The OSOM hCG Combo test is a rapid immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine or serum as an aid in the early detection of pregnancy. This test is for use in physicians' offices and clinical laboratories.

Device Description

The OSOM hCG Combo device is a solid phase, sandwich-format immunochromatographic assay for the qualitative detection of hCG. Urine or serum is added to the sample well of the test device using the fixed volume Pipette provided. The sample migrates through reaction pads where hCG, if present in the sample, binds to a monoclonal anti-hCG dye conjugate. The sample then migrates across a membrane towards the results window, where the labeled hCG complex is captured at a test line region containing immobilized rabbit anti-α hCG. Excess conjugate will flow past the test line region and be captured at a control line region containing an immobilized antibody directed against the anti-hCG dye conjugate (with or without hCG complexed to it). The appearance of two gray or black bands in the results window indicates the presence of hCG in the sample. If a detectable level of the hCG is not present, only the control band will appear in the results window.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the OSOM hCG Combo test, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Agreement with a currently marketed qualitative hCG assay.	Urine samples: >99% agreement for both positive and negative results.
	Serum samples: >99% agreement for both positive and negative results.

Study Details

1. Sample Sized used for the test set and the data provenance:

Urine Test Set: 634 samples
Serum Test Set: 691 samples
Data Provenance: Not explicitly stated whether retrospective or prospective, nor the country of origin.

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

Not explicitly stated. The comparison was made against a "currently marketed qualitative hCG assay," implying the predicate device's results were accepted as the reference.

3. Adjudication method for the test set:

Not applicable/Not explicitly stated. The comparison was a direct agreement with a predicate device. There is no mention of independent expert adjudication.

4. 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, an MRMC comparative effectiveness study was not done. This device is a rapid immunoassay for qualitative detection, not an AI-assisted diagnostic tool.

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

Yes, this was a standalone performance study. The device itself performs the detection and provides a visual result (bands). The study assesses the device's accuracy in producing these results compared to a reference standard.

6. The type of ground truth used:

The ground truth was established by comparison to the results obtained with a currently marketed qualitative hCG assay (presumably the predicate device, Quidel QuickVue®+ One-Step hCG Combo Test). This implies a comparative agreement study where the predicate device serves as the reference standard.

7. The sample size for the training set:

Not applicable/Not explicitly stated. This device is a traditional immunoassay, not a machine learning or AI-based system that typically requires a discrete training set. The "development" and "validation" would rely on analytical studies and clinical performance rather than a separate "training set" in the AI sense.

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

Not applicable (as per point 7).

Summary

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K 043385

510(k) SUMMARY

APR 1 2 2005

Pursuant to Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, Genzyme Corporation is providing a summary of the safety and effectiveness information available for the OSOM hCG Combo test.

Sponsor/Applicant Name and Address: 1.
Genzyme Corporation 500 Kendall Street Cambridge, MA 02142
Sponsor Contact Information: 2.
E.V. Goorchenko Director of Regulatory Affairs Phone: 858/777-2614 FAX: 858/452-3258 Email: Gene.Goorchenko@genzyme.com
Date of Preparation of 510(k) Summary: 3. February 22, 2005
Device Trade or Proprietary Name: 4.

OSOM hCG ComboTest

Device Common/Usual or Classification Name: 5.
hCG Test System

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Legally Marketed Devices to which Equivalence is Being Claimed: 6.

Quidel QuickVue®+ One-Step hCG Combo Test (K)

Device Description 7.

Intended Use

The Genzyme Diagnostics OSOM hCG Combo test is a rapid immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine or serum as an aid in the early detection of pregnancy. This test is for use in physicians' offices and clinical laboratories.

Principle of the Device

The OSOM hCG Combo device is a solid phase, sandwich-format immunochromatographic assay for the qualitative detection of hCG. Urine or serum is added to the sample well of the test device using the fixed volume Pipette® provided. The sample migrates through reaction pads where hCG, if present in the sample, binds to a monoclonal anti-hCG dye conjugate. The sample then migrates across a membrane towards the results window, where the labeled hCG complex is captured at a test line region containing immobilized rabbit anti-α hCG. Excess conjugate will flow past the test line region and be captured at a control line region containing an immobilized antibody directed against the anti-hCG dye conjugate (with or without hCG complexed to it).

The appearance of two gray or black bands in the results window indicates the presence of hCG in the sample. If a detectable level of the hCG is not present, only the control band will appear in the results window.

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Comparison of Technological Characteristics of OSOM hCG Combo with 8. Legally Marketed Device:

The similarities with, and differences between, the OSOM hCG Combo test and the Quidel QuickVue®+ One-Step device are described in Table 1.

Agreement with Predicate Device: 9.

A total of 634 urine samples and 691 serum samples were tested and compared to the results obtained with a currently marketed qualitative hCG assay. The agreement for the OSOM urine procedure, on both positive and negative samples, was >99% and, for the OSOM serum procedure, agreement on both positive and negative samples was >99%.

	Genzyme OSOM hCGCombo Test	QuidelQuickVue®+ hCG-Combo Test
Assay Format	Lateral flowimmunoassay	Lateral flow immunoassay
Result Format	Visible lines:Negative=one gray orblack Control LinePositive=one gray orblack Control Line andone gray or black TestLine	Visible lines:Negative =two blue linesPositive = one pink lineand two blue lines.
Specimen	Urine or Serum	Urine or Serum
Antibodies	Mouse monoclonal andrabbit polyclonal	Mouse monoclonal andgoat polyclonal

Table 1. Summary of Device Similarities and Differences

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Internal Control	Yes	Yes
TimeToResult	Urine: Read result at 3minutesSerum: Read result at 5minutes	Urine: Read result at 3minutesSerum: Read result at 5minutes
AnalyticalSensitivity	Urine: 20 mIU/mLSerum: 10 mIU/mL	Urine: 20 mIU/mLSerum: 10 mIU/mL

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APR 】 2 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Gene Goorchenko Director of Regulatory Affairs Genzyme Diagnostics 6659 Top Gun Street San Diego, CA 92121

K043385 Re:

Trade/Device Name: OSOM hCG Combo Regulation Number: 21 CFR 862.1155 Regulation Name: Urinary pH (nonquantitative ) test system Regulatory Class: Class II Product Code: JHI Dated: March 18, 2005 Received: March 21, 2005

Dear Mr. Goorchenko:

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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

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

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240)276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Sean M. Cooper MS, DUM

Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number: K

510(k) Number:

Device Name: OSOM hCG Combo

Indications for Use: The OSOM hCG Combo test is a rapid immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine or serum as an aid in the early detection of pregnancy. This test is for use in physicians' offices and clinical laboratories.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign Off

Division /Sign-Off

Office of In Vitro Diagn Device Evaluation an

510(k) K093385

Page 1 of

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.