(32 days)
The FIRST RESPONSE® 1-Step Pregnancy Test is an in vitro diagnostic test device intended for the early detection of pregnancy by the lay user up to four (4) days prior to the expected menses
The device detects the presence of hCG in the urine of a pregnant woman by a series of immunochemical reactions via component reagents striped onto a chromatographic strip contained within plastic housing.
Here's a breakdown of the acceptance criteria and study information for the FIRST RESPONSE® Pregnancy Test, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state quantitative acceptance criteria in the typical format of a performance study (e.g., "sensitivity must be > X%"). Instead, the acceptance criterion for this 510(k) essentially revolved around demonstrating that the device could reliably detect hCG earlier than its predicate while maintaining comparable performance.
The reported device performance is described in terms of its ability to detect hCG at various days before the expected period. While specific percentages are mentioned, they are presented as a revision/reinterpretation of existing data rather than new study outcomes against defined criteria.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Ability to detect hCG as early as four (4) days before the expected menses. | The device demonstrated the ability to detect hCG 4 days, 2 days, and 1 day before the expected period. (Specific percentages are not provided in this summary but are referenced as revised labeling based on reinterpreted data from K992232). |
| Performance comparable to predicate devices (FIRST RESPONSE® Pregnancy Test - K992232 and Clearblue Easy® Early Result - K013372). | The subject device and the predicate version of FIRST RESPONSE® are identical except for the number of early detection days. It is stated to be "very similar" to Clearblue Easy®, with "similar performance (per analytical and consumer study data previously provided)" in K992232. The reinterpreted data for the current submission also includes percentages for 3 days before and 2 days before the expected period (which differ due to a change in the basis of calculation, not underlying data changes). |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: The document does not explicitly state a sample size for a new test set in this 510(k) submission. It mentions that the sponsor "reinterpreted the same data provided in K992232." Therefore, the test set data originates from the studies performed for the predicate device, K992232.
- Data Provenance: The data is retrospective as it was previously acquired for K992232 and re-analyzed for the current submission. The country of origin is not specified in this document.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Number of Experts: This information is not provided in the document.
- Qualifications of Experts: This information is not provided in the document. Given the nature of a pregnancy test (detecting hCG in urine), ground truth would typically be established by confirmed pregnancy outcomes or quantitative laboratory hCG levels, rather than interpretation by clinical experts in the traditional sense.
4. Adjudication Method for the Test Set:
- The document does not specify an adjudication method. For a qualitative pregnancy test, ground truth is usually established by objective criteria (e.g., quantitative hCG levels, subsequent pregnancy confirmation), rather than subjective expert adjudication of the test result itself.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done as described in this document. The device is an in vitro diagnostic test, not an imaging or interpretive device that typically involves human readers in the same way clinical algorithms do. The "consumer study data" mentioned from the predicate (K992232) might refer to usability or non-expert interpretation, but not a formal MRMC study comparing human readers with and without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:
- Yes, this submission describes standalone performance. The device itself is a standalone, over-the-counter diagnostic test that provides a result without requiring human interpretation beyond reading the result line(s). The performance data cited relates directly to the device's ability to detect hCG. There is no "human-in-the-loop" aspect to its primary function of detection.
7. Type of Ground Truth Used:
- The ground truth used was based on quantitative hCG levels and likely confirmed pregnancy outcomes (as implied by "percentage of women in which the device detected the hormone X days before... expected period" and "conceptive cycles"). The predicate test's claims were based on "the percentage of cycles having quantitative hCG levels approximating the claimed sensitivity level or greater."
8. Sample Size for the Training Set:
- The document does not provide a specific sample size for a training set. Since this submission reinterpreted data from a prior 510(k) (K992232), any "training" or development data would have originated from that earlier submission, and its details are not present here.
9. How the Ground Truth for the Training Set Was Established:
- Similar to the test set, the ground truth for any underlying development/training from the K992232 submission would have been established by quantitative hCG levels and/or confirmed pregnancy outcomes. The text specifically mentions "hCG levels approximating the claimed sensitivity level or greater."
