The Fastep S10 hCG Serum/Urine Combo Test is a rapid visual immunoassay for the qualitative, presumptive detection of human chorionic gonadotropin in human urine or serum specimens. This kit is intended for use as an aid in early detection of pregnancy. This product is only intended for prescription use in clinical laboratories and is not intended for point-of-care use settings.

Device Description

Fastep S10 hCG Serum/Urine Combo Test measures the presence of the hormone Human Chorionic Gonadotrophin (HCG) in human urine or serum for the early detection of pregnancy. During pregnancy, HCG is produced by the placenta shortly after the embryo attaches to the uterine lining. The test devices are in two different formats: Strip, Cassette.

AI/ML Overview

The Fastep S10 hCG Serum/Urine Combo Test is a rapid visual immunoassay for the qualitative, presumptive detection of human chorionic gonadotropin in human urine or serum specimens, intended as an aid in early detection of pregnancy. It is for prescription use in clinical laboratories and not for point-of-care use.

1. Table of Acceptance Criteria and Reported Device Performance

Test Type	Acceptance Criteria (Implicit)	Reported Device Performance
Analytical Performance
Precision/Reproducibility/Cut-Off Value (Serum Strip)	High agreement at 0 mIU/mL and at/above cut-off (10 mIU/mL), with some variability expected near the cut-off.	0 mIU/mL: 100% agreement (90 negative results across 3 lots).8 mIU/mL (below cut-off): 91% agreement (25 "negative", 5 "positive").9 mIU/mL (below cut-off): 71% agreement (16 "negative", 14 "positive").10 mIU/mL (cut-off): 97% agreement (3 "negative", 87 "positive").12 mIU/mL - 150 mIU/mL (above cut-off): 100% agreement (all positive).
Precision/Reproducibility/Cut-Off Value (Serum Cassette)	High agreement at 0 mIU/mL and at/above cut-off (10 mIU/mL), with some variability expected near the cut-off.	0 mIU/mL: 100% agreement (90 negative results across 3 lots).8 mIU/mL (below cut-off): 90% agreement (27 "negative", 3 "positive").9 mIU/mL (below cut-off): 74% agreement (20 "negative", 10 "positive").10 mIU/mL (cut-off): 96% agreement (4 "negative", 86 "positive").12 mIU/mL - 150 mIU/mL (above cut-off): 100% agreement (all positive).
Precision/Reproducibility/Cut-Off Value (Urine Strip)	High agreement at 0 mIU/mL and at/above cut-off (20 mIU/mL), with some variability expected near the cut-off.	0 mIU/mL: 100% agreement (90 negative results across 3 lots).16 mIU/mL (below cut-off): 88% agreement (26 "negative", 4 "positive").18 mIU/mL (below cut-off): 66% agreement (10 "negative", 20 "positive").20 mIU/mL (cut-off): 96% agreement (4 "negative", 86 "positive").22 mIU/mL - 250 mIU/mL (above cut-off): 100% agreement (all positive).
Precision/Reproducibility/Cut-Off Value (Urine Cassette)	High agreement at 0 mIU/mL and at/above cut-off (20 mIU/mL), with some variability expected near the cut-off.	0 mIU/mL: 100% agreement (90 negative results across 3 lots).16 mIU/mL (below cut-off): 80% agreement (18 "negative", 12 "positive").18 mIU/mL (below cut-off): 57% agreement (13 "negative", 17 "positive").20 mIU/mL (cut-off): 98% agreement (2 "negative", 88 "positive").22 mIU/mL - 100 mIU/mL (above cut-off): 100% agreement (all positive).
Stability	Stable at specified temperature ranges for the stated duration.	Stable at 4-30°C for 24 months based on accelerated stability study at 50°C and real-time stability determination at 4°C and 30°C.
Specificity / Cross Reactivity	No hook effect at high hCG concentrations. No significant interference from hCG B-core fragment, LH, FSH, and TSH at specified concentrations.	High Dose Effect: No hook effect observed up to 2,000,000 mIU/mL hCG.Effects of hCG B-core fragment: Interference observed at 500 pmol/L and above for hCG-free samples; no interference for samples spiked with 10mIU/mL hCG (serum) or 20mIU/mL hCG (urine).Effects of glycoprotein LH, FSH, and TSH: No interference observed at tested concentrations (LH 300mIU/mL, FSH 1000mIU/mL, TSH 1000µIU/mL) for negative and positive hCG samples (0, 10, 20 mIU/mL).
Interference	No interference from common exogenous compounds at stated concentrations.	All listed compounds (Acetaminophen, Acetoacetic Acid, Ascorbic Acid, B-hydroxybutyrate, Caffeine, Ephedrine, Gentisic Acid, Phenylpropanolamine, Salicylic Acid, Phenothiazine, EDTA, Acetylsalicylic Acid, Benzoylecgonine, Cannabinol, Codeine, Ethanol, Methanol, Albumin, Glucose, Bilirubin, Atropine, Estriol-17-beta, Hemoglobin, Pregnanediol, Thiophene, Ampicillin, Tetracycline, Ketone) showed no interference in both hCG-free and hCG-positive samples at the stated concentrations, for both 3-minute and 10-minute read times.
Effect of Urine Specific Gravity and pH	No interference from varying urine specific gravity and pH.	pH: No interference observed for urine samples with pH from 4 to 9 in both negative and positive (20 mIU/mL hCG) samples.Specific Gravity: No interference observed for urine samples with specific gravity from 1.000 to 1.035 in both negative (5 mIU/mL hCG) and positive (20 mIU/mL hCG) samples.
Comparison Studies	High agreement (e.g., >95% for positive, 100% for negative) with a legally marketed predicate device.	"The study result shows that over 95% agreements for positive samples, and 100% agreement for negative samples." (This general statement applies to all four comparison tables: Urine Strip, Urine Cassette, Serum Strip, Serum Cassette, though the tables themselves have corrupted data).

