stability	Implied acceptable stability duration.	Real-time data showed stability for at least 10 months at 2-8℃ storage. (Testing is ongoing).
LoB, LoD, LoQ	Distinct, measurable limits.	LoB = 0.06 µmol/LLoD = 0.32 µmol/LLoQ = 3.00 µmol/L
Interference	"produced less than 10% deviation" for common endogenous substances at specified concentrations.	All listed endogenous substances (Ascorbic Acid, Bilirubin, Hemoglobin, Triglyceride, Glutathione, Methionine, Cysteine, Pyruvate, Cystathionine, Hydroxylamine, Carbamezapine, Methotrexate, Phenytoin, 6-azauridine triacetate, S-adenosyl-methionine, Carbamezapine-10, 11-epoxide, Ethosuximide, Primidone, Valporic Acid, Sodium Nitrate) produced less than 10% deviation at the specified concentrations.
Method Comparison (Internal)	Strong correlation and agreement with predicate device (Diazyme HCY Two Reagent Enzymatic Assay on Olympus AU400). Implied R > 0.95.	n: 74Slope: 0.9612Intercept: 0.5246Correlation coefficient (R): 0.9696Range of values: 4.17-49.50 µmol/L
Method Comparison (External)	Strong correlation and agreement with predicate device at POL sites. Implied R2 > 0.95.	All 120 samples combined:Slope: 1.0552Intercept: -0.8860R2: 0.9765Range: 3.88-49.86 µmol/L (across sites)- Site 1: Slope 1.0890, Intercept -0.7438, R2 0.9830- Site 2: Slope 1.0041, Intercept -0.6251, R2 0.9645- Site 3: Slope 1.0600, Intercept -1.1564, R2 0.9819
Matrix Comparison	No significant matrix effect between serum, EDTA plasma, and Li Heparin plasma.	EDTA plasma: Slope = 1.0197, R = 0.9889Li Heparin plasma: Slope = 0.9632, R = 0.99Conclusion: No matrix effect between serum, EDTA plasma and Li Heparin Plasma.

2. Sample Size Used for the Test Set and Data Provenance

Precision (Manufacture site): 40 points per HCY level (3 levels). Data provenance is internal (manufacturer site). Prospective data collection for this internal study.
Precision (POL sites - 1): 20 points for each of 5 samples. Data provenance is external (three Physician Office Laboratories - POLs). Prospective data collection for this external study.
Precision (POL sites - 2): 20 points for each of 3 samples per site, across 3 sites. Data provenance is external (three POLs with multiple users). Prospective data collection for this external study.
Linearity/Assay Reportable Range: Ten levels of linearity set, tested in triplicate. Data provenance is internal (manufacturer site). Prospective data collection.
Interference: 12μM and 29μM HCY serum samples spiked with various concentrations of interferents. Data provenance is internal (manufacturer site). Prospective data collection.
Method Comparison (Internal): 74 individual serum samples. Data provenance is internal (manufacturer site). Likely prospective/retrospective (spiked samples indicate some manipulation).
Method Comparison (External): 120 serum specimens total (40 samples at each of three POL sites). Data provenance is external (three POL sites). Prospective data collection.
Matrix Comparison: 40 sample sets (serum/EDTA plasma/Li Heparin). Data provenance is internal (manufacturer site). Prospective data collection.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of device (a quantitative in-vitro diagnostic assay) does not typically use human experts to establish "ground truth" for the test set in the way an imaging AI algorithm would. Instead, the "ground truth" for the test samples is established by:

Reference Methods: The predicate device itself (Diazyme HCY Two Reagent Enzymatic Assay on Olympus AU400 cleared under K071971) serves as the reference method for comparison studies, implicitly providing the "ground truth" values for patient samples. The predicate device itself would have been validated against a higher standard.
Known Concentrations: For studies like linearity, LoB/LoD/LoQ, and interference, samples with precisely known concentrations of HCY or interfering substances are prepared according to recognized laboratory standards (e.g., CLSI guidelines).
NIST SRM 1955: For calibrator traceability, the device is linked to a National Institute of Standards and Technology (NIST) Standard Reference Material, which represents a highly accurate and reliable "ground truth" for homocysteine concentration.