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510(K) SUBSTANTIAL EQUIVALENCE REVIEW SUMMA
Item Section
Information
FEB 2 5 2003
- (1) Applicant Information
- Company Name: Armkel, LLC A
- Mailing Address: 469 North Harrison St. B
- Princeton, NJ 08543-5297
- Phone #: (609) 279-7748 C
- Fax#: (609) 497-7179 D
- Email address (optional): E
STEPHEN.KOLAKOWSKY@CHURCHDWIGHT.COM
- Contact: Stephen C. Kolakowsky F
- Director, Regulatory Affairs
Proprietary & Established Names (2)
FIRST RESPONSE® Pregnancy Test
Regulatory Information (3)
- Product Code: LCX (Panel 75) A
- B Classification: II
- C CFR number: 21 CFR §862.1155
- D Regulation name: Human chorionic gonadotropin (HCG) test system
(4) Intended Use(s)
- Analyte: Human Chorionic Gonadotropin A
- Type of test: Qualitative ਤਿ
- Specimen: Urine C
- Special instrument requirements: N/A D
- Special condition for use statement(s): OTC use only E
(5) Substantial Equivalence Information
- A Predicate Device(s): FIRST RESPONSE® Pregnancy Test (FR)
- Clearblue Easy® Early Result Pregnancy Test (CB)
- 510(k) number(s): K992232 (FR), K013372 (CB) B
- Comparison with predicate: The subject device and ಲ
the predicate version of the FIRST RESPONSE® Pregnancy Test are identical. They differ only in the number of days prior to the expected menses the device can be used. The subject device is also very similar to the Clearblue Easy®. Both have the same intended use, both are immunochromatographic assays, both have similar test procedures, and both have similar performance (per analytical and consumer study data previously provided).
(6) Test Principle
The device detects the presence of hCG in the urine of a pregnant woman by a series of immunochemical reactions via component reagents striped onto a chromatographic strip contained within plastic housing. For additional details, refer to K992232.
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510(K) SUBSTANTIAL EQUIVALENCE REVIEW SUMMARY
Specific Performance Characteristics (7)
- A Method comparison:
- Matrix comparison: B
- C Accuracy determination:
- Matrix comparison: D
- ದಿ Precision:
- F Analytical Sensitivity:
- Analytical Specificity: G
- Clinical or Diagnostic Sensitivity: H
- Clinical or Diagnostic Specificity: I
- J Cut-off(s):
- K Expected Values:
Please refer to K992232 for details on the specific performance characteristics.
(8) Other Relevant Information
The sponsor submitted this 510(k) to modify the number of days prior to the expected menses the device could be used. The FIRST RESPONSE® Pregnancy Test predicate version may be used as early as three (3) days before the expected menses and the Clearblue Easy® Early Result Pregnancy Test (predicate) may be used as early as four (4) days before the expected period. The subject device is proposed for use as early as four (4) days before the expected period.
As discussed on August 6, 2002 in a meeting between Church & Dwight Co., Inc. and FDA and in subsequent conversations, the sponsor has reinterpreted the same data provided in K992232 and revised the labeling to reflect the percentage of women in which the device detected the hormone 4 days before-, 2 days before-, 2 days before-, and 1 day before their expected period. Additionally, although there were no changes to the data set, the percentages for 3 days before-, 2 days before-, and 1 day before the expected period differ from those previously provided in the labeling. This is because the predicate test's claims were based on the percentage of cycles having quantitative hCG levels approximating the claimed sensitivity level or greater, even though hCG was detected days earlier in many of the conceptive cycles.
Veronica J. Calvin
eronica J. Calvin, M.A. Scientific Reviewer
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
ArmKel, LLC c/o Mr. Stephen C. Kolakowsky Director Regulatory Affairs Church & Dwight Co., Inc. 469 North Harrison Street Princeton, NJ 08543-5297
FEB 2 5 2003
Re: K030258
Trade/Device Name: First Response® 1-Step Pregnancy Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: LCX Dated: January 23, 2003 Received: January 24, 2003
Dear Mr. Kolakowsky:
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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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 (301) 594-3084. 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/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number:
Device Name:
Indications for Use:
FIRST RESPONSE® 1-Step Pregnancy Test
The FIRST RESPONSE® 1-Step Pregnancy Test is an in vitro diagnostic test device intended for the early detection of pregnancy by the lay user up to four (4) days prior to the expected menses
Jan Cooper
(Division Sign-Off)
Division of Clinical La
510(k) Number: K030258
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use (Per 21 CFR §801.109) Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
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§ 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.