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

Precision/Reproducibility/Cut-Off Value Studies:
- For serum (strip and cassette formats): 15 hCG concentrations were tested. For each concentration, 10 replicates were measured for 3 different lots, by 3 different operators, in 2 runs per day for 5 days. This sums to 10 replicates * 3 lots * 3 operators * 2 runs * 5 days = 900 tests per hCG concentration. The results tables show 30 results (10 replicates x 3 operators) per lot, and thus 90 results per hCG concentration across the 3 lots.
- For urine (strip and cassette formats): Similar to serum, 15 hCG concentrations were tested. For each concentration, 10 replicates were measured for 3 different lots, by 3 different operators, in 2 runs per day for 5 days. This sums to 10 replicates * 3 lots * 3 operators * 2 runs * 5 days = 900 tests per hCG concentration. The results tables show 30 results (10 replicates x 3 operators) per lot, and thus 90 results per hCG concentration across the 3 lots.
- Data Provenance: Not explicitly stated (e.g., country of origin), but implied to be clinical laboratory settings given the intended use. These were spiked samples, not naturally occurring patient samples.
High Dose Effect Study: Spiked negative urine/serum samples with 7 different high hCG concentrations. Tested by 3 different lots and 3 different operators. The number of replicates per concentration is not specified but the table shows a consistent positive result.
Effects of hCG B-core fragment Study: Serum samples with 0mIU/mL and 10mIU/mL hCG were spiked with 14 different concentrations of B-core fragment. Urine samples with 0mIU/mL and 20mIU/mL hCG were spiked with the same B-core fragment concentrations. Tested by 3 different lots and 3 different operators. Number of replicates not specified.
Effects of glycoprotein LH, FSH and TSH Study: Negative and positive samples (0 and 20 mIU/mL hCG for urine, 0 and 10 mIU/mL hCG for serum) were spiked with various concentrations of LH, FSH, and TSH. Tested by 3 different lots and 3 operators. Number of replicates not specified.
Interference Study: Each of 19 interferents was spiked into hCG-free and hCG-positive (10mIU/mL for serum, 20mIU/mL for urine) samples. Each spiked sample was tested using 3 different lots of the kit. Number of replicates not specified but results for all 3 lots are shown.
Effect of Urine Specific Gravity and pH Study: Urine samples (negative and positive at 20 mIU/mL hCG) tested at 6 pH values (4-9). Urine samples (negative and positive at 5 and 20 mIU/mL hCG) tested at 5 specific gravity values (1.000-1.035). Tested using 3 different lots by 3 different operators. Number of replicates not specified.
Comparison Studies:
- 100 urine samples and 100 serum samples were collected from 100 women.
- Data Provenance: Not explicitly stated (e.g., country of origin). The samples were "collected from 100 women (about half of them were pregnant, early stage at less than 5 weeks)." This suggests prospective collection for the study.