Therefore, no information on the number or qualifications of experts establishing ground truth in the context of clinical interpretation or annotations is applicable or provided.

4. Adjudication Method for the Test Set

Not applicable. As a quantitative in-vitro diagnostic test, "adjudication" in the sense of resolving conflicting interpretations (like in imaging studies) is not performed. The results are numerical values that are compared against a reference method or known concentrations.

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

Not applicable. This is an in-vitro diagnostic device for quantitative bodily fluid analysis, not an imaging AI or decision-support tool for human interpretation. Therefore, MRMC studies and "human readers improving with AI assistance" are not relevant to this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the studies presented are essentially "standalone" performance evaluations of the device (HCY POC Test Kit + SMART analyzer). The device provides a quantitative result directly, without requiring human interpretation of raw data or human modification of the algorithm's output for its primary function. The users (nurses, office assistants) described in the POL precision studies are operating the device, but their "performance" isn't being measured in terms of their diagnostic accuracy, but rather their ability to correctly perform the test yielding consistent results.

7. The Type of Ground Truth Used

The ground truth used depends on the specific performance characteristic being evaluated:

For Precision, Linearity, LoB/LoD/LoQ: Samples with precisely known concentrations of HCY, prepared in the laboratory or from certified reference materials (like NIST SRM 1955 for traceability).
For Method Comparison: The values obtained from the predicate device (Diazyme HCY Two Reagent Enzymatic Assay on an Olympus AU400, K071971) were used as the reference "ground truth" for comparison.
For Interference: Samples with known HCY concentrations spiked with known concentrations of suspected interfering substances.

8. The Sample Size for the Training Set

This document describes a premarket approval (510(k)) submission for an in-vitro diagnostic assay kit. Such submissions typically detail validation studies for the finished product, not the development or training of an algorithm in the machine learning sense. The "SMART analyzer" uses an RFID card with a preprogrammed calibration curve, which is derived from testing 5 levels of calibrators with the reagents.

The training set for the calibration curve programming on the RFID card involves testing "5 levels of calibrators used in the predicate device (K071971)" with the Diazyme HCY POC Test reagents on SMART analyzers. The exact number of replicates or runs during this programming phase is not specified beyond "mean of absorbance change."

9. How the Ground Truth for the Training Set Was Established

The "ground truth" for establishing the calibration curve (which is the "training set" in a functional sense for this IVD) is established by using:

Reference Diazyme Homocysteine calibrator values (K071971): These calibrators themselves would have assigned values traceable to higher-order standards.
NIST SRM 1955: The overall calibration is tied to this higher-order standard.

The process involves testing these known calibrators on the SMART analyzer to obtain absorbance changes, and then programming a curve that correlates these absorbance changes to the known HCY concentrations, which constitutes the "ground truth" for the device's measurement function.

Summary

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Premarket approval Homocysteine PC

510(k) SUMMARY AND SUBSTANTIAL EQUIVALENCE COMPARISON

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

Submitter's name:	Diazyme Laboratories	JUL 31 2012
Submitter's address:	12889 Gregg CourtPoway, CA 92064USA
Name of Contact Person:	Dr. Abhijit DattaDiazyme Laboratories12889 Gregg CourtPoway, CA 92064Phone: 858-455-4762Fax: 858-455-2120
Name of the Device	HCY POC Test
Trade Name	HCY POC Test
Common Usual Name	SMART Homocysteine Assay
Device Classification Name	HCY POC Assay
Product Code	LPS; Test, Homocysteine
Panel	Clinical Chemistry (75)
Submission Type	510K
Regulation Number	21CFR 862.1377
Device Class	Class II (Assay)
Predicate Device	Diazyme Homocysteine AssayK071971
Establishment Registration	2032900

Executive Summary

Detailed performance characteristics and comparison analysis are given in this filing and demonstrate substantial equivalence to predicate device that is currently being marketed. The performance characteristics of the Diazyme HCY POC Test Kit are substantially similar to that of the

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approved predicate device DIAZYME HOMOCYSTEINE 2 REAGENT ENZYMATIC ASSAY KIT (K071971). Performance data and risk analysis indicates that differences should not affect the safety and effectiveness of the HCY POC Test and offers POL users an in vitro diagnostic device system to measure HCY in human serum/plasma samples.