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

Precision/Reproducibility/Cut-Off Value Studies: The "ground truth" (i.e., expected positive/negative based on hCG concentration) was established by using commercially available hCG traceable to the 4th WHO international Standard. These were spiked samples, so the hCG concentration was known.
Comparison Studies: Ground truth for the 100 urine and 100 serum samples was established by the "results from predicate devices (QVUE)". It's not explicitly stated that experts established the ground truth for these samples; rather, the predicate device served as the reference.
Other Studies (Specificity, Interference, pH/Specific Gravity): Ground truth was based on the known spiked concentrations of hCG or interferents.

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

Precision/Reproducibility/Cut-Off Value Studies, High Dose Effect, hCG B-core fragment, Glycoprotein hormones, Interference, pH/Specific Gravity: Data was collected by 3 different operators for each lot. The tables show the results from each individual lot, and then an "Overall Agreement" is calculated based on the total number of negative/positive results across the 3 lots. There is no explicit mention of an adjudication process (e.g., if operators disagreed).
Comparison Studies: "Samples were tested by three different health professionals with the proposed and the predicate devices." It is not stated how discrepancies between the health professionals were resolved or if their readings were adjudicated. The summary tables combine results, implying an agreement or average.

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:

No, this is not an MRMC comparative effectiveness study involving AI. It is a comparison study between a new device and a predicate device, using human readers for both. Therefore, no effect size of human readers improving with or without AI assistance is reported.

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

No, this device is a rapid visual immunoassay (test strip/cassette) intended to be interpreted visually by human users ("health professionals"). There is no algorithm or AI component, and thus no standalone algorithm-only performance was conducted or is applicable.

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

For analytical performance metrics (precision, specificity, interference, pH/specific gravity), the ground truth was based on known spiked concentrations of hCG, interferents, or controlled pH/specific gravity levels. This is essentially a controlled laboratory standard.
For the comparison studies, the ground truth was established by the predicate device (QuickVue One-Step hCG Combo test).

8. The sample size for the training set:

This device is not an AI/ML algorithm, so there is no "training set" in the conventional machine learning sense. The performance data presented are for verification and validation of the device's analytical and clinical performance.

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

As there is no AI/ML component, there is no "training set" or ground truth for a training set.

Summary

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K132834

JAN - 9 2014

510(k) SUMMARY

December 20, 2013 1. Date: 2. Submitter: POLYMED THERAPEUTICS, INC. 3040 Post Oak Blvd Ste 1110 Houston, TX 77056 Contact person: Joe Shia 3: LSI International Inc. 504 East Diamond Ave., Suite F Gaithersburg, MD 20878 Telephone: 240-505-7880 Fax: 301-916-6213 Email:shiajl@yahoo.com
1. Device Name:

Fastep S10 hCG Serum/Urine Combo Test

Classification: Class II

ProductCode	CFR #	Panel
JHI	862.1155, Human chorionicgonadotropin (HCG) test system	Clinical Chemistry

1. Predicate Devices:
  K020801, QuickVue One-Step hCG Combo test

Quidel Corporation

1. Intended Use
  The Fastep S10 hCG Serum/Urine Combo Test is a rapid visual immunoassay for the qualitative, presumptive detection of human chorionic gonadotropin in human urine or serum specimens. This kit is intended for use as an aid in early detection of pregnancy.

This product is only intended for prescription use in clinical laboratories and is not intended for point-of-care use settings.

1. Device Description
  Fastep S10 hCG Serum/Urine Combo Test measures the presence of the hormone Human Chorionic Gonadotrophin (HCG) in human urine or serum for the early detection of pregnancy. During pregnancy, HCG is produced by the placenta shortly after the embryo attaches to the uterine lining. The test devices are in two different formats: Strip, Cassette.
1. Substantial Equivalence Information
  A summary comparison of features of the Fastep S10 hCG Serum/Urine Combo Test and the predicate device is provided in the following table.

Item	Device	Predicate
Intended Use	Rapid qualitative detection of hCGto aid in the early detection ofpregnancy. For prescription use inclinical laboratories, not for POC	Same except that thepredicate can be used forPOC use settings.

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		use.
Specimen	Urine or serum	Same
Principle	Lateral flow SandwichImmunochromatographic Assay	Same
Detection reagent	Colloidal gold	Same
Read time	Serum: 5 minutes Urine: 3minutes	Same
Usage	For prescription use	Same
Cut-Off Values	10 mIU/mL for serum and 20mIU/mL for urine	Same
Configurations	Strip and cassette	Same
Storage	4 - 30°C	15 - 30°C
Reading ControlWindow	1 window for result reading andcontrol reading	2 windows: Small ControlWindow and Large ReadResult Window
Read ResultWindow	No preprinted line on membrane	Pre-printed horizontalblue line on membrane
Positive result	2 colored red/pinkish horizontallines in control and test regions	Pink and blue plus signin large Window, alongwith a blue line in smallWindow
Negative result	1 colored line in control region only	Blue horizontal line inLarge Window, alongwith a blue line in smallWindow

9. Test Principle

It is a lateral flow chromatographic immunoassay. When the absorbent end is immersed into a sample, the sample is absorbed into the device by capillary action and mixes with the antibody-dye conjugate (mouse anti-beta HCG monoclonal antibody), flowing across the pre-coated (Goat anti HCG polyclonal antibody) membrane. At analyte concentration above the target cut off, it produces a colored test line that indicates a positive result. When analyte concentration is below the cutoff, no colored band shows in the test region, indicating a , negative result. No line in the "C" region indicates that the test is invalid.

10. Performance Characteristics

1. Analytical Performance
- a. Precision/Reproducibility/Cut-Off Value

Negative serum specimens were spiked with varying hCG (commercially available and traceable to the 4th WHO international Standard) concentrations. The spiked samples were measured in 10 replicates using 3 different lots for each format. Tests were performed by

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three different operators for each lot in 2 runs per day for 5 days. Results are shown in the following tables.

	Lot 1HCG1203004		Lot 2HCG1204001		Lot 3HCG1204023		OverallAgreement
hCGConcentration(mIU/mL)	# ofnegative	# ofpositive	# ofnegative	# ofpositive	# ofnegative	# ofpositive
0	30	0	30	0	30	0	100%
2	30	0	30	0	30	0	100%
4	30	0	30	0	30	0	100%
6	30	0	30	0	30	0	100%
8	28	2	27	3	27	3	91%
9	23	7	20	10	21	9	71%
10	1	29	2	28	0	30	97%
12	0	30	0	30	0	30	100%
14	0	30	0	30	0	30	100%
16	0	30	0	30	0	30	100%
18	0	30	0	30	0	30	100%
20	0	30	0	30	0	30	100%
50	0	30	0	30	0	30	100%
100	0	30	0	30	0	30	100%
150	0	30	0	30	0	30	100%
Serum Cassette format
	Lot 1HCG1212025		Lot 2HCG1305011		Lot 3HCG1306024		OverallAgreement
hCGConcentration(mIU/mL)	# ofnegative	# ofpositive	# ofnegative	# ofpositive	# ofnegative	# ofpositive
0	30	0	30	0	30	0	100%
2	30	0	30	0	30	0	100%
4	30	0	30	0	30	0	100%
6	30	0	30	0	30	0	100%
8	27	3	28	2	26	4	90%
9	24	6	21	9	22	8	74%
10	1	29	1	29	2	28	96%
12	0	30	0	30	0	30	100%
14	0	30	0	30	0	30	100%
16	0	30	0	30	0	30	100%
18	0	30	0	30	0	30	100%
20	0	30	0	30	0	30	100%
50	0	30	0	30	0	30	100%
100	0	30	0	30	0	30	100%
150	0	30	0	30	0	30	100%
hCG	Lot 1HCG1203004		Lot 2HCG1204001		Lot 3HCG1204023		OverallAgreement
Concentration(mIU/mL)	# ofnegative	# ofpositive	# ofnegative	# ofpositive	# ofnegative	# ofpositive
0	30	0	30	0	30	0	100%
5	30	0	30	0	30	0	100%
10	30	0	30	0	30	0	100%
12	30	0	30	0	30	0	100%
14	30	0	30	0	30	0	100%
16	25	5	28	2	26	4	88%
18	21	9	19	11	19	11	66%
20	1	29	2	28	1	29	96%
22	0	30	0	30	0	30	100%
25	0	30	0	30	0	30	100%
30	0	30	0	30	0	30	100%
35	0	30	0	30	0	30	100%
50	0	30	0	30	0	30	100%
75	0	30	0	30	0	30	100%
100	0	30	0	30	0	30	100%
250	0	30	0	30	0	30	100%