Description of the Device:

Diazyme Homocysteine POC Controls were cleared in previous FDA filing K042448.

SMART Analyzer (K092911) is a compact cuvette based spectrophotometer (10 inches x 5.5 inches x 5.5 inches) machine for point-of-care testing designed to analyze readings from single use reagent cuvette. The instrument only uses the Diazyme Reagent System (DRS) cuvette and caps and performs assay with a preprogrammed Radio Frequency ID (RFID) card. The DRS cuvette is supplied prefilled with Reagent 1 (R1) and the DRS cap is supplied prefilled with Reagent 2 (R2). The DRS cuvette and caps are kept separate until use. Users are instructed (see proposed labeling) to add 20ul of sample to the DRS cuvette prefilled with R1 containing proper amount of detergent for whole blood lysis. Users are then instructed to snap in place DRS cap and insert into analyzer. The instrument warms the cuvette to 37℃ and after a predefined period adds the reagent R2 found in the DRS cap. The reagents and samples are mixed magnetically and absorbance readings are taken at 700nm. The lot specific RFID card contains reagent addition time, mixing time, reading time and calibration curve.

The Diazyme HCY POC Test system thus consists of the following:

HCY POC Test Kit. Reagents are provided in prefilled tubes, cuvettes and . cuvette caps. The DRS cuvette and cuvette caps can only work with the SMART analyzer.
HCY POC Test Control Kit. Controls are provided for quality control of the . HCY POC Test.

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Indication (s) for use

			Table 1 Summary of Assay Kit Components
--	--	--	-----------------------------------------

Candidate device
Kit can ONLY be used with SMART Analyzers
Reagent 1
20 DRS cuvettes (prefilled)
• NADH and substrates, same as the predicate
Reagent 2
20 DRS caps (prefilled)
• Enzymes and stabilizers, same as the predicate
Calibrator
1 x preprogrammed lot specific RFID card in each kit
Control Set
Control (serum based, read to use), same as the predicate

Performance Characteristics:

Precision/Reproducibility

Precision study at manufacture site

The precision of the Diazyme HCY POC Assay was evaluated according to Clinical and Laboratory Standards Institute (CLSI) EP5-A guideline with some modifications. In the study, three serum controls containing 7.3, 11.87, and 29.32umol/L HCY were tested in duplicate, two runs per day, over ten working days. The first five days used Lot 1, HT00209, and subsequent five days used Lot 2, HT00309. This was performed on three different SMART Analyzers. The results indicated good precision and are summarized in the following table:

	7.3µmol/LHCY	11.87µmol/LHCY	29.32µmol/LHCY
No. of Points	40	40	40
Mean (µM)	7.5	11.8	29.0
Within CV%	3.2%	1.8%	2.8%
Total CV%	3.4%	3.5%	3.3%

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Conclusion: Within precisions for three levels of HCY serum samples are 3.2% for 7.5μmol/L HCY, 1.8% for 11.87 µmol/L HCY, and 2.8% for 29.0 mol/L HCY. Total precisions (CV) for three levels of HCY serum samples are 3.4% for 7.5umol/L HCY, 3.5% for 11.87 umol/L HCY, and 3.3% for 29.0umol/L HCY. These results meet precision criteria.

Precision studies at three POL sites

The precision was also evaluated in three physician office laboratories (POL) by intended users such as nurses and office assistances to test systemic and random error on two Diazyme HCY SMART analyzers. Two serum specimens were used at each POL site, the two serum specimens were run in 4 replicates per day for 5 days. The results indicated good precision and are summarized in the following table:

	Sample 1Site 1	Sample 2Site 2	Sample 3Site 3	Sample 4Site 1 and 2	Sample 5Site 3
No. of Points	20	20	20	40	20
Mean ( $ \mu $ mol/L)	4.89	10.68	13.71	29.83	42.92
Within CV%	3.1%	2.8%	2.8%	3.5%	2.6%
Total CV%	5.2%	3.7%	4.1%	6.0%	3.2%

The results are summarized in the following tables:

(3) Additional precision study was evaluated at three physician office laboratories (POL) with multiple users at each site. A total of 9 serum samples containing HCY levels ranging from low to high were used for the precision study. At each site, 3 serum samples were tested by three different people. Each sample was run 4 times for 5 days.