Serum Strip format

Negative urine specimens were spiked with varying hCG (commercially available and traceable to the 4th WHO international Standard) concentrations. The spiked samples were

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measured in 10 replicates using 3 different lots for each format. Tests were performed by three different operators for each lot in 2 runs per day for 5 days. Results are shown in the following tables.

Urine Strip format

Urine Cassette format

hCG	Lot 1HCG1212025		Lot 2HCG1305011		Lot 3HCG1306024		Overall
Concentration(mIU/mL)	# of	# of	# of	# of	# of	# of	Agreement
	negative	positive	negative	positive	negative	positive
0	30	0	30	0	30	0	100%
5	30	0	30	0	30	0	100%
10	30	0	30	0	30	0	100%
12	30	0	30	0	30	0	100%
14	30	0	30	0	30	0	100%
16	24	6	26	4	22	8	80%
18	19	11	17	13	15	15	57%
20	1	29	0	30	1	29	98%
22	0	30	0	30	0	30	100%
25	0	30	0	30	0	30	100%
30	0	30	0	30	0	30	100%
35	0	30	0	30	0	30	100%
50	0	30	0	30	0	30	100%
75	0	30	0	30	0	30	100%
100	0	30	0	30	0	30	100%

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-------------------------------------------------------------------	-		And Children Children Charles Comments of Children

Cut-off values of 10 mIU/mL for serum and 20 mIU/mL for urine are established.

b. Stability

Stable at 4-30°C for 24 months based on the accelerated stability study at 50°C and real time stability determination at both 4°C and 30°C.

c. Specificity / Cross Reactivity

High Dose Effect

Negative urine (serum) samples were spiked with varying high hCG concentrations. The spiked samples were tested by 3 different lots and 3 different operators. No hook effect Typical results are shown in the following table. was observed at these concentrations.

hCG Concentration	Operator	Operator	Operator
(mIU/mL)	A	B	C
62500	+	+	+
125000	+	+	+
250000	+	+	+
500000	+	+	+
1000000	+	+	+
2000000	+	+	+

Effects of hCG B-core fragment

Serum samples with 0mlU/mL hCG and 10mIU/mL hCG were spiked with varying concentrations of B-core fragment hCG. These samples were tested by 3 different lots and 3 different operators. No difference was observed for different lots and different operators. Interference was observed at concentrations of 500 pmol/L and above for hCG free serum samples, and no interference was observed for serum samples spiked with 10mIUmL hCG. The same results were observed for urine samples with 0mIU/mL hCG and 20mIU/mL hCG.