The results are summarized in the following tables: Site 1·

Site 1.	Sample 1	Sample 2	Sample 3
No. of Points	20	20	20
Mean (µmol/L)	11.05	25.82	42.73
Within run CV	6.7%	6.2%	5.60%
Total CV	7.0%	5.3%	6.4%

Site 2:

	Sample 1	Sample 2	Sample 3
No. of Points	20	20	20
Mean (µmol/L)	10.26	25.18	41.99
Within run CV%	6.9%	5.2%	3.8%
Total CV% -	6.6%	5.5%	4.4%

Site 3:

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Mean (µmol/L)	11.63	26.34	31.63
SD (µmol/L)	0.4941	1.9883	1.8298
Within run CV%	4.2%	7.5%	5.8%
Total CV%	6.0%	6.8%	5.5%

Conclusion: For the 9 serum samples containing HCY from 10.26 µmol/L to 42.73 µmol/L, a CV% of less than 8% was obtained at the three POL sites.

Linearity/assay reportable range:

Ten levels of linearity set were prepared by diluting a serum control containing 50μmol/L HCY with saline according to Clinical and Laboratory Standards Institute (CLSI) EP6-A. The samples prepared were tested using the Diazyme's HCY POC Assay in triplicate. After linear regression, an equation of Recovered HCY = 0.9749 * Expected HCY + 0.751 and correlation coefficient R2 of 0.9992 were obtained.

The linearity of Diazyme HCY SMART Assay is linear 3 - 50 µmol/L.

Traceability, Stability, Expected values (controls, calibrators, or methods):

Calibrator

HCY POC Test calibration is traceable to the higher order NIST SRM 1955.

Calibration Radio Frequency Identification Card (RFID card)

HCY POC Test utilizes a RFID card that is preprogrammed with a reagent lot specificcalibration curve and is supplied in each kit. When RFID card is inserted into SMART analyzer slot (assay procedure step), the lot specific calibration curve is automatically utilized for assay test. RFID cards are programmed at the manufacturer site and are subject to the same quality control checks as the reagents and controls.

Lot specific calibrator values to be generated for RFID card calibration curve programming are traced to reference Diazyme Homocysteine calibrator values (K071971) and are value assigned as follows:

· To construct Diazyme HCY SMART Assay RFID card calibration curve, 5 levels of calibrators used in the predicate device (K071971) are tested with the Diazyme HCY POC Test reagents on SMART analyzers to obtain the rate of absorbance change. The calibrator value and the mean of absorbance change are programmed into cards by using a card writer.
· After creation of the RFID card it is used for in process and final QC testing (Step 3: Final calibration values). Tests include NIST SRM 1955, Diazyme Homocysteine Controls, and serum samples.

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Stability

Two lots of the Diazyme HCY POC Assay reagents were used for this study. The reagents from each lot were kept 2-8°C refrigerator. In the study, two levels of serum control samples containing 7.31 uM. and 29.53 uM homocysteine were tested. At indicated time, the Diazyme HCY POC Assay reagents were removed from storage and tested. The real time data so far showed that the HCY POC Test is stable for at least 10 months at 2-8℃ storage. The real time stability testing is on-going.

LoB, LoD,LoQ

The LoB, LoD, and LoQ of the Diazyme HCY POC Test Kit were determined according to CLSI EP17-

A. LoB = 0.06 µmol/L LoD = 0.32 umol/L LoQ = 3.00 umol/L.

Interference

Common endogenous substance interference

The level of interference from the substances normally present in the serum was determined by using Diazyme Homocysteine SMART Enzymatic Assay to test 12μM and 29μM HCY serum samples spiked with various concentrations of substances following Clinical and Laboratory Standards Institute EP7-A "Interference Testing in Clinical Chemistry": dose-response guidelines.