β-core fragment	Sample with	Serum Sample with	Urine Sample with
hCG (pmol/L)	0mIU/mL hCG	10mIU/mL hCG	20mIU/mL hCG
0	-	+	+
10	-	+	+
20	-	+	+
50	-	+	+
100	-	+	+
200	-	+	+
500	+	+	+
1000	+	+	+
2000	+	+	+
5000	+	+	+
10000	+	+	+
20000	+	+	+
65000	+	+	+
100000	+	+	+
500000	+	+	+
1X10e6	+	+	+

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2X10e6
--------

Effects of glycoprotein LH, FSH and TSH

Negative and positive samples (0 and 20 mIU/mL hCG for urine, and 0 and 10 mIU/mL hCG for serum) were spiked with various concentrations of other glycoprotein hormones such as LH, FSH, and TSH. Samples were tested using three different lots by three operators. Typical results are shown in the following table.

Negative Sample	Operator	Operator	Operator
Spiked with		13
LH (300mlU/mL)
FSH (1000mIU/mL)
TSH (1000μIU/mL)
Positive SampleSpiked with	OperatorA	OperatorB	OperatorC
LH (300mlU/mL)	+	+	+
FSH (1000mlU/mL)	+	+	+
TSH (1000µIU/mL)	+	+	+

d. Interference

To evaluate potential interference from certain exogenous compounds, each interferent was made at 100X concentrate bulk and spiked in both hCG free and hCG positive (10mlU/mL for serum, 20mIU/mL for urine) samples. Each spiked urine sample was mixed for 5 minutes to ensure a homogeneous solution before testing. Each sample was tested using 3 different lots of the testing kit. Results are shown in the following table.

	3 minutes for urine (5 minutes for serum)					10 minutes
Interferents	0mIU/mL hCG		Positive bCG			0ml U/mL hCG			Positive hCG
	Lot}	Lot2	Lot3	Lot l	Lot2	Lot3	Lot l	Lot2	Lot3	Lot l	Lot2	Lot3
Acetaminophen (20mg/dL)	ﻠ	l	f	+	+	+	-	-	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	+	+	+
Acetoacetic Acid (2000mg/dL)	-	-	l	+	+	+	-	-	l	+	+	+
Asorbic Acid (20mg/dL)	--	-	-	+	+	+	-	-	-	+	+	+
B-hydroxybutyrate (2000mg/dL)	-	l	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	+	+	+	-	-	-	+	+	+
Caffeine (20mg/dL)	-	-	-	+	+	-+-	l	-	-	+	+	+
Ephedrine (20mg/dL)	--	--	l	+	-+-	+	-	-	--	+	+	+
Gentisic Acid (20mg/dL)	. I	--	-	十	+	+	-	-	-	+	+	+
Pheny propanolamine(20mg/dL)	--	l	-	+	+	、十	-	-	-	+	+	+
Salicylic Acid (20mg/dL)	-	-	l	+	-4-	+	l	---	t	+	+	十
Phenothiazine (20mg/dL)	-	--	--	+	-+-	+	-	-	-	+	+	+
EDTA (80mg/dL)	-	-	l	+	+	+	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	-	ﺴﻌ	-+-	+	十
Acetylsalicylic Acid (20mg/dL)	-	-	-	十	+	+	---	l	-	---	+	+
Benzoylecgonine (10mg/dL)	-	-	-	+	+	+	-	l	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	十	十	+
Cannabinol (10mg/dL)	l	l	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	+	+	+	--	-	-	十一	+	+
Codeine (6ug/dL)	-	l	-	+	+	+	-	l	-	---	→	十
Ethanol (1.0%)	--	l	l	-1-	-+-	+	-	l	-	十	+	+
Methanol (10%)	-	--	-	+	+	+	l	l	l	-+-	+	+
Albumin (2000mg/dL)	-	l	-	+	-+-	+	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	l	-	+	+	---

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Glucose (2000mg/dL)				t	+			+
Bilirubin (2mg/dL)	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	P	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	---	----			-1-	--	+
Atropine (20mg/dL)			十一	+	+			+	+
Estriol-17-beta (1400ug/dL)			+	+	+			+	+
Hemoglobin (500mg/dL)			---	---	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------		-	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Pregnanediol (1500ug/dL)			--	---	---	-----	I	+	+
Thiophene (20mg/dl)			+	+	+			+	t
Ampicillin (20mg/dl)			l	---	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------			---	--
Tetracycline(20mg/dl)			十一	+	+	l		------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Ketone(20mg/dl)			+	+	+			十	+

All data show that there is no interference for the listed compounds at the stated concentrations.

e. Effect of Urine Specified Gravity and Urine pH Negative and positive urine samples containing 0 and 20 mIU/mL hCG were tested at pH values from 4 to 9 using 3 different lots by 3 different operators. Typical results are shown in the following table.