Interference	Concentration
Ascorbic Acid	10mmol/L
Unconjugated Bilirubin	40mg/dL
Conjugated Bilirubin	40mg/dL
Hemoglobin	500mg/dL
Triglyceride	1000mg/dL
Glutathione	500 µM
Methionine	20 µM
Cysteine	1000 μM
Pyruvate	500 µM
Cystathionine	100 µM
Hydroxylamine	1000 μM
Carbamezapine	130 µM
Methotrexate	2.0 mM
Phenytoin	200 µM
6-azauridine triacetate	1000 µM
S-adenosyl-methionine	20 µM
Carbamezapine-10, 11-epoxide	60 µM
Ethosuximide	1800 µM

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Primidone	200 $ μ $ M
Valporic Acid	3.5 mM
Sodium Nitrate	500 $ μ $ M

Conclusion: The following substances normally present in serum produced less than 10% deviation when tested at levels equal to the concentrations listed below

Comparison Studies

Method comparison with predicate device

To demonstrate accuracy, the Diazyme HCY Enzymatic SMART Assay was tested with individual serum samples and run in parallel with the Diazyme HCY Two Reagent Enzymatic Assay on the Olympus AU400.

Serum samples were used for the comparison experiment. To ensure the concentrations of HCY distributed across the reportable dynamic range, additional HCY samples used for the study were spiked with stock solution of HCY to targeted concentrations.

The regression results are summarized in the following table:

	application
n	74
Slope .	0.9612
Intercept	0.5246
Correlation coefficient	0.9696
Range of values	4.17-49.50 μmol/L

The method comparison study was performed externally at the three POL sites. One Hundred and Twenty (120) serum specimens are used in total (40 samples at each site). The Diazyme HCY POC reagents were used to test individual serum samples with comparison to Diazyme Enzymatic HCY Assay on Olympus AU400 (K061971).

SMART HCY	Site 1	Site 2	Site 3	All combined
n	40	40	40	120
Slope	1.0890	1.0041	1.0600	1.0552
Intercept	-0.7438	-0.6251	-1.1564	-0.8860
R2	0.9830	0.9645	0.9819	0.9765

The regression results are summarized in the following table

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Matrix comparison

To evaluate the anticoagulant effects of EDTA plasma and Li Heparin Plasma of the HCY levels, 40 sample sets serum/EDTA plasma/Li Heparin were tested on SMART analyzer using HCY POC Test Kits.

Results: Slope = 1.0197 and 0.9632 for EDTA plasma and Li Heparin respectively, and R = 0.9889 and 0.99 for EDTA plasma and Li Heparin respectively.

Conclusion: There is no matrix effect between serum, EDTA plasma and Li Heparin Plasma.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/8/Picture/1 description: The image is a seal for the Department of Health & Human Services USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

10903 New Hampshire Avenue Silver Spring, MD 20993

Diazyme Laboratories c/o Abhijit Datta 12889 Gregg Court Poway, CA 92064

JUL 3 1 2012

Re: K121053

Trade Name: Diazyme Homocysteine POC Test Regulation Number: 21 CFR §862.1377 Regulation Name: Urinary Homocysteine (non-quantitative) test system Regulatory Class: Class II Product Codes: LPS Dated: July 11, 2012 Received: July 13, 2012

Dear Dr. Datta:

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical

Devices/Safety/ReportaProblem/default.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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm

Sincerely yours,

Countney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device

Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

K121653

510(k) Number (If Known):

Device Name: Diazyme Homocysteine POC Test Kit

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/Or

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

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Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)

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Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

121053 510(k)

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Regulation Number and Section

§ 862.1377 Urinary homocystine (nonquantitative) test system.

(a)
Identification. A urinary homocystine (nonquantitative) test system is a device intended to identify homocystine (an analogue of the amino acid cystine) in urine. The identification of urinary homocystine is used in the diagnosis and treatment of homocystinuria (homosystine in urine), a heritable metabolic disorder which may cause mental retardation.(b)
Classification. Class II.