		0 mlU/mL hCG		20mlU/mL hCG
pH	Operator	Operator	Operator	Operator	Operator	Operator
	A	B	C	A	B	C
4				+	+	+
5				+	+	---
б				+	+	+
7				+	+	+
8				+	+	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
ਰੇ				+	+	-

Negative and positive urine samples containing 5 and 20 mIU/mL hCG were tested at density values ranging from 1.000 to1.035 using 3 different lots by 3 different operators. Typical results are shown in the following table.

Specific Gravity (g/mL)	5 mlU/mL hCG			20mIU/mL hCG
	Operator A	Operator B	Operator C	Operator A	Operator B	Operator C
1.000	-	-	-	+	+	+
1.010	-	-	-	+	+	+
1.015	-	-	-	+	+	+
1.025	-	-	-	+	+	+
1.035	-	-	-	+	+	+

Data show that there is no interference from pH and specific gravity of tested urine samples.

1. Comparison Studies
  A method comparison study was performed, comparing the results obtained from the Fastep S10 hCG Serum/Urine Combo Test to the results from predicate devices (QVUE). 100 each urine or serum samples were collected from 100 women (about half of them were pregnant, early stage at less than 5 weeks). Samples were randomly collected at various times throughout the day. Ages ranged from 20 to 49 years. The samples were

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blind labeled. Samples were tested by three different health professionals with the proposed and the predicate devices. Each person could only perform tests for one device format. For example, a person who tested the strips could not test the cassettes. Each person tested three different lots of the device and one predicate device at the same time, but not sequentially. Typical results are shown in the following tables.

Summary Results for Urine Strip

New Device	Cleared device------------------------------------------------------------------------------------------------------------------------------------------------------------------------------		------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

	CAN AND IN - CHINES OF COLLEGION OF COLLEGION OF CA	Company come and an a cause posses	-----------For anywood and any and any and

Summary Results for Urine Cassette

	Cleared device		10-440-4000-0000-0000-00-00-00-00-00-00-00-00-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-
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Summary Results for Serum Strip

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Summary Results for Serum Cassette

The study result shows that over 95% agreements for positive samples, and 100% agreement for negative samples.

1. Clinical Studies
  Not applicable

11. Conclusion

Based on the test principle and acceptable performance characteristics including precision, cut-off, interference, specificity and method comparison of the devices, it's concluded that Fastep S10 hCG Serum/Urine Combo Test is substantially equivalent to the predicate.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is positioned to the right of a circular emblem containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 9, 2014

POLYMED THERAPEUTICS, INC C/O J.J XIA LSI INTERNATIONAL 12828 DOE LANE GAITHERSBURG MD 20878

Re: K132834

Trade/Device Name: Fastep S10 HCG Serum/Urine Combo Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: II Product Code: JHI Dated: November 18, 2013 Received: November 20, 2013

Dear Mr. Xia:

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. Iisting 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, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2-Mr. Xia

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-frec number (800) 638 2041 or (301) 796-7100 or at its Internet address, http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please notes the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Parti 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/McdicalDevices/Safety/ReportaProblem/default.html 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 tolli the (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/dcfault.htm.

Sincerely yours.

CourtneyH.Lias-S

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K132834

Device Name: Fastep S10 hCG Serum/Urine Combo Test

Indications for Use:

Prescription Use X (21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Denise Johnson-lyles -S

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

510(k) K132834

Regulation Number and Section

§ 862.1155 Human chorionic gonadotropin (HCG) test system.

(a)
Human chorionic gonadotropin (HCG) test system intended for the early detection of pregnancy —(1)Identification. A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class II.(b)
Human chorionic gonadotropin (HCG) test system intended for any uses other than early detection of pregnancy —(1)Identification. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class III.(3)
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 862.